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Showing 374 of 374 trials
NCT06337318
A study for patients with previously untreated, low tumor burden follicular lymphoma.
Key Inclusion Criteria:
- Histologically confirmed classic follicular lymphoma (cFL) or uFL.
- Low-tumor burden disease (e.g., mass < 7 cm, no B symptoms).
Key Exclusion Criteria:
- Blastoid/large centrocyte features or follicular large B-cell lymphoma (FLBL).
- Prior allogeneic stem cell transplantation.
NCT06422806
A study for patients with metastatic or unresectable dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS), or related poorly differentiated sarcomas.
Key Inclusion Criteria:
- Histology: DDLPS, UPS, or related poorly differentiated sarcoma.
- Metastatic or unresectable disease.
Key Exclusion Criteria:
- Prior treatment with an anthracycline.
- Prior therapy with an anti-PD-1, anti-PD-L1/L2, or anti-CTLA-4 agent.
NCT06439836
A trial for patients with progressive metastatic or unresectable urothelial cancer who have previously received immunotherapy.
Key Inclusion Criteria:
- Metastatic or unresectable urothelial cancer.
- Prior treatment with a PD-1/PD-L1 inhibitor required.
Key Exclusion Criteria:
- Prior Grade ≥ 3 immune-related adverse event from PD-1/PD-L1 blockade.
- Active autoimmune disease requiring systemic treatment in the last 2 years.
NCT06484062
A study for patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS).
NCT06498635
A study for patients with resected Stage II-IIIB non-small cell lung cancer (NSCLC) who had a complete response to neoadjuvant chemo-immunotherapy.
Key Inclusion Criteria:
- Clinical stage II-IIIB (excluding N3) NSCLC.
- Complete (R0) resection within 84 days of randomization.
Key Exclusion Criteria:
- Known EGFR mutations or ALK gene fusion.
- Prior post-operative radiation therapy (PORT).
NCT06770582
A study for patients with high-grade T1 non-muscle invasive bladder cancer.
Key Inclusion Criteria:
- Pathologically proven T1 high-grade urothelial carcinoma of the bladder (N0, M0).
- Meets criteria for high-risk T1 disease (e.g., recurrence post-BCG, LVI, variant histology).
Key Exclusion Criteria:
- Histology other than urothelial (e.g., squamous, adenocarcinoma, neuroendocrine).
- Diffuse carcinoma in situ (CIS) or prostatic urethral involvement.
NCT05675410
For patients with newly diagnosed, untreated Stage I or II classic Hodgkin lymphoma.
Key Inclusion Criteria:
- Histologically confirmed classic Hodgkin lymphoma (cHL), Stage I or II.
- Bidimensionally measurable disease (lesion >= 1.5 cm).
Key Exclusion Criteria:
- Nodular lymphocyte predominant Hodgkin lymphoma.
- Active interstitial pneumonitis or interstitial lung disease.
NCT04071236
A study for patients with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases that has progressed after prior therapies.
Key Inclusion Criteria:
- Metastatic castration-resistant prostate cancer (mCRPC) with ≥2 skeletal metastases.
- Progression after ≥1 prior line (abiraterone, enzalutamide, apalutamide, darolutamide, or taxane).
Key Exclusion Criteria:
- Imminent/established spinal cord compression or pathological fracture.
- Active autoimmune conditions or chronic immunosuppression.
NCT05256225
A study for patients with HER2-positive, Stage I-IV endometrial serous carcinoma or carcinosarcoma.
Key Inclusion Criteria:
- Stage IA-IVB, non-recurrent, chemo-naive endometrial cancer.
- HER2-positive disease (IHC 3+, IHC 2+/ISH+, or ERBB2 amplified).
Key Exclusion Criteria:
- Prior chemotherapy, biologic, or targeted therapy for endometrial cancer.
- Prior radiation therapy for endometrial cancer.
NCT03866382
A study of nivolumab, ipilimumab, and cabozantinib for patients with various rare, metastatic genitourinary tumors.
Key Inclusion Criteria:
- Histologically confirmed rare GU tumor from one of the specified cohorts.
- Metastatic disease with at least one measurable lesion per RECIST 1.1.
Key Exclusion Criteria:
- Active or symptomatic brain metastases.
- Prior treatment with cabozantinib.
NCT05640843
A study for patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM).
Key Inclusion Criteria:
- Confirmed diagnosis of MGUS or SMM.
- Must meet specific M-spike, light chain, or bone marrow plasma cell criteria.
Key Exclusion Criteria:
- Already follows a whole foods plant-based diet.
- Concurrent participation in other weight loss, dietary, or exercise programs.
NCT06203600
A study for patients with advanced, unresectable, or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma.
Key Inclusion Criteria:
- PD-L1 CPS ≥ 1.
- Microsatellite stable (MSS) and HER2-negative adenocarcinoma.
Key Exclusion Criteria:
- History of grade ≥3 immunotherapy-related toxicity requiring discontinuation.
- Systemic corticosteroids (>10 mg/day prednisone) or immunosuppressants within 14 days.
NCT06568172
A study for patients with resectable Stage III or IV cutaneous squamous cell carcinoma (skin cancer).
Key Inclusion Criteria:
- Resectable Stage III or IV cutaneous squamous cell carcinoma (CSCC).
- Previously untreated or recurrent disease.
Key Exclusion Criteria:
- Distant metastatic disease (M1).
- Prior systemic therapy or radiotherapy to the study region.
NCT04628767
A study for patients with high-grade upper tract urothelial carcinoma (UTUC) who are candidates for surgery.
Key Inclusion Criteria:
- Histologically confirmed high-grade upper tract urothelial carcinoma (UTUC).
- Must be a candidate for nephroureterectomy.
Key Exclusion Criteria:
- Metastatic disease or clinically enlarged regional lymph nodes (≥ 1.5 cm).
- Any component of small cell/neuroendocrine carcinoma.
NCT06860594
A trial for patients with recurrent glioblastoma or astrocytoma, including IDH-mutant and IDH-wildtype subtypes.
Key Inclusion Criteria:
- Histologically confirmed recurrent astrocytic tumors (GBM, astrocytoma, diffuse midline glioma).
- At least a 6-month break from last dose of radiation therapy.
Key Exclusion Criteria:
- Currently receiving other investigational agents.
- Actively taking medications known to induce methemoglobinemia.
NCT04981509
A study for patients with advanced hereditary leiomyomatosis and renal cell cancer (HLRCC) or sporadic papillary renal cell cancer.
Key Inclusion Criteria:
- Diagnosis of HLRCC with RCC or sporadic/non-HLRCC papillary RCC.
- Advanced RCC with measurable disease.
Key Exclusion Criteria:
- No prior bevacizumab, PD-1, or PD-L1 inhibitors in the metastatic setting.
- History of autoimmune disease (some exceptions apply).
NCT04671667
A study for patients with recurrent or second primary head and neck squamous cell carcinoma (HNSCC) who have undergone surgery.
Key Inclusion Criteria:
- Recurrent or second primary HNSCC in a previously radiated field.
- Undergone gross total resection within 8 weeks of randomization.
Key Exclusion Criteria:
- Any evidence of distant (metastatic) disease.
- Prior anti-PD-1/PD-L1 therapy for recurrent disease.
NCT04858334
For patients with resected pancreatic cancer and a pathogenic BRCA1, BRCA2, or PALB2 mutation who have completed curative intent therapy.
Key Inclusion Criteria:
- Pathogenic/likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2.
- Successfully undergone curative intent surgical resection.
Key Exclusion Criteria:
- Progressive disease during prior platinum-based therapy.
- History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
NCT01810913
For patients with high-risk, resected Stage III-IV squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, or hypopharynx).
NCT05896839
A trial for kidney transplant recipients with unresectable or metastatic skin cancer, including melanoma, basal cell carcinoma, Merkel cell carcinoma, or cutaneous squamous cell carcinoma.
NCT02339571
A study for patients with unresectable Stage III or Stage IV melanoma.
Key Inclusion Criteria:
- Histologically confirmed unresectable Stage III or IV melanoma.
- Known BRAF mutational status (WT or mutated).
Key Exclusion Criteria:
- Prior ipilimumab or anti-PD-1/PD-L1 therapy for metastatic disease.
- Active or untreated CNS metastases.
NCT05904080
A study for patients with recurrent, metastatic, or incurable nasopharyngeal cancer that has progressed after prior platinum and immunotherapy.
Key Inclusion Criteria:
- Recurrent, metastatic, or incurable nasopharyngeal carcinoma (NPC).
- Progressed after platinum-gemcitabine and a PD-1/L1 blockade.
Key Exclusion Criteria:
- Prior VEGFR targeted therapy.
- Active or recurrent autoimmune disease requiring systemic treatment.
NCT05536141
A study for patients with clear cell renal cell carcinoma (ccRCC) or other advanced solid tumors.
Key Inclusion Criteria:
- Dose Escalation: Pathologically confirmed solid tumor with no other available treatment options.
- Dose Expansion: Histologically confirmed clear cell renal cell carcinoma (ccRCC).
Key Exclusion Criteria:
- Prior treatment with a HIF-2α inhibitor (for expansion cohorts).
- Prior treatment with cabozantinib (for casdatifan + cabozantinib cohort).
NCT05691504
A study for patients with recurrent or metastatic ovarian, fallopian tube, primary peritoneal, or endometrial cancer.
Key Inclusion Criteria:
- Ovarian cancer must be platinum-resistant (progression within 6 months of platinum).
- Must have received at least one prior line of platinum-based therapy.
Key Exclusion Criteria:
- Prior treatment with any BCL family inhibitors.
- Currently receiving other investigational agents.
NCT05987241
For patients with surgically resected, high-risk, muscle-invasive urothelial carcinoma of the bladder, kidney, ureter, or urethra.
Key Inclusion Criteria:
- High-risk, muscle-invasive urothelial carcinoma (pT3-4/N+ or post-neoadjuvant ypT2-4a/N+).
- Radical surgery (e.g., cystectomy) completed 3-12 weeks prior.
Key Exclusion Criteria:
- Prior adjuvant systemic therapy or radiation post-surgery.
- Prior treatment with LAG-3 blockade.
NCT04181060
A study for patients with advanced or metastatic EGFR-mutant non-squamous non-small cell lung cancer (NSCLC).
Key Inclusion Criteria:
- Pathologically confirmed non-squamous NSCLC.
- Stage IV, unresectable Stage IIIB, or recurrent disease.
Key Exclusion Criteria:
- Any prior systemic therapy for metastatic disease.
- Prior treatment with an anti-VEGF agent.
NCT06029270
A study for patients with recurrent or metastatic Epstein-Barr virus-associated nasopharyngeal carcinoma.
Key Inclusion Criteria:
- Recurrent/metastatic NPC not amenable to curative surgery or re-irradiation.
- Tumor must be EBER-positive or have history of detectable plasma EBV DNA.
Key Exclusion Criteria:
- Prior systemic therapy for recurrent/metastatic NPC.
- Prior PD-1, PD-L1, LAG-3, or CTLA-4 inhibitors for R/M disease.
NCT06050252
A study of durvalumab with chemotherapy for patients with high-risk, resectable intrahepatic cholangiocarcinoma (liver cancer) before surgery.
Key Inclusion Criteria:
- High-risk features (tumor >5cm, multifocality, vascular invasion, or CA19-9 >200).
- Suspected or confirmed regional lymph node metastases.
Key Exclusion Criteria:
- Active or prior autoimmune/inflammatory disorders (some exceptions apply).
- History of allogenic organ transplantation.
NCT06058377
A study for patients with Stage II-III, hormone receptor-positive, HER2-negative breast cancer with a high-risk MammaPrint score.
Key Inclusion Criteria:
- MammaPrint High 2 Risk (MP2) score required.
- Clinical stage II or III disease.
Key Exclusion Criteria:
- Metastatic disease (clinically M1).
- Locally recurrent breast cancer.
NCT05327010
A trial for patients with advanced, metastatic, or unresectable solid tumors with specific genetic mutations.
Key Inclusion Criteria:
- Must have specific mutations: BRCA1/2, DDR genes (non-BRCA), or KRAS.
- Prior PARP inhibitor therapy required for BRCA/DDR cohorts.
Key Exclusion Criteria:
- Prior treatment with ZEN003694 or any investigational BET inhibitor.
- Symptomatic brain metastases requiring steroids or any carcinomatous meningitis.
NCT04402788
A study for patients with extensive stage small cell lung cancer (ES-SCLC) who have not progressed after initial chemotherapy and immunotherapy.
Key Inclusion Criteria:
- Partial response or stable disease after 4-6 cycles of etoposide/platinum + atezolizumab.
- Measurable disease per RECIST with no evidence of progression at enrollment.
Key Exclusion Criteria:
- >3 liver metastases, heart metastases, or >10 total metastatic sites.
- History of immunotherapy-induced pneumonitis.
NCT06120075
A study for patients with various advanced solid tumors, including a specific cohort for non-small cell lung cancer (NSCLC).
Key Inclusion Criteria:
- Dose Expansion: Locally advanced/metastatic non-squamous NSCLC (Stage IIIB-IV).
- Dose Expansion (NSCLC): Negative for EGFR, ALK, ROS1, NTRK, C-MET, or RET mutations.
Key Exclusion Criteria:
- Active or documented history of autoimmune disease within 3 years.
- Systemic immunosuppressive medication within 2 weeks of study treatment.
NCT07080242
A study for patients with locally advanced or metastatic Small Cell Lung Cancer (SCLC) and other Neuroendocrine Tumors.
Key Inclusion Criteria:
- Locally advanced or metastatic SCLC, LCNEC, NEPC, high-grade GI-NET, MCC, or other NETs.
- For other NETs, neuroendocrine histology must be ≥10%.
Key Exclusion Criteria:
- Prior treatment with a topoisomerase inhibitor-based ADC.
- Primary CNS tumors or active/untreated CNS metastases.
NCT05238922
A study for patients with various advanced or metastatic solid tumors, including specific cohorts for gynecologic, gastrointestinal, and breast cancers.
Key Inclusion Criteria:
- Histologically confirmed advanced or metastatic solid tumor.
- Specific cohorts for gynecologic, GI, and breast cancers.
Key Exclusion Criteria:
- Untreated or progressive brain/CNS metastases.
- Prior treatment with any CDK2 inhibitor.
NCT00196742
A registry study for patients with a confirmed diagnosis of Fabry Disease.
Key Inclusion Criteria:
- Confirmed diagnosis by deficient αGAL enzyme activity or αGAL gene mutation.
- For Pregnancy Sub-registry: Must be enrolled in the main Fabry Registry.
NCT04427384
A registry study for patients with various types of brain tumors, including primary, recurrent, and metastatic, who are treated with GammaTile radiation therapy.
Key Inclusion Criteria:
- Underwent maximum safe resection of intracranial neoplasm and implantation of GammaTiles.
Key Exclusion Criteria:
- Inability to undergo pre- and post-operative imaging for assessment.
NCT07217171
A study for patients with advanced or metastatic urothelial cancer or various types of squamous cell carcinomas.
Key Inclusion Criteria:
- Documented disease progression during or after standard of care therapy.
- Measurable disease by CT or MRI.
Key Exclusion Criteria:
- Candidate for a targeted agent known to provide benefit.
- Brain metastases unless previously treated and stable.
NCT05157581
A study for patients with Sezary syndrome.
Key Inclusion Criteria:
- Must have stage IVA1 Sezary syndrome.
- Minimum 3-week washout from prior systemic therapy.
Key Exclusion Criteria:
- Visceral metastasis of lymphoma.
- Concomitant radiotherapy or systemic anti-cancer therapy.
NCT06112613
A study for patients with hormone receptor-positive (HR+), HER2-negative metastatic breast cancer.
Key Inclusion Criteria:
- Pathologically proven HR+, HER2- metastatic breast cancer.
- Initiating a CDK4/6 inhibitor within 30 days of consent.
Key Exclusion Criteria:
- Prior treatment with any CDK4/6 inhibitor (palbociclib, ribociclib, abemaciclib).
- Currently enrolled in a therapeutic trial that monitors CDK4/6 inhibitors.
NCT05243797
A study for patients with newly diagnosed multiple myeloma receiving maintenance therapy after autologous stem cell transplantation.
Key Inclusion Criteria:
- Post-autologous stem cell transplant (ASCT).
- Received only one prior line of therapy (induction +/- consolidation).
Key Exclusion Criteria:
- Disease progression at any time prior to screening.
- Prior BCMA-directed therapy.
NCT03937635
A study for patients with high-risk smoldering multiple myeloma.
Key Inclusion Criteria:
- Diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within 12 months.
- High-risk defined by ≥2 factors (abnormal FLC ratio, M-protein ≥2g/dL, high-risk cytogenetics, >20% plasma cells).
Key Exclusion Criteria:
- Any prior systemic or radiation therapy for myeloma.
- Monoclonal gammopathy of undetermined significance (MGUS).
NCT06586957
A study for adults with various advanced or metastatic solid tumors, including specific cohorts for ovarian, endometrial, gastric, esophageal, small cell lung, and breast cancers.
Key Inclusion Criteria:
- Advanced, unresectable or metastatic solid tumor with documented progression.
- Must fit into a specified cohort (e.g., ovarian, endometrial, breast, gastric, SCLC).
Key Exclusion Criteria:
- Candidate for curative-intent therapy.
- Active CNS metastases or carcinomatous meningitis.
NCT05614739
A study for patients with locally advanced or metastatic solid tumors, including urothelial cancer, that have an FGFR3 gene alteration.
Key Inclusion Criteria:
- Locally advanced or metastatic solid tumor with an actionable FGFR3 alteration.
- Histological diagnosis of urothelial cancer (UC) or other solid tumor.
Key Exclusion Criteria:
- Primary central nervous system (CNS) malignancy.
- Untreated or uncontrolled CNS metastases.
NCT05863195
A study for patients with unresectable colorectal cancer that has metastasized to the liver.
Key Inclusion Criteria:
- Unresectable, liver-confined metastatic colorectal cancer.
- Received 3-6 months of first-line chemotherapy.
Key Exclusion Criteria:
- Liver tumor burden >70% of total liver volume.
- Microsatellite instability-high (MSI-H) disease.
NCT05721755
A study for patients with metastatic squamous cell carcinoma of the head and neck (oral cavity, larynx, oropharynx, or hypopharynx).
Key Inclusion Criteria:
- Biopsy-proven metastatic HNSCC (oral cavity, larynx, oropharynx, hypopharynx).
- Oligometastatic disease (4 or fewer metastatic sites).
Key Exclusion Criteria:
- Prior head and neck radiotherapy.
- Active autoimmune disease requiring systemic treatment within the last 2 years.
NCT04256317
A study for patients with myeloid neoplasms, including myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), or newly diagnosed acute myeloid leukemia (AML).
Key Inclusion Criteria:
- Phase 2/3: Confirmed MDS or CMML, candidate for single agent azacitidine.
- Phase 1 Combo: Newly diagnosed AML.
Key Exclusion Criteria:
- Phase 1 Combo: Prior treatment with a hypomethylating agent or venetoclax.
- Phase 2/3 Mono: Prior treatment with >1 cycle of decitabine, azacitidine, or guadecitabine.
NCT02734537
A study for patients with surgically resected, Stage III-IVA squamous cell carcinoma of the head and neck.
NCT02926690
A study for patients with relapsed/refractory locally advanced or metastatic breast cancer, including a specific cohort for triple-negative breast cancer.
Key Inclusion Criteria:
- Relapsed/refractory to standard therapy or no standard therapy available.
- Dose expansion cohort: Must have TNBC (ER<10%, PR<10%, HER2-negative).
Key Exclusion Criteria:
- Known CNS or leptomeningeal metastases not controlled by prior therapy.
- Primary brain tumors or any hematologic malignancy.
NCT03493425
A study for patients with resectable, locally advanced (Stage III or IVA) squamous cell carcinoma of the nasal cavity and paranasal sinuses.
Key Inclusion Criteria:
- Histologically-confirmed T3 or T4a NPNSCC requiring orbital or skull base resection.
- Disease must be deemed surgically resectable.
Key Exclusion Criteria:
- Evidence of distant metastases or leptomeningeal disease.
- Prior irradiation for head/neck tumor, skull base, or brain tumors.
NCT04683653
A study of adjuvant pelvic hypofractionated radiotherapy for patients with non-metastatic cervical and endometrial cancer.
Key Inclusion Criteria:
- Treated with definitive hysterectomy.
- No gross residual disease post-operatively.
Key Exclusion Criteria:
- Distant metastatic disease.
- Gross residual disease post-operatively.
NCT06263543
A study for patients with metastatic, hormone receptor-positive (ER+), HER2-low or ultra-low breast cancer.
Key Inclusion Criteria:
- HER2 LOW (IHC 2+/ISH- or IHC 1+) or HER2 ULTRA LOW (IHC0+ faint staining).
- Hormone receptor positive (ER+ and/or PR+ >1%).
Key Exclusion Criteria:
- Brain metastases, unless treated, stable, asymptomatic, and off steroids.
- Locally advanced (Stage IIIc) disease if eligible for curative intent therapy.
NCT05128825
A study for patients with platinum-resistant, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.
Key Inclusion Criteria:
- Platinum-resistant disease.
- Tumor is Cyclin E1 positive by central IHC testing.
Key Exclusion Criteria:
- Primary platinum-refractory disease.
- Prior therapy with a WEE1, ATR, PKMYT1, or CHK1/2 inhibitor.
NCT03486873
For patients with advanced solid tumors or hematologic malignancies who are continuing treatment from a prior pembrolizumab study.
Key Inclusion Criteria:
- Must have been treated in a designated parent pembrolizumab study.
- Currently receiving pembrolizumab-based therapy or in follow-up from parent study.
Key Exclusion Criteria:
- For Second Course: Active CNS metastases or carcinomatous meningitis.
- For Second Course: Active autoimmune disease requiring systemic therapy in prior 2 years.
NCT06925737
A study for patients with metastatic castration-resistant prostate cancer (mCRPC).
Key Inclusion Criteria:
- Progression on androgen deprivation therapy (ADT) within 6 months of study entry.
- Received 1 or 2 prior androgen receptor pathway inhibitors (ARPI).
Key Exclusion Criteria:
- Prior taxane-based chemotherapy for mCRPC.
- History of non-infectious interstitial lung disease (ILD)/pneumonitis requiring steroids.
NCT06158841
A study for adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy.
Key Inclusion Criteria:
- At least 2 prior lines of therapy, including a PI, IMiD, and anti-CD38 mAb.
- Relapsed or refractory (R/R) multiple myeloma.
Key Exclusion Criteria:
- Prior B-cell maturation antigen (BCMA)-targeted therapy.
- Central nervous system (CNS) involvement of multiple myeloma.
NCT06119581
A first-line study for patients with advanced or metastatic KRAS G12C-mutant non-small cell lung cancer (NSCLC).
Key Inclusion Criteria:
- Confirmed KRAS G12C mutation.
- Stage IIIB-IV NSCLC, not suitable for curative intent therapy.
Key Exclusion Criteria:
- Documented oncogenic driver mutations (e.g., EGFR, ALK, ROS1).
- Prior systemic therapy for advanced or metastatic disease.
NCT07226843
A study for adult participants with previously treated blood cancers, including Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma.
Key Inclusion Criteria:
- Diagnosis of DLBCL-NOS, HGBCL, FL, or other NHL.
- Received at least 2 prior lines of systemic therapy.
Key Exclusion Criteria:
- Known or suspected CNS involvement.
- Active second malignancy.
NCT06312137
For patients with resectable Stage II-IIIB non-small cell lung cancer (NSCLC) who did not achieve a pathological complete response after neoadjuvant therapy and surgery.
Key Inclusion Criteria:
- Resectable Stage II, IIIA, or IIIB (N2) NSCLC.
- No indication for primary EGFR or ALK-directed therapy.
Key Exclusion Criteria:
- Superior sulcus tumors or specific histologies (LCNEC, sarcomatoid, SCLC elements).
- Active autoimmune disease requiring systemic treatment within past 2 years.
NCT05768139
A study for patients with advanced, metastatic, or unresectable solid tumors, including breast cancer, with a documented PI3Kα mutation.
Key Inclusion Criteria:
- Advanced, metastatic, or unresectable solid tumor.
- Tumor must have a documented PI3Kα mutation.
Key Exclusion Criteria:
- Prior treatment with any PI3K/AKT/mTOR inhibitor.
- Symptomatic brain or spinal metastases.
NCT05514054
A study for patients with ER+, HER2- early-stage breast cancer with an increased risk of recurrence.
Key Inclusion Criteria:
- ER+, HER2- resected invasive breast cancer.
- Received 2-5 years of prior adjuvant endocrine therapy (ET).
Key Exclusion Criteria:
- Inflammatory breast cancer at primary diagnosis.
- Prior endocrine therapy for breast cancer prevention (tamoxifen, AIs, raloxifene).
NCT06838676
A study for children and adults with newly diagnosed, progressive, or recurrent Diffuse Intrinsic Pontine Gliomas (DIPG) or H3K27-altered High Grade Gliomas.
NCT06690775
A study for women with advanced, platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer that expresses Claudin 6.
Key Inclusion Criteria:
- Advanced/metastatic high-grade serous ovarian, primary peritoneal, fallopian tube, or high-grade endometrioid cancer.
- Tumor must be positive for CLDN6 expression via central testing.
Key Exclusion Criteria:
- Histologies: clear cell, mucinous, sarcomatous, low-grade, or non-epithelial.
- Primary platinum-refractory disease (progressed <3 months after first-line platinum).
NCT05928806
A study for treatment-naive patients with advanced or metastatic renal cell carcinoma (RCC) with a clear cell component.
Key Inclusion Criteria:
- Histologically confirmed advanced or metastatic RCC with clear cell component.
- Measurable disease per RECIST 1.1.
Key Exclusion Criteria:
- Any prior systemic therapy for RCC.
- Prior treatment with anti-PD1/L1, anti-CTLA4, VEGFR TKI, or anti-VEGF agents.
NCT05827016
A study for patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplant.
Key Inclusion Criteria:
- Received 3-6 cycles of induction with a PI and IMiD +/- CD38 mAb.
- Underwent single or tandem autologous stem cell transplant (ASCT).
Key Exclusion Criteria:
- Progressive disease or clinical relapse post-ASCT.
- Not responsive to primary induction therapy.
NCT05953337
A study of radioembolization with Eye90 microspheres for patients with unresectable Hepatocellular Carcinoma (HCC).
Key Inclusion Criteria:
- Confirmed HCC (LIRADS 5 or biopsy).
- Up to 3 lesions; at least one ≥ 2 cm and mRECIST measurable.
Key Exclusion Criteria:
- Macrovascular invasion.
- Any extrahepatic disease.
NCT06451614
Eligible for patients with low to intermediate risk prostate cancer undergoing external beam radiotherapy (EBRT).
NCT06586515
For patients with advanced or metastatic solid tumors with a KRAS G12D mutation, including pancreatic, non-small cell lung, and colorectal cancers.
Key Inclusion Criteria:
- Evidence of KRAS G12D mutation in tumor tissue or ctDNA.
- Locally advanced, unresectable, or metastatic solid tumor.
Key Exclusion Criteria:
- Known active CNS metastases or carcinomatous meningitis.
- Other active malignancy, unless in remission with >2 year life expectancy.
NCT06892522
A study for adult patients with newly diagnosed or relapsed/refractory multiple myeloma.
Key Inclusion Criteria:
- Confirmed diagnosis of multiple myeloma (MM) by IMWG criteria.
- Either newly diagnosed or relapsed/refractory MM, depending on the substudy.
Key Exclusion Criteria:
- Known active central nervous system (CNS) involvement of MM.
- Known active infection as outlined in the protocol.
NCT06765109
A study of neladalkib for treatment-naive patients with advanced ALK-positive non-small cell lung cancer (NSCLC).
Key Inclusion Criteria:
- Documented ALK rearrangement via tissue or blood test.
- Locally advanced (not for multimodality treatment) or metastatic NSCLC.
Key Exclusion Criteria:
- Known oncogenic driver alteration other than ALK.
- Symptomatic brain metastases or requiring increasing doses of corticosteroids.
NCT01351545
For patients with hematologic malignancies and other inherited or acquired disorders of the hematopoietic system requiring a cord blood transplant.
Key Inclusion Criteria:
- Diagnosis of a disorder affecting the hematopoietic system (inherited, acquired, or from myeloablative treatment).
Key Exclusion Criteria:
- Receiving only licensed Cord Blood Units (CBUs).
- Enrolled on another IND protocol to access the unlicensed CBU.
NCT05611931
A study of selinexor as maintenance therapy for patients with p53 wild-type, advanced or recurrent endometrial carcinoma.
Key Inclusion Criteria:
- Histologically confirmed EC (endometrioid, serous, undifferentiated, carcinosarcoma) with TP53 wild-type status.
- Confirmed partial or complete response after at least 12 weeks of platinum-based chemotherapy.
Key Exclusion Criteria:
- Histology of uterine sarcoma, clear cell, or small cell carcinoma.
- Stable disease or progression after most recent platinum-based chemotherapy.
NCT04634552
This is a study for participants with relapsed or refractory multiple myeloma.
Key Inclusion Criteria:
- Measurable multiple myeloma per IMWG criteria.
- Received >= 3 prior lines of therapy (most cohorts).
Key Exclusion Criteria:
- Prior CAR-T or T-cell redirection therapy (for Cohorts A/C).
- T-cell redirection therapy within 3 months (for Cohorts B/D/E).
NCT06750094
A study for patients with recurrent, unresectable, or metastatic KRAS/NRAS and BRAF wild-type colorectal cancer who have received prior chemotherapy.
Key Inclusion Criteria:
- KRAS/NRAS and BRAF V600X wild-type status.
- Received 1 prior line of fluoropyrimidine- and oxaliplatin-based therapy for mCRC.
Key Exclusion Criteria:
- Prior treatment with irinotecan, EGFR inhibitors, or MET inhibitors.
- Known dMMR/MSI-H status without prior immunotherapy.
NCT05675449
A study for patients with relapsed or refractory multiple myeloma.
Key Inclusion Criteria:
- Measurable disease by IMWG criteria.
- Part 1: Received 1 to 3 prior lines of therapy.
Key Exclusion Criteria:
- Diagnosis of plasma cell leukemia, smouldering MM, or primary refractory MM.
- Part 1: Prior treatment with a BCMA-directed therapy or carfilzomib.
NCT05438043
A long-term extension study for patients with multiple myeloma or smoldering multiple myeloma who are benefiting from daratumumab treatment in a prior Janssen study.
Key Inclusion Criteria:
- Must be enrolled in and benefiting from a prior Janssen R&D daratumumab study.
- No disease progression or unmanageable toxicity in parent study.
Key Exclusion Criteria:
- Received disallowed therapies between parent study completion and first dose.
- Known allergies/hypersensitivity to daratumumab or combo agents.
NCT06662786
A first-line study for patients with unresectable or metastatic, KRAS/NRAS and BRAF wild-type, left-sided colorectal cancer.
Key Inclusion Criteria:
- KRAS, NRAS, and BRAF wild-type (WT) tumor.
- Unresectable or metastatic left-sided adenocarcinoma of the colon/rectum.
Key Exclusion Criteria:
- Prior treatment with EGFR or MET targeted agents.
- Known dMMR/MSI-H status or HER2-positive/amplified tumor.
NCT06208150
For patients with relapsed or refractory multiple myeloma who have received 1-4 prior lines of therapy, including an anti-CD38 antibody and lenalidomide.
Key Inclusion Criteria:
- Received 1-4 prior lines, including an anti-CD38 antibody and lenalidomide.
- Relapsed or refractory disease.
Key Exclusion Criteria:
- Known active CNS involvement or clinical signs of meningeal involvement.
- Stroke, TIA, or seizure within 6 months.
NCT05663203
A supportive care study for patients with colorectal cancer and their caregivers to manage psychoneurological symptoms.
Key Inclusion Criteria:
- Receiving active chemotherapy.
- Self-reported at least two psychoneurological symptoms.
Key Exclusion Criteria:
- Caregiver has a severe disease (e.g., cancer, heart disease).
NCT07276399
A study for patients with treatment-naive recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC).
Key Inclusion Criteria:
- Recurrent/metastatic HNSCC incurable by local therapies.
- For oropharyngeal primary, must be HPV-negative (p16, HPV DNA, or ISH).
Key Exclusion Criteria:
- Primary tumor site of nasopharynx or unknown primary.
- Untreated brain metastases or known leptomeningeal disease.
NCT06262139
A diagnostic imaging study for patients with high-grade (Gleason score 8-10) prostate cancer.
Key Inclusion Criteria:
- Confirmed Gleason score 8-10 prostate cancer.
- Prior prostate mpMRI and biopsy required.
Key Exclusion Criteria:
- Contraindications for MRI (e.g., pacemakers, cochlear implants).
- Active non-prostate malignancy.
NCT06667908
A study for patients with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC).
Key Inclusion Criteria:
- Locally advanced, unresectable Stage III NSCLC (8th edition).
- At least one target lesion amenable to intratumoral/intranodal injection and IMRT.
Key Exclusion Criteria:
- History of primary immunodeficiency or organ transplant requiring immunosuppression.
- Significant cardiac events or Class III-IV heart failure within 3 months.
NCT07280013
A study of cemsidomide with elranatamab for patients with relapsed or refractory multiple myeloma.
Key Inclusion Criteria:
- Measurable disease by IMWG criteria.
- Received 1-4 prior lines of therapy.
Key Exclusion Criteria:
- Diagnosis of smoldering MM, POEMS, systemic light chain amyloidosis, or MDS.
- No prior BCMA-directed TCE or BCMA-directed CAR-T therapy.
NCT06667076
For patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with common EGFR mutations (Exon 19 deletion or L858R).
Key Inclusion Criteria:
- Documented EGFR mutation (Ex19del or L858R).
- Advanced or metastatic NSCLC not amenable to curative therapy.
Key Exclusion Criteria:
- History of active interstitial lung disease (ILD) or radiation pneumonitis.
- Prior or concurrent second malignancy with interfering natural history or treatment.
NCT02660645
A registry study for patients with suspected or known non-muscle invasive bladder cancer undergoing blue light cystoscopy.
Key Inclusion Criteria:
- Suspected or known non-muscle invasive bladder cancer based on a prior cystoscopy.
Key Exclusion Criteria:
- Porphyria.
- Gross hematuria.
NCT05283720
A study for adult participants with various types of Non-Hodgkin Lymphoma, including Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), and Mantle Cell Lymphoma (MCL).
Key Inclusion Criteria:
- Diagnosis of DLBCL, Follicular Lymphoma (Grade 1-3a), or Mantle Cell Lymphoma.
- Histologically confirmed CD20+ disease.
Key Exclusion Criteria:
- Prior treatment with epcoritamab or any CD3/CD20 bispecific antibody.
- Unresolved toxicities (> Grade 2) from prior therapy (excluding alopecia).
NCT06544265
A study of SynKIR-310 for patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL).
Key Inclusion Criteria:
- Relapsed/refractory disease after at least 2 prior lines of therapy.
- Must have received prior CAR-T or be unwilling/unable to receive it.
Key Exclusion Criteria:
- History or presence of active or clinically relevant primary CNS disorder.
- Known immunodeficiency disease.
NCT05203172
A continuation study for patients with solid tumors who are benefiting from encorafenib and/or binimetinib in a prior clinical trial.
Key Inclusion Criteria:
- Currently receiving treatment in a qualifying encorafenib/binimetinib parent study.
- Deriving clinical benefit from study treatment, per investigator.
NCT06215118
For patients with relapsed or refractory multiple myeloma.
Key Inclusion Criteria:
- Measurable disease by IMWG criteria (e.g., Serum M-protein ≥0.5 g/dL).
- Received 1-4 prior lines of therapy for multiple myeloma.
Key Exclusion Criteria:
- Diagnosis of plasma cell leukemia, smoldering myeloma, or amyloidosis.
- Prior BCMA-directed or CD3 redirecting therapy.
NCT03761108
A study for adult patients with relapsed or refractory multiple myeloma.
Key Inclusion Criteria:
- At least 3 prior lines of therapy including a PI, IMiD, and anti-CD38 antibody.
- Triple-refractory disease to a PI, IMiD, and anti-CD38 antibody (Phase 2).
Key Exclusion Criteria:
- Prior treatment with BCMA-directed bispecific antibodies or BiTEs.
- Known MM brain lesions or meningeal involvement.
NCT04068597
A study for patients with advanced hematological malignancies, including Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia, or High-Risk Myelodysplastic Syndrome.
Key Inclusion Criteria:
- Confirmed relapsed or refractory NHL, MM, or AML.
- Must have previously received standard therapy.
Key Exclusion Criteria:
- QTcF prolongation > 470 msec.
- Anti-cancer drugs within 14 days or 5 half-lives of first dose.
NCT05183932
An observational study for patients with Stage I Non-Small Cell Lung Cancer (NSCLC).
Key Inclusion Criteria:
- Clinical stage I NSCLC (T1 or T2a, N0, M0).
- First primary NSCLC on the ipsilateral side.
Key Exclusion Criteria:
- Synchronous primary lung cancer.
- Low-grade neuroendocrine carcinoma (carcinoid).
NCT06297226
A study of Arlocabtagene Autoleucel for adult participants with relapsed or refractory multiple myeloma.
Key Inclusion Criteria:
- At least 3 prior lines of therapy.
- Prior treatment with an IMiD, PI, anti-CD38 mAb, and anti-BCMA therapy.
Key Exclusion Criteria:
- Prior GPRC5D-directed therapy.
- Active or history of CNS involvement with multiple myeloma.
NCT05253651
A study for patients with HER2-positive, RAS wild-type metastatic colorectal cancer receiving first-line treatment.
Key Inclusion Criteria:
- HER2+ disease confirmed by central lab.
- RAS wild-type (WT) disease.
Key Exclusion Criteria:
- Prior systemic therapy for metastatic/unresectable CRC.
- Previous treatment with any anti-HER2 therapy.
NCT07094204
A study for adults with locally advanced (unresectable) or metastatic solid tumors with specific KRAS mutations or amplifications.
Key Inclusion Criteria:
- KRAS G12V, G12D, G12C, G12R, G12A, G13D mutation or KRAS amplification.
- Received prior standard therapy for advanced disease and progressed or ineligible.
Key Exclusion Criteria:
- Prior treatment with most KRAS targeting agents.
- Symptomatic or untreated CNS metastases or leptomeningeal disease.
NCT06065748
For patients with ER-positive, HER2-negative advanced breast cancer that has become resistant to prior adjuvant endocrine therapy.
Key Inclusion Criteria:
- Locally advanced or metastatic adenocarcinoma of the breast.
- Documented ER-positive, HER2-negative tumor.
Key Exclusion Criteria:
- Prior systemic therapy for locally advanced or metastatic breast cancer.
- Prior treatment with any SERD (e.g., fulvestrant) or novel ER-targeting agents.
NCT06075953
A study for patients with hormone receptor-positive (HR+) Ductal Carcinoma in Situ (DCIS) to evaluate active surveillance with hormonal therapy.
Key Inclusion Criteria:
- Diagnosis of HR+ DCIS (≥50% ER or PR), with or without microinvasion.
- Washout period of 4-6 weeks required for prior endocrine therapy.
Key Exclusion Criteria:
- Diagnosis of invasive carcinoma.
- Co-enrollment in other investigational drug trials.
NCT06615479
A study for adult participants with relapsed or refractory multiple myeloma who have been exposed to lenalidomide.
Key Inclusion Criteria:
- Received 1 to 3 prior lines of therapy for MM.
- Prior exposure to lenalidomide required.
Key Exclusion Criteria:
- Known active or history of CNS involvement.
- Solitary plasmacytomas or non-secretory myeloma without measurable disease.
NCT06562543
A trial for patients with advanced, previously treated, refractory metastatic colorectal cancer.
Key Inclusion Criteria:
- Self-identifies as Black/African American or Hispanic/Latino.
- Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy.
Key Exclusion Criteria:
- Prior treatment with fruquintinib.
- Untreated or unstable brain metastases, or requiring steroids within 4 weeks.
NCT06545955
A study for patients with high-grade, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).
Key Inclusion Criteria:
- High-grade NMIBC with carcinoma in situ (CIS), with or without Ta/T1 disease.
- Unresponsive to at least 2 courses of BCG therapy within the last 12 months.
Key Exclusion Criteria:
- Any evidence of muscle-invasive (T2+) or metastatic bladder cancer.
- Presence of lymphovascular invasion or variant histology (micropapillary, etc.).
NCT06510374
A trial for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC).
Key Inclusion Criteria:
- Histologically confirmed IR NMIBC (e.g., recurrent LG Ta, LG Ta >3cm, multifocal LG Ta, HG Ta ≤3cm, or LG T1).
- Adequate TURBT performed within 60 days prior to randomization.
Key Exclusion Criteria:
- Evidence of muscle invasive or metastatic disease.
- Diagnosis of high-risk NMIBC (e.g., HG T1, recurrent HG Ta, CIS).
NCT04973605
A study for patients with relapsed or refractory multiple myeloma with the t(11;14) translocation.
Key Inclusion Criteria:
- Confirmed t(11;14) translocation by central FISH testing.
- Relapsed or refractory multiple myeloma (R/R MM).
Key Exclusion Criteria:
- Prior treatment with sonrotoclax or other BCL2 inhibitors (e.g., venetoclax).
- Non-secretory MM, solitary plasmacytoma, or active plasma cell leukemia.
NCT06842498
A study for patients with metastatic castration-resistant prostate cancer (mCRPC).
Key Inclusion Criteria:
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Progressed on exactly one prior second-generation ARSI.
Key Exclusion Criteria:
- Small cell, neuroendocrine, or any non-adenocarcinoma histology.
- Prior chemotherapy for mCRPC.
NCT03567889
A study for patients with resectable clinical Stage IIIB, IIIC, or IIID melanoma.
Key Inclusion Criteria:
- Histologically confirmed, surgically resectable Stage IIIB, IIIC, or IIID melanoma.
- At least one injectable lesion ≥10 mm, or multiple injectable lesions aggregating to ≥10 mm.
Key Exclusion Criteria:
- Evidence of distant metastases at screening.
- Uveal or mucosal melanoma.
NCT07100106
For patients with locally advanced or metastatic ER-positive, HER2-negative breast cancer that has progressed after treatment with a CDK4/6 inhibitor.
Key Inclusion Criteria:
- ER-positive and HER2-negative tumor.
- Progression on a prior CDK4/6 inhibitor and endocrine therapy.
Key Exclusion Criteria:
- Prior chemotherapy for metastatic breast cancer.
- More than one line of therapy for locally advanced or metastatic disease.
NCT07213154
A diagnostic study for patients with skin lesions, including suspected or confirmed skin cancers.
Key Inclusion Criteria:
- Patient has one or more skin lesions requiring evaluation.
Key Exclusion Criteria:
- Prior surgery or radiotherapy to the specific lesion area.
NCT06876649
A long-term safety study for patients with Chronic Lymphocytic Leukemia or Non-Hodgkin Lymphoma who previously participated in a clinical trial of pirtobrutinib.
Key Inclusion Criteria:
- Currently participating in an eligible Lilly-sponsored pirtobrutinib clinical study.
NCT06492759
A trial for patients with PD-L1 positive, metastatic triple-negative breast cancer.
Key Inclusion Criteria:
- Biopsy-proven metastatic triple-negative breast cancer (TNBC).
- PD-L1 positive (CPS ≥ 10).
Key Exclusion Criteria:
- Prior chemotherapy or targeted therapy for metastatic disease.
- Prior radiation to metastases targeted for treatment on this study.
NCT07206225
A study for adults with high-risk, non-muscle invasive bladder cancer (NMIBC).
Key Inclusion Criteria:
- Histologically confirmed high-risk NMIBC (CIS +/- T1/Ta, or high-grade T1/Ta).
- Ineligible for, refused, or not a candidate for radical cystectomy.
Key Exclusion Criteria:
- Prior radiation therapy to the bladder.
- Concurrent anti-cancer therapy for NMIBC.
NCT05640999
A study of adjuvant therapy for patients with early-stage, POLE-mutated or p53-wildtype/NSMP endometrial cancer.
Key Inclusion Criteria:
- Histologically confirmed Stage I-III endometrial carcinoma.
- Must have had hysterectomy and bilateral salpingo-oophorectomy.
Key Exclusion Criteria:
- Clinical evidence of distant metastasis.
- Prior neoadjuvant chemotherapy for current diagnosis.
NCT05040360
A study of adjuvant chemotherapy for patients with high-risk, resected pancreatic neuroendocrine tumors (pNETs).
Key Inclusion Criteria:
- Histologically confirmed well-differentiated pNET.
- Ki-67 between 3% and 55%.
Key Exclusion Criteria:
- Unresected or unablated metastatic disease.
- Prior neoadjuvant therapy for pNET.
NCT01120353
An observational study for long-term survivors of various childhood cancers, including leukemia, lymphoma, CNS tumors, and bone tumors.
Key Inclusion Criteria:
- Diagnosed with an eligible cancer before age 21 between 1970-1999.
- At least 5-year survival from initial diagnosis.
Key Exclusion Criteria:
- Diagnosis of specific non-malignant tumors (e.g., LCH, meningioma) treated with chemo/radiation.
NCT06538480
A study for adult patients with Recurrent Respiratory Papillomatosis (RRP).
Key Inclusion Criteria:
- Histologically confirmed recurrent respiratory papillomatosis.
- Cohort 1: Must be treatment-naïve to Zopa.
Key Exclusion Criteria:
- Systemic corticosteroids >10mg prednisone equivalent within 14 days.
- Other immunosuppressive medications within 14 days.
NCT06581406
A study for adult patients with metastatic uveal melanoma who have not previously received immune checkpoint inhibitor therapy.
Key Inclusion Criteria:
- Confirmed metastatic uveal melanoma not amenable to surgical resection.
- At least one measurable and injectable tumor (≥ 1 cm).
Key Exclusion Criteria:
- Any prior immune checkpoint inhibitor (ICI) therapy.
- Any central nervous system (CNS) involvement of melanoma.
NCT06356129
A study for patients with previously untreated, high-risk large B-cell lymphoma (LBCL).
Key Inclusion Criteria:
- Histologically confirmed de novo LBCL (DLBCL, HGBL, THRLBCL, EBV+ DLBCL).
- High-risk disease: IPI ≥ 3, or IPI 1-2 with LDH >1.3x ULN or bulky disease (≥7cm).
Key Exclusion Criteria:
- Specific lymphoma subtypes (PMBCL, transformed indolent lymphoma, Burkitt, etc.).
- Documented or suspected CNS involvement by lymphoma.
NCT06679985
A trial for patients with unresectable, locally advanced, or metastatic Hepatocellular Carcinoma (HCC).
Key Inclusion Criteria:
- Unresectable, locally advanced, or metastatic HCC.
- Not amenable to curative surgery/locoregional therapy or has progressed after.
Key Exclusion Criteria:
- Any prior systemic therapy for HCC.
- Prior anti-IL-27 antibody or targeted therapy.
NCT06827236
For patients with locally advanced, unresectable, or metastatic breast cancer, including various HER2 expression levels and triple-negative breast cancer.
Key Inclusion Criteria:
- Locally advanced, unresectable, or metastatic breast cancer.
- Confirmed HER2 status (low, ultralow, null, positive) or TNBC.
Key Exclusion Criteria:
- Prior topoisomerase I inhibitors, including ADCs like trastuzumab deruxtecan.
- History of or current non-infectious interstitial lung disease (ILD)/pneumonitis.
NCT02523014
A study for patients with progressive or recurrent intracranial meningioma with specific genetic mutations (SMO, PTCH1, NF2, AKT1, PIK3CA, PTEN, or CDK pathway).
Key Inclusion Criteria:
- Histologically proven, progressive or residual intracranial meningioma.
- Tumor must have SMO, PTCH1, NF2, AKT1, PIK3CA, PTEN, or CDK pathway alteration.
Key Exclusion Criteria:
- Metastatic (extracranial) meningiomas; spinal meningiomas are allowed.
- Chemotherapy or other investigational agents within 28 days.
NCT05976763
A study of continuous versus intermittent zanubrutinib for older patients with previously untreated Mantle Cell Lymphoma.
Key Inclusion Criteria:
- Histologically confirmed MCL with cyclin D1 expression or t(11;14).
- Measurable disease: >=1 nodal lesion >1.5 cm or >=1 extranodal lesion >1 cm.
Key Exclusion Criteria:
- Prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody.
- Clinically significant cardiovascular disease (e.g., unstable angina, NYHA Class III/IV CHF).
NCT05320198
A study for patients with Myelofibrosis (MF) or Myelodysplastic Syndrome (MDS) who also have anemia.
Key Inclusion Criteria:
- Diagnosis of Myelofibrosis (MF) or lower-risk Myelodysplastic Syndrome (MDS).
- MF: DIPSS score of Intermediate-1 risk or higher.
Key Exclusion Criteria:
- MDS cohort: Prior hypomethylating agents or AML-like chemotherapy.
- MDS cohort: Secondary MDS or peripheral blasts ≥5%.
NCT05673148
A study for patients with limited metastatic colorectal cancer.
Key Inclusion Criteria:
- 4 or fewer sites of metastatic disease.
- No known MSI or BRAF V600E mutation.
NCT06369285
For patients with HR-positive, HER2-negative recurrent or metastatic breast cancer.
Key Inclusion Criteria:
- HR-positive and HER2-negative breast cancer.
- Recurrent or metastatic disease not amenable to curative therapy.
Key Exclusion Criteria:
- Prior chemotherapy in the recurrent or metastatic setting.
- Prior treatment with an AURKA inhibitor (including alisertib).
NCT04221542
A Phase 1 study for patients with metastatic castration-resistant prostate cancer (mCRPC).
Key Inclusion Criteria:
- Evidence of progressive disease by PCWG3 criteria.
- Specific prior treatment history required, which varies by study part.
Key Exclusion Criteria:
- Histology other than adenocarcinoma (e.g., pure small cell, neuroendocrine).
- Untreated CNS metastases or leptomeningeal disease.
NCT06661720
A study of tivozanib plus pembrolizumab versus pembrolizumab alone for patients with high-risk renal cell carcinoma (RCC) after surgery.
Key Inclusion Criteria:
- Histologically confirmed RCC with a clear cell component.
- High-risk disease (pT2 G4, pT3, pT4, or N+) or M1 NED status post-metastasectomy.
Key Exclusion Criteria:
- Prior systemic treatment for RCC.
- Active autoimmune disease requiring systemic treatment in the past 2 years.
NCT06674863
A study for Black or African American men with localized or oligometastatic prostate cancer who have completed primary treatment.
Key Inclusion Criteria:
- Must be Black or African American men.
- Disease-free after primary treatment for prostate cancer.
Key Exclusion Criteria:
- Recurrent prostate cancer after primary treatment.
- Active second malignancy requiring treatment.
NCT05131022
A study for adult patients with various relapsed or refractory B-cell malignancies, including CLL, SLL, DLBCL, FL, MCL, MZL, WM, and CNS lymphomas.
Key Inclusion Criteria:
- Histologically confirmed relapsed/refractory B-cell malignancy (CLL, SLL, DLBCL, etc.).
- Must meet cohort-specific prior therapy requirements (e.g., prior BTKi, BCL-2i).
Key Exclusion Criteria:
- Prior treatment with a BTK degrader.
- Prohibited washout periods for prior therapies (chemo, radiation, mAb, CAR-T).
NCT05479812
A study for patients with selected advanced or metastatic solid tumors, including melanoma, renal cell carcinoma, cutaneous squamous cell carcinoma, and non-small cell lung cancer.
Key Inclusion Criteria:
- Histologically confirmed advanced/metastatic solid tumor for which a CPI is indicated.
- Expansion cohorts: RCC, melanoma, cSCC, or PD-L1+ NSCLC.
Key Exclusion Criteria:
- Prior IL-2-directed therapy.
- Symptomatic brain metastases requiring steroids.
NCT03715933
A study for patients with locally advanced or metastatic solid tumors, including a specific cohort for Ewing Sarcoma.
Key Inclusion Criteria:
- Locally advanced, metastatic, or unresectable Ewing sarcoma or colorectal adenocarcinoma.
- Ewing sarcoma cohort: Must have a classical fusion.
Key Exclusion Criteria:
- Prior treatment with a DR5 agonist.
- Symptomatic or active CNS tumors, leptomeningeal disease, or CNS metastases.
NCT06163534
A study for patients with metastatic or unresectable recurrent Head & Neck Squamous Cell Carcinoma (HNSCC).
Key Inclusion Criteria:
- Metastatic or unresectable, recurrent HNSCC unsuitable for local therapies.
- Intended for 1L anti-PD-1/PD-L1 monotherapy or combination therapy.
Key Exclusion Criteria:
- Non-squamous histologies (e.g., nasopharynx, salivary gland).
- PD-L1 negative tumors (CPS <1).
NCT06991556
A study for adult male patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC).
Key Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate.
- High-volume mHSPC (≥1 visceral lesion or ≥4 bone lesions).
Key Exclusion Criteria:
- Prior second-generation ARPI for metastatic disease.
- Mixed histology (e.g., neuroendocrine features).
NCT05201781
A long-term follow-up study for patients with multiple myeloma who were previously treated with ciltacabtagene autoleucel.
Key Inclusion Criteria:
- Received at least one dose of cilta-cel in a prior Company-sponsored study.
NCT06807437
For patients with pancreatic cancer or pre-malignant pancreatic lesions scheduled for a distal pancreatectomy.
Key Inclusion Criteria:
- Elective distal pancreatectomy planned within 60 days of registration.
Key Exclusion Criteria:
- Requires modified Appleby procedure or multivisceral resection.
- Requires tumor enucleation.
NCT04892173
A study for elderly patients with locally advanced squamous cell carcinoma of the head and neck (HNSCC) who are ineligible for platinum-based chemotherapy.
Key Inclusion Criteria:
- Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or supraglottic larynx.
- Clinical stage T3-4 NX or T2 N2-3 (AJCC 8th ed.).
Key Exclusion Criteria:
- Metastatic (M1) disease or stage T1-2 N0 / T2 N1.
- Carcinoma of nasopharynx, paranasal sinus, salivary/thyroid gland, or unknown primary.
NCT04662580
A study of ARX517, alone or in combination with other therapies, for patients with metastatic prostate cancer.
Key Inclusion Criteria:
- Histologically confirmed prostate adenocarcinoma.
- At least one PSMA-positive metastatic lesion and no PSMA-negative lesions.
Key Exclusion Criteria:
- Prior apalutamide, enzalutamide, darolutamide, or AAP (mCRPC cohorts).
- More than 1 prior taxane regimen (for some cohorts).
NCT03851445
A master screening protocol for patients with previously-treated, Stage IV or recurrent non-small cell lung cancer (NSCLC).
Key Inclusion Criteria:
- Stage IV or recurrent NSCLC.
- Must have progressed on at least one prior line of systemic therapy.
Key Exclusion Criteria:
- Known EGFR/ALK/ROS1/BRAF mutations without progression on all standard targeted therapies.
- Tumor tissue from bone biopsies is not acceptable for submission.
NCT05429632
A study of mocravimod for adult patients with Acute Myeloid Leukemia (AML) who are undergoing an allogeneic hematopoietic cell transplant (HCT).
Key Inclusion Criteria:
- ELN high/intermediate-risk AML in CR1, or any-risk AML in CR2/CRi.
- Planned allogeneic HCT.
Key Exclusion Criteria:
- Prohibited GvHD prophylaxis: CsA, ATG, alemtuzumab, or abatacept.
- History, diagnosis, or screening presence of macular edema or uveitis.
NCT07037758
A study for patients with extensive stage small cell lung cancer (ES-SCLC) that has progressed or recurred after prior therapy.
Key Inclusion Criteria:
- Progressed/recurrent ES-SCLC after at least 1 prior line of therapy.
- At least one measurable lesion per RECIST 1.1, not previously irradiated.
Key Exclusion Criteria:
- Symptomatic central nervous system (CNS) metastases.
- Prior therapy with any DLL3-directed agent (including tarlatamab).
NCT06578247
A study for adult patients with newly diagnosed FLT3-ITD negative Acute Myeloid Leukemia (AML).
Key Inclusion Criteria:
- Newly diagnosed, morphologically documented primary AML (WHO 2016).
- Candidate for standard '7+3' induction chemotherapy regimen.
Key Exclusion Criteria:
- FLT3-ITD mutation positive (≥5% VAF).
- Diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL positive leukemia.
NCT06624085
For patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL).
Key Inclusion Criteria:
- Histologically confirmed DLBCL, not otherwise specified (NOS).
- Relapsed or refractory disease.
Key Exclusion Criteria:
- High-grade B-cell lymphoma (double/triple hit) or primary mediastinal B-cell lymphoma.
- History of transformation from indolent disease to DLBCL.
NCT06616584
A study for patients with Stage IV or recurrent non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy and immunotherapy.
Key Inclusion Criteria:
- Exactly one prior line of anti-PD-1/PD-L1 therapy for advanced disease.
- Progression >84 days after starting prior immunotherapy.
Key Exclusion Criteria:
- Prior treatment with docetaxel for this disease.
- Active autoimmune disease requiring systemic treatment in the last 2 years.
NCT05642572
A study for patients with EGFR-mutant, MET-amplified Stage IV or recurrent non-small cell lung cancer.
Key Inclusion Criteria:
- NSCLC with a sensitizing EGFR mutation.
- Progression on most recent therapy of osimertinib.
Key Exclusion Criteria:
- Prior treatment with an anti-VEGF, VEGFR, or MET inhibitor.
- Anti-cancer drugs (except osimertinib) within 21 days of randomization.
NCT03802695
A study for patients with hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype acute leukemia, and myelodysplastic syndromes (MDS).
Key Inclusion Criteria:
- Diagnosis of AML, ALL, MPAL, or high/very high-risk MDS.
- In complete remission (CR) or with ≤10% bone marrow blasts.
Key Exclusion Criteria:
- Prior allogeneic hematopoietic cell transplant (alloHCT).
- Currently receiving corticosteroids or other immunosuppressive therapy.
NCT07114601
A study for patients with GRPR-positive advanced solid tumors, including breast, colorectal, prostate, and endometrial cancer.
Key Inclusion Criteria:
- Locally advanced, unresectable, or metastatic solid tumor.
- GRPR-positive disease confirmed by imaging.
Key Exclusion Criteria:
- Prior radiopharmaceutical therapy (except 177Lu-PSMA-617 for mCRPC).
- Prior EBRT to >25% of bone marrow.
NCT06876662
A study for patients with previously treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL).
Key Inclusion Criteria:
- Currently enrolled and active in the originator study, LOXO-BTK-18001.
Key Exclusion Criteria:
- Previously participated in the Phase 1b cohort of study LOXO-BTK-18001.
NCT06001788
A study for patients with relapsed or refractory Acute Myeloid Leukemia (AML) with a KMT2A rearrangement or NPM1 mutation.
Key Inclusion Criteria:
- Diagnosed with relapsed/refractory AML.
- Documented NPM1 mutation or KMT2A rearrangement.
Key Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia (APL) or blast crisis CML.
- Clinically active central nervous system (CNS) leukemia.
NCT05812807
For patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after neoadjuvant chemotherapy plus pembrolizumab.
NCT06377852
A study for older patients (age 65+) with HR+/HER2- metastatic breast cancer.
Key Inclusion Criteria:
- HR+/HER2- metastatic breast cancer.
- Candidate for 1st use of palbociclib or ribociclib in the metastatic setting.
Key Exclusion Criteria:
- Prior CDK4/6 inhibitor for metastatic breast cancer.
- Prior CDK4/6 inhibitor in neo/adjuvant setting within 12 months.
NCT05879926
For premenopausal women with early-stage, pN0-1, ER-positive, HER2-negative breast cancer and an Oncotype Recurrence Score of 25 or less.
Key Inclusion Criteria:
- Premenopausal women with pathologic stage pT1-3 and pN0-1 disease.
- Tumor must be ER and/or PgR-positive and HER2-negative.
Key Exclusion Criteria:
- Definitive evidence of metastatic disease.
- Pathologic T4 tumors, including inflammatory breast cancer.
NCT06619236
A study for patients with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.
Key Inclusion Criteria:
- High-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
- Platinum-resistant disease (progressed >91 and ≤183 days after last platinum).
Key Exclusion Criteria:
- Prior ADC with a topoisomerase 1 inhibitor.
- Primary platinum-refractory disease (progressed ≤91 days after 1st line platinum).
NCT06615635
A study for immunocompromised patients with cutaneous squamous cell carcinoma (SCC).
Key Inclusion Criteria:
- Immunocompromised due to primary or secondary immunodeficiencies.
- Single target lesion.
Key Exclusion Criteria:
- Distant or nodal metastatic disease (N+ or M1).
- T4 stage disease.
NCT06698458
A study for patients with newly diagnosed, locally advanced or metastatic pancreatic adenocarcinoma.
Key Inclusion Criteria:
- Newly diagnosed locally advanced inoperable or metastatic pancreatic adenocarcinoma.
- Target lesion is technically amenable for Alpha DaRT implantation.
Key Exclusion Criteria:
- Borderline resectable or operable disease (locally advanced cohort only).
- Prior treatment for pancreatic cancer.
NCT06748222
A study for survivors of non-metastatic (Stage 0-III) breast cancer diagnosed at or before age 50 with elevated depressive symptoms.
Key Inclusion Criteria:
- Diagnosed with Stage 0-III non-metastatic breast cancer.
- Diagnosed at age 50 or younger.
Key Exclusion Criteria:
- Recurrent or metastatic breast cancer.
- History of other cancers (exceptions for non-melanoma skin/in situ cervical).
NCT04852887
For patients with Stage I, hormone-sensitive, HER2-negative breast cancer and a low Oncotype Recurrence Score (≤18).
Key Inclusion Criteria:
- Pathologic stage pT1 (≤ 2 cm), pN0.
- ER/PgR positive (≥1%) and HER2-negative.
Key Exclusion Criteria:
- Definitive evidence of metastatic disease.
- pT1mi, pT2-pT4 tumors or any pN+ disease (including pN0(i+)).
NCT04901702
A study for children and young adults with various recurrent or refractory solid tumors, including Ewing sarcoma.
NCT06226571
A study for patients with newly diagnosed acute myeloid leukemia (AML) with KMT2A, NPM1, or NUP98 gene alterations.
Key Inclusion Criteria:
- KMT2Ar, NPM1c, or NUP98r mutations required.
- Previously untreated (newly diagnosed) AML.
Key Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia (APL).
- Clinically active central nervous system (CNS) leukemia.
NCT05323253
A study for patients with recurrent cutaneous Squamous Cell Carcinoma (SCC) who have failed prior standard therapy and are not candidates for surgery or standard radiation.
Key Inclusion Criteria:
- Recurrent cutaneous SCC after failure of at least one line of standard therapy.
- Not a candidate for surgery or standard radiation therapy.
Key Exclusion Criteria:
- Distant or nodal metastatic disease (N+ or M1).
- T4 disease or perineural spread.
NCT05696626
A study for patients with locally advanced or metastatic ER+/HER2- breast cancer with a documented ESR1 mutation.
Key Inclusion Criteria:
- Documented ESR1 mutation in ctDNA or tissue.
- Progression on first-line AI + palbociclib or ribociclib for metastatic disease.
Key Exclusion Criteria:
- Prior progression on abemaciclib, fulvestrant, or other SERD.
- Visceral crisis requiring immediate chemotherapy.
NCT00900198
A tissue procurement study for adult and pediatric patients with various cancers, including solid tumors and hematologic malignancies like lymphomas, multiple myeloma, and myelodysplastic syndrome.
Key Inclusion Criteria:
- Newly diagnosed, untreated malignancy.
- Recurrent or progressing malignancy after prior treatment.
Key Exclusion Criteria:
- Cancer-like syndromes (e.g., systemic mastocytosis, MGUS).
- Benign tumors, carcinoma in situ, or complete response (CR).
NCT05098132
A study for patients with previously untreated, advanced, PD-L1 negative, non-squamous non-small cell lung cancer (NSCLC).
Key Inclusion Criteria:
- Stage IV or Stage IIIB/IIIC NSCLC, not a candidate for definitive treatment.
- Non-squamous (NSQ) histology.
Key Exclusion Criteria:
- Prior immune checkpoint inhibitor therapy.
- Tumor with small cell, neuroendocrine, or sarcomatoid components.
NCT03191149
A study of osimertinib for patients with advanced or recurrent non-small cell lung cancer (NSCLC) that has an EGFR exon 20 insertion mutation.
Key Inclusion Criteria:
- Advanced (Stage IIIB/IV) or recurrent NSCLC.
- Confirmed EGFR exon 20 insertion mutation.
Key Exclusion Criteria:
- Prior treatment with osimertinib.
- Immunotherapy (PD-1/PD-L1/CTLA-4 inhibitors) within 6 months.
NCT07087054
A study for adults with carcinoid syndrome caused by well-differentiated neuroendocrine tumors (NETs).
Key Inclusion Criteria:
- Histologically confirmed, well-differentiated, locally advanced or metastatic NET.
- Documented carcinoid syndrome requiring medical therapy.
Key Exclusion Criteria:
- Requires second-line treatments (e.g., telotristat) for carcinoid syndrome.
- Prior non-response to somatostatin agonists.
NCT05143996
A study for patients with relapsed or refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
Key Inclusion Criteria:
- Progressed, recurred, or intolerant of available approved therapies.
- WBC count < 20,000/uL at time of first dose.
Key Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia (APL).
- Active central nervous system (CNS) leukemia.
NCT06007690
A trial for patients with primary indeterminate lesions or small choroidal melanoma.
Key Inclusion Criteria:
- No evidence of metastatic disease.
- Treatment naive for IL/CM (prior PDT may be allowed).
Key Exclusion Criteria:
- Active ocular infection or disease.
- Known contraindications or sensitivities to study drug or laser.
NCT06792552
A study for patients with advanced solid tumors, with specific cohorts for ovarian cancer, renal cell carcinoma (RCC), uterine serous carcinoma (USC), and non-small cell lung cancer (NSCLC).
Key Inclusion Criteria:
- Part 2: Specific cohorts for ovarian, RCC, USC, or NSCLC.
- NSCLC cohort: Must have CDH6 expression.
Key Exclusion Criteria:
- Prior CDH6-targeted agents or ADCs with a topoisomerase I inhibitor payload.
- Symptomatic or unstable CNS metastases.
NCT07101445
A study for patients with multiple myeloma undergoing stem cell mobilization to evaluate premedication regimens for preventing reactions to motixafortide.
Key Inclusion Criteria:
- Eligible for hematopoietic stem cell mobilization and autologous HSCT.
- Females of reproductive potential must use effective contraception.
Key Exclusion Criteria:
- Prior autologous or allogeneic hematopoietic cell transplantation.
- History of serious systemic reaction to motixafortide.
NCT06072612
A study for patients with advanced, metastatic, or locally recurrent breast cancer who have failed prior therapies.
Key Inclusion Criteria:
- Locally recurrent unresectable or metastatic breast cancer.
- Failed prior standard therapies based on subtype (HER2, ER/PR, TNBC).
Key Exclusion Criteria:
- Prior Grade ≥3 toxicity to checkpoint inhibitor (CPI) therapy.
- Active autoimmune disease requiring systemic treatment in the past year.
NCT06238479
A study for patients with various recurrent, advanced, or metastatic solid tumors.
Key Inclusion Criteria:
- Must have a specified solid tumor type per cohort (urothelial, TNBC, NSCLC, etc.).
- Received all standard therapies or no standard therapy exists (most cohorts).
Key Exclusion Criteria:
- Known or suspected uncontrolled CNS metastases.
- History of Grade ≥3 skin toxicity from prior enfortumab vedotin.
NCT05552469
A study for adult patients with myeloid diseases, including lower-risk myelodysplastic syndromes (MDS), lower-risk chronic myelomonocytic leukemia (CMML), and high-risk clonal cytopenia of undetermined significance (HR CCUS).
Key Inclusion Criteria:
- Diagnosis of LR MDS, LR CMML, or HR-CCUS.
- Dose optimization cohorts: Failed prior therapy (e.g., ESAs, luspatercept, HMAs, lenalidomide).
Key Exclusion Criteria:
- Prior treatment with NLRP3 inflammasome or IL-1 pathway inhibitors (e.g., canakinumab, anakinra).
- Prior cytotoxic chemotherapy for MDS (applies to specific dose expansion cohort).
NCT06190951
A study for adult patients with resectable Stage III or Stage IV melanoma.
Key Inclusion Criteria:
- Histologically confirmed, resectable cutaneous melanoma, Stage III (B/C/D) or Stage IV (M1a/b/c).
- Candidate for complete surgical resection with curative intent.
Key Exclusion Criteria:
- No prior systemic anti-cancer therapy for melanoma.
- Primary uveal melanoma.
NCT06287775
A study for patients with extensive-stage small cell lung cancer (SCLC) who have completed initial chemoimmunotherapy.
Key Inclusion Criteria:
- Received 4-6 cycles of platinum-etoposide + ICI (atezolizumab/durvalumab).
- Radiographic response or stable disease after initial chemoimmunotherapy.
Key Exclusion Criteria:
- Received prior maintenance ICI therapy before Cycle 1, Day 1.
- Active, uncontrolled autoimmune disease (some exceptions apply).
NCT04960579
A study of P-BCMA-ALLO1 allogeneic CAR-T cells for patients with relapsed or refractory multiple myeloma.
Key Inclusion Criteria:
- Relapsed/refractory MM after proteasome inhibitor, IMiD, and anti-CD38 therapy.
- Measurable disease required.
Key Exclusion Criteria:
- CNS metastases or symptomatic CNS involvement.
- Prior allogeneic cellular therapy, gene therapy, or allogeneic SCT.
NCT06072781
A study for patients with recurrent low-grade serous ovarian, fallopian, or peritoneal cancer.
Key Inclusion Criteria:
- Documented KRAS mutational status.
- Progression after at least one prior systemic therapy for metastatic disease.
Key Exclusion Criteria:
- Co-existing high-grade serous or mixed histology.
- Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
NCT05024929
An observational study for patients with metastatic differentiated thyroid cancer (DTC) to assess if targeted therapy increases radioactive iodine (RAI) uptake.
Key Inclusion Criteria:
- Confirmed NTRK/RET/ALK fusion, BRAF V600 mutation, or other targetable alteration.
- Anatomically evaluable disease on chest CT within 180 days of enrollment.
Key Exclusion Criteria:
- Prior oncogene-specific targeted therapy (some exceptions apply).
- Pregnant or breastfeeding.
NCT04970056
An observational study for individuals at high risk for pancreatic cancer due to family history, genetic predisposition, or pancreatic cysts.
Key Inclusion Criteria:
- Meets criteria for high-risk cohorts based on family history, genetic variants, or personal history of PDAC/cysts.
- Known pathogenic/likely pathogenic germline variant (e.g., BRCA1/2, PALB2, ATM, CDKN2A, STK11, PRSS1).
NCT06205485
A study of neoadjuvant chemotherapy versus chemoradiotherapy for patients with early-stage rectal cancer.
Key Inclusion Criteria:
- MRI stage cT1 (ineligible for transanal surgery) or cT2-T3a.
- cN0 and M0 stage (no nodal or distant metastasis).
Key Exclusion Criteria:
- High-risk histology: poorly differentiated, mucinous, or signet ring.
- Visible pelvic sidewall nodes or unequivocal nodal disease on MRI.
NCT03488693
A study of regional radiotherapy for patients with biomarker low-risk, node-positive or T3N0 breast cancer.
Key Inclusion Criteria:
- ER+ (≥1%), HER2-negative disease.
- Oncotype DX recurrence score ≤25.
Key Exclusion Criteria:
- pT3N1 or pT4 disease.
- Nodal disease limited to isolated tumor cells (pN0i+).
NCT03550391
A study for patients with 5 or more brain metastases from a non-hematopoietic malignancy.
Key Inclusion Criteria:
- 5 to 15 brain metastases on MRI.
- Pathologically confirmed non-hematopoietic malignancy.
Key Exclusion Criteria:
- Prior cranial radiation therapy.
- Primary germ cell tumor, small cell carcinoma, or lymphoma.
NCT04970901
A study for patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL).
Key Inclusion Criteria:
- Relapsed or refractory B-NHL with specific eligible histologies (DLBCL, FL, etc.).
- At least 2 prior systemic regimens for Part 1; at least 1 for Part 2.
Key Exclusion Criteria:
- Prior treatment with loncastuximab tesirine.
- Prior treatment with polatuzumab, glofitamab, or mosunetuzumab (arm-dependent).
NCT04569747
A study for patients with anatomic Stage I, hormone receptor-positive (HR+), and HER2-positive breast cancer.
Key Inclusion Criteria:
- Anatomic Stage I (T1, N0/N1mi) invasive breast carcinoma.
- Hormone receptor positive (ER≥10% or PR≥10%) and HER2-positive.
Key Exclusion Criteria:
- Prior neoadjuvant or adjuvant chemotherapy for this breast cancer.
- Locally advanced tumors (e.g., fixed to chest wall, inflammatory changes).
NCT05451004
A study for patients with lateralized oropharyngeal cancer.
Key Inclusion Criteria:
- Pathologically proven lateralized oropharyngeal cancer, not crossing midline.
- Clinical stage T1-3, M0.
Key Exclusion Criteria:
- Previous head and neck cancer or multiple synchronous primary H&N cancers.
- Previous induction or neo-adjuvant chemotherapy.
NCT04752722
A study for patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) who are BCG-unresponsive, BCG-naïve, or have received incomplete BCG treatment.
Key Inclusion Criteria:
- High-risk NMIBC with CIS; must be BCG-unresponsive, BCG-naïve, or have incomplete BCG.
- BCG-unresponsive high-grade Ta/T1 papillary disease without CIS also eligible.
Key Exclusion Criteria:
- Evidence of metastatic disease.
- History of partial cystectomy.
NCT07155317
A study for patients with unresectable or metastatic (Stage IV) cutaneous, acral, or mucosal melanoma.
Key Inclusion Criteria:
- Stage IV unresectable cutaneous, acral, or mucosal melanoma.
- Asymptomatic, non-hemorrhagic brain metastases < 2 cm are allowed.
Key Exclusion Criteria:
- Uveal melanoma.
- Active leptomeningeal disease.
NCT06127407
A study of ivosidenib for patients with locally advanced or metastatic conventional chondrosarcoma with a documented IDH1 mutation.
Key Inclusion Criteria:
- Documented IDH1 gene mutation (R132C/L/G/H/S variants).
- Locally advanced or metastatic conventional chondrosarcoma (Grades 1, 2, or 3).
Key Exclusion Criteria:
- Prior therapy with an IDH1 inhibitor.
- Symptomatic brain metastases requiring >10 mg/day prednisone.
NCT05624996
For patients with locally-advanced, inoperable Stage IIB-III non-small cell lung cancer (NSCLC).
Key Inclusion Criteria:
- Pathologically proven, inoperable Stage IIB or III, node-positive NSCLC.
- Known PD-L1 status required prior to registration.
Key Exclusion Criteria:
- Prior radiotherapy to the study cancer.
- Patients with T3-4N0 or T0N1-3 disease.
NCT06008730
A study of proton beam radiation therapy for patients with resected N2 non-small cell lung cancer (NSCLC).
Key Inclusion Criteria:
- Pathologically confirmed pN2 disease after resection.
- Received pre-operative systemic therapy followed by complete surgical resection.
Key Exclusion Criteria:
- Stage IV (metastatic) disease.
- Incomplete (R1 or R2) surgical resection.
NCT06500455
A study for patients with select solid tumors (NSCLC, melanoma, breast, renal, GI) that have metastasized to the brain.
Key Inclusion Criteria:
- Histologically confirmed NSCLC, melanoma, breast, renal cell, or GI cancer.
- 1 to 8 total intact brain metastases.
Key Exclusion Criteria:
- Prior radiotherapy to the brain (WBRT, SRS, FSRS, PCI).
- Known leptomeningeal disease (LMD).
NCT06745024
A study for patients with high-risk, asymptomatic bone metastases from any solid tumor.
Key Inclusion Criteria:
- Polymetastatic disease (>5 systemic metastatic sites).
- At least one high-risk, asymptomatic bone metastasis (BPI < 5).
Key Exclusion Criteria:
- Previous radiotherapy to the intended enrolled sites of disease.
- Epidural spinal cord compression (ESCC) ≥ grade 1c at enrolled sites.
NCT04804644
A study for patients with small cell lung cancer (SCLC) that has metastasized to the brain.
Key Inclusion Criteria:
- Brain metastases ≤ 4 cm in largest diameter.
- Total intracranial tumor volume ≤ 30 cm³.
Key Exclusion Criteria:
- Prior radiotherapy to the brain (SRS, WBRT, or PCI).
- Definitive leptomeningeal metastases.
NCT05053152
A study for patients with oligometastatic, castration-sensitive prostate cancer that has recurred after initial treatment.
Key Inclusion Criteria:
- 1-5 oligometastatic lesions on fluciclovine or PSMA PET.
- Prior curative-intent radiation or radical prostatectomy for prostate cancer.
Key Exclusion Criteria:
- Spinal cord compression, brain, or visceral metastases (lung mets allowed).
- Prior chemotherapy for prostate cancer or bilateral orchiectomy.
NCT05050084
A study for patients with unfavorable intermediate-risk prostate adenocarcinoma, using a genomic risk score to guide treatment intensity.
Key Inclusion Criteria:
- Unfavorable intermediate risk prostate cancer by NCCN criteria.
- At least one intermediate risk factor (PSA 10-20, T2b-c, or Gleason 7).
Key Exclusion Criteria:
- Definitive evidence of metastatic disease (M1).
- Any high-risk features (Gleason 8-10, PSA > 20, cT3-4).
NCT03186898
A study for patients with unresectable or recurrent hepatocellular carcinoma (liver cancer).
Key Inclusion Criteria:
- Unresectable or locally recurrent hepatocellular carcinoma (HCC).
- Child-Turcotte-Pugh (CTP) score A or B7.
Key Exclusion Criteria:
- Any extrahepatic metastatic disease.
- Prior radiotherapy to the liver region, including Y90.
NCT05946213
A study for patients with high-risk, non-metastatic prostate adenocarcinoma (Stage III-IVA).
Key Inclusion Criteria:
- High-risk disease: cT3a-T3b, PSA > 20, Gleason 8-10, or pelvic node positive.
- Prostate gland volume < 100 cc prior to ADT.
Key Exclusion Criteria:
- Distant metastatic disease (M1a, M1b, or M1c).
- cT4 disease by imaging or digital rectal exam.
NCT03180268
For patients with newly diagnosed Grade II meningioma that has been completely removed by surgery.
Key Inclusion Criteria:
- Newly diagnosed, unifocal, intracranial WHO grade II meningioma.
- Gross total resection (GTR) confirmed by modified Simpson grade 1-3 and post-op MRI.
Key Exclusion Criteria:
- Optic nerve sheath, spinal, extracranial, or multiple meningiomas.
- Definitive evidence of metastatic meningioma.
NCT04134260
For patients with node-positive prostate adenocarcinoma who have undergone a radical prostatectomy.
Key Inclusion Criteria:
- Pathologically node-positive disease post-prostatectomy or at recurrence.
- Must have undergone radical prostatectomy.
Key Exclusion Criteria:
- Radiologic evidence of distant metastatic disease (M1a, M1b, or M1c).
- Prior systemic chemotherapy for prostate cancer.
NCT05408845
A study of HER2-targeted therapies for patients with recurrent, metastatic, or unresectable HER2-expressing salivary gland cancers.
Key Inclusion Criteria:
- HER2-positive (IHC 3+, FISH amp) or HER2-low (IHC 1+, or 2+/FISH non-amp).
- Unresectable, recurrent, or metastatic disease.
Key Exclusion Criteria:
- Prior systemic therapy for metastatic disease (HER2-positive cohort).
- Prior HER2-directed therapy for metastatic disease (HER2-low cohort).
NCT04895436
A study for adult patients with recurring Chronic Lymphocytic Leukemia (CLL) who were previously treated with a venetoclax-based regimen.
Key Inclusion Criteria:
- Completed 1L fixed-duration venetoclax + anti-CD20 antibody regimen.
- Achieved CR, CRi, PR, or nPR to prior 1L venetoclax regimen.
Key Exclusion Criteria:
- Any intervening CLL therapy after 1L venetoclax regimen.
NCT06657144
A study for patients with advanced or metastatic solid tumors, including specific cohorts for gastric, gastroesophageal junction (GEJ), esophageal, and colorectal cancers.
Key Inclusion Criteria:
- Cohort A: HER2-negative, MSS/pMMR Gastric, GEJ, or Esophageal Adenocarcinoma.
- Cohort B/C: Unresectable, locally advanced or metastatic ESCC.
Key Exclusion Criteria:
- Symptomatic or untreated CNS metastases.
- Prior exposure to an anti-CCR8 antibody.
NCT03801876
A study for patients with Stage I-IVA adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction.
Key Inclusion Criteria:
- Histology: Adenocarcinoma or squamous cell carcinoma of esophagus or GEJ.
- Stage: I-IVA (AJCC 8th ed), excluding T4b disease.
Key Exclusion Criteria:
- Definitive evidence of metastatic disease.
- T4b disease.
NCT04065399
For patients with relapsed or refractory acute leukemias, including those with a KMT2A gene rearrangement or NPM1 mutation.
NCT04333537
A study for patients with early-stage (T1-2N0M0) squamous cell carcinoma of the oral cavity.
Key Inclusion Criteria:
- Clinical stage T1-2N0M0 (AJCC 8th ed.) squamous cell carcinoma of the oral cavity.
- Candidate for surgical intervention with SLN biopsy or elective neck dissection.
Key Exclusion Criteria:
- Clinical or radiologic evidence of regional or distant metastatic disease.
- Prior systemic chemotherapy for the study cancer.
NCT03800693
A study for patients with gastrointestinal cancers who are planned to receive FOLFOX6 chemotherapy.
Key Inclusion Criteria:
- Planned to receive at least 4 cycles of FOLFOX6-containing chemotherapy.
- Histologically confirmed, measurable or evaluable disease.
Key Exclusion Criteria:
- Pre-existing grade 2 or higher peripheral neuropathy.
- Anticancer therapy within 14 days of starting FOLFOX6.
NCT04260022
A study for patients with refractory Chronic Myeloid Leukemia (CML) or Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).
Key Inclusion Criteria:
- Diagnosis of CML (chronic, accelerated, or blast phase) or Ph+ ALL.
- Resistant or intolerant to at least two prior TKIs.
Key Exclusion Criteria:
- Prior treatment with HQP1351.
- CML chronic phase patients with a complete cytogenetic response (CCyR).
NCT05929768
A study for patients with early-stage (Stage I-IIIB) triple-negative breast cancer (TNBC).
Key Inclusion Criteria:
- Histologically confirmed triple-negative breast cancer (TNBC).
- Clinical stage T2-T4, N0, M0 or T1-T3, N1-2, M0.
Key Exclusion Criteria:
- Metastatic disease (M1).
- T4/N+, any N3, or inflammatory breast cancer.
NCT05281471
A study for women with platinum-resistant or refractory ovarian, fallopian tube, or primary peritoneal cancer.
Key Inclusion Criteria:
- Platinum-resistant or -refractory disease (PFI ≤ 6 months).
- Histology: High-grade serous, endometrioid, or clear-cell.
Key Exclusion Criteria:
- Histology: Mucinous, low-grade serous, squamous, small cell, or non-epithelial.
- Prior virus-based gene therapy or cytolytic virus therapy.
NCT03193970
A registry study for patients with bladder cancer who are undergoing a radical cystectomy.
Key Inclusion Criteria:
- Scheduled to undergo radical cystectomy for bladder cancer.
NCT05244239
A study of palliative radiotherapy with lurbinectedin for patients with extensive stage small cell lung cancer (SCLC).
Key Inclusion Criteria:
- Pathologically confirmed extensive-stage SCLC.
- Progression after one line of platinum-based chemotherapy or chemoimmunotherapy.
Key Exclusion Criteria:
- Brain metastases are not an eligible site for palliative RT on this study.
- Target lesion is within 2cm of previously irradiated critical structures.
NCT03816345
A study of nivolumab for patients with various advanced, metastatic, or unresectable cancers who also have a pre-existing autoimmune disorder.
Key Inclusion Criteria:
- Must have a pre-existing autoimmune disorder; multiple autoimmune diseases are allowed.
- Histologically confirmed metastatic/unresectable malignancy or eligible for adjuvant PD-1/L1 inhibitor.
Key Exclusion Criteria:
- Prior therapy with an anti-PD-1 or anti-PD-L1 agent.
- Chemotherapy or radiotherapy within 2 weeks of study entry (6 weeks for some agents).
NCT06486441
A study for patients with recurrent or persistent endometrial cancer who have previously received platinum-based chemotherapy and immunotherapy.
Key Inclusion Criteria:
- Histology of endometrial carcinoma or carcinosarcoma.
- Prior platinum-based chemotherapy and anti-PD-1/PD-L1 therapy required.
Key Exclusion Criteria:
- Uterine leiomyosarcoma or endometrial stromal sarcomas.
- Prior treatment with a Trop-2-directed ADC.
NCT05384626
A study for patients with advanced non-small cell lung cancer (NSCLC) or other solid tumors that have an ALK rearrangement or activating ALK mutation.
Key Inclusion Criteria:
- Advanced/metastatic NSCLC or solid tumor with ALK rearrangement or activating mutation.
- Measurable disease per RECIST 1.1 (Phase 2) or evaluable disease (Phase 1).
Key Exclusion Criteria:
- Known oncogenic driver alteration other than ALK.
- Major surgery within 4 weeks of study entry.
NCT04266275
A study of topical curcumin for women with low-grade (LSIL) or recently treated high-grade (HSIL) cervical intraepithelial neoplasia.
Key Inclusion Criteria:
- Biopsy-proven LSIL or recently treated HSIL disease
- HIV-uninfected or infected women eligible
Key Exclusion Criteria:
- Untreated HSIL or invasive features on colposcopy/biopsy
- Prior diagnosis of cervical cancer
NCT07174570
A phase 2 trial for patients with advanced or metastatic hepatocellular carcinoma (HCC).
Key Inclusion Criteria:
- Radiologically measurable disease per RECIST 1.1.
- Completion of prior cancer therapy ≥ 4 weeks before study start.
Key Exclusion Criteria:
- Child-Pugh score B7 or higher.
- Prior immune checkpoint inhibitor (ICI) therapy within 6 months.
NCT05377996
A study for patients with recurrent or advanced solid tumors, including triple-negative breast, endometrial, ovarian, and other specified cancers.
Key Inclusion Criteria:
- Measurable disease (target lesion) or non-target lesion per RECIST 1.1.
- Tumor tissue (archival or fresh biopsy) available for testing.
Key Exclusion Criteria:
- Untreated or progressive CNS metastases; history of leptomeningeal disease.
- Prior treatment with an ADC containing an auristatin payload.
NCT05570253
A study for patients with metastatic triple-negative breast cancer (TNBC) and metabolic dysfunction.
Key Inclusion Criteria:
- Metabolic dysfunction (HbA1c > 5.5 and/or BMI ≥ 30).
- Histologically confirmed triple-negative breast cancer (ER/PR ≤10%, HER2-negative).
Key Exclusion Criteria:
- Known brain metastases or active CNS pathology.
- Type 1 or uncontrolled/insulin-dependent Type 2 diabetes.
NCT06914999
A study for patients with Stage I-IVb squamous cell carcinoma of the oropharynx, larynx, or hypopharynx.
Key Inclusion Criteria:
- Diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx.
- Stage III-IVb for HPV-negative oropharynx, larynx, or hypopharynx.
Key Exclusion Criteria:
- Planned to receive immunotherapy during or after radiotherapy.
- Chemotherapy or radiotherapy within 4 weeks of study entry.
NCT06745908
A study for patients with advanced or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) who have developed resistance to prior immune checkpoint inhibitor therapy.
Key Inclusion Criteria:
- Acquired resistance to exactly one prior line of anti-PD-L1/CTLA-4 therapy.
- Must have an actionable genomic alteration (AGA) such as EGFR, ROS1, BRAF, MET, RET, or KRAS.
Key Exclusion Criteria:
- Patients with an ALK genomic alteration.
- Systemic autoimmune disease currently requiring treatment.
NCT06457503
A study of toripalimab with chemotherapy for patients with recurrent or metastatic nasopharyngeal cancer.
Key Inclusion Criteria:
- Histologically confirmed recurrent/metastatic NPC (EBV+ or EBV-).
- Stage IV-B disease or recurrent NPC after curative treatment.
Key Exclusion Criteria:
- Prior systemic therapy for recurrent or metastatic disease.
- Disease recurrence within 6 months of curative chemoradiation.
NCT04301076
A study of lenalidomide plus EPOCH chemotherapy for patients with Adult T-Cell Leukemia-Lymphoma (ATLL).
Key Inclusion Criteria:
- Confirmed CD2+, CD3+, or CD4+ acute, lymphoma or poor-risk chronic ATLL.
- Documented HTLV-1 infection.
Key Exclusion Criteria:
- Prior treatment with IMiDs for ATLL.
- Chemotherapy or radiotherapy within 4 weeks prior to study entry.
NCT07116616
A study for patients with relapsed or refractory multiple myeloma.
Key Inclusion Criteria:
- Prior exposure to a proteasome inhibitor, IMiD, and anti-CD38 mAb.
- Measurable disease (e.g., M-protein ≥0.5 g/dL, involved FLC ≥100 mg/L, or plasmacytoma ≥2 cm).
Key Exclusion Criteria:
- Known central nervous system (CNS) myeloma.
- Active plasma cell leukemia (peripheral blood plasma cells ≥20%).
NCT06926920
A study of sacituzumab govitecan for patients with advanced triple-negative breast cancer (TNBC).
Key Inclusion Criteria:
- Histologically confirmed unresectable, locally advanced or metastatic TNBC.
- Phase 2: PD-L1 negative (CPS < 10), or CPS ≥ 10 if prior/ineligible for anti-PD-(L)1.
Key Exclusion Criteria:
- Prior treatment with a Trop-2-directed ADC.
- Prior treatment with a topoisomerase 1 inhibitor or an ADC containing one.
NCT04567420
A study for patients with high-risk, ER-positive, HER2-negative breast cancer who have completed or are on adjuvant endocrine therapy.
Key Inclusion Criteria:
- High-risk, ER-positive (>=10%), HER2-negative invasive breast cancer.
- ctDNA positive by Signatera assay (for randomization).
Key Exclusion Criteria:
- Prior or current treatment with fulvestrant.
- Current CDK4/6 inhibitor use or use within prior 12 months.
NCT03151629
A registry for men with advanced prostate cancer, including metastatic hormone-sensitive (mHSPC) and castration-resistant (CRPC) disease.
Key Inclusion Criteria:
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Alternatively, metastatic disease typical of prostate cancer with PSA >20 ng/mL at initial diagnosis.
Key Exclusion Criteria:
- Any other malignancy requiring systemic therapy (exceptions: bladder cancer in situ, basal cell skin cancer).
NCT05783622
A study for patients with advanced or metastatic solid tumors, including NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, and TNBC.
Key Inclusion Criteria:
- Locally advanced or metastatic solid tumor (NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, TNBC).
- Progressed on or intolerant to all available standard therapies.
Key Exclusion Criteria:
- Prior EGFR-targeted bispecific T cell engager or CAR-T cell therapy.
- Prior CD3 engaging bispecific antibodies.
NCT04930653
A trial for patients with erythrodermic Cutaneous T-Cell Lymphoma (CTCL), including Mycosis Fungoides and Sezary Syndrome.
Key Inclusion Criteria:
- Histologically confirmed Mycosis Fungoides (MF) or Sezary Syndrome (SS).
- Stage ≥IB required; specific criteria for safety lead-in cohort.
Key Exclusion Criteria:
- Prior treatment with mogamulizumab.
- Prior stem cell transplantation.
NCT05846789
A study for patients with metastatic triple-negative or estrogen-receptor (ER)-low breast cancer.
Key Inclusion Criteria:
- Locally recurrent or metastatic TNBC or ER-low (ER/PR ≤9%) breast cancer.
- Up to 2 prior lines of therapy for metastatic disease.
Key Exclusion Criteria:
- HER2-positive disease.
- Prior treatment with tocilizumab or other IL-6/IL-6R targeted agents.
NCT05787587
A study for patients with various advanced or metastatic solid tumors, including breast, ovarian, prostate, and endometrial cancer, with specific genetic alterations.
Key Inclusion Criteria:
- Module 1: Documented BRCA1/2 or other specified HRD gene alteration.
- Module 2: Advanced/metastatic endometrial cancer (carcinosarcoma excluded).
Key Exclusion Criteria:
- Known primary CNS malignancy.
- Module 2: Active autoimmune disease requiring systemic treatment in past 2 years.
NCT05137054
A study for adult patients with relapsed or refractory multiple myeloma (RRMM).
Key Inclusion Criteria:
- Relapsed/refractory multiple myeloma (RRMM) with measurable disease.
- Progression after at least 2-3 prior lines of therapy (cohort-dependent).
Key Exclusion Criteria:
- Prior BCMA-directed T-cell immunotherapy (bispecifics, BiTEs, CAR-T).
- Diagnosis of plasma cell leukemia, primary amyloidosis, Waldenström's, or POEMS syndrome.
NCT04251052
A study for individuals with BRCA1 mutations to compare two surgical procedures for reducing the risk of ovarian cancer.
Key Inclusion Criteria:
- Documented pathogenic or likely pathogenic germline BRCA1 mutation.
- Pelvic ultrasound/MRI and CA-125 within 180 days of registration.
Key Exclusion Criteria:
- Prior history of ovarian, primary peritoneal, or fallopian tube carcinoma.
- History of any cancer treated with cytotoxic chemotherapy within 30 days.
NCT05735184
A study for patients with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) with an NPM1 mutation or KMT2A rearrangement.
Key Inclusion Criteria:
- AML with documented NPM1 mutation or KMT2A rearrangement.
- Arm C only: NPM1-mutated and FLT3-ITD positive (allelic ratio ≥0.05).
Key Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia or CML in blast phase.
- Known BCR-ABL alteration.
NCT06567743
A study for patients with high-risk non-muscle-invasive bladder cancer (NMIBC).
Key Inclusion Criteria:
- High-risk high-grade NMIBC (CIS +/- Ta/T1 or HG Ta/T1 papillary-only).
- Separate cohorts for BCG-naïve, BCG-exposed, or BCG-unresponsive patients.
Key Exclusion Criteria:
- History of muscle-invasive, locally advanced, or metastatic bladder cancer.
- High-grade urothelial carcinoma in upper urinary tract or prostatic urethra within 24 months.
NCT05835466
A study for patients with primary myelofibrosis (PMF) or myelofibrosis that has developed after essential thrombocythemia (ET) or polycythemia vera (PV).
Key Inclusion Criteria:
- Diagnosis of PMF, post-ET-MF, or post-PV-MF with DIPSS intermediate-2 or high-risk disease.
- Refractory, resistant, intolerant, or ineligible for JAK inhibitor (JAKi) therapy.
Key Exclusion Criteria:
- Other invasive malignancies within the last 3 years.
- Hematopoietic cell transplant (HCT) within 100 days or ongoing immunosuppression post-HCT.
NCT03997370
A study for patients with any malignant solid neoplasm who are scheduled to receive treatment with intravenous carboplatin.
Key Inclusion Criteria:
- Scheduled to receive intravenous carboplatin as part of an NCI-sponsored trial or standard of care.
Key Exclusion Criteria:
- History of allergic reaction to CT contrast, iodine, or shellfish.
- Acute kidney injury within 6 months, sickle cell disease, or indwelling nephrostomy tubes.
NCT03418961
A study for patients with metastatic or recurrent HER2-positive breast cancer who are at risk of cardiac toxicity from treatment.
Key Inclusion Criteria:
- Initiating or continuing trastuzumab-based therapy for metastatic disease (1st-4th line).
- Increased risk for cardiotoxicity (e.g., prior anthracycline, age ≥65, BMI ≥30).
Key Exclusion Criteria:
- Concurrent treatment with anthracyclines.
- Receiving lapatinib without trastuzumab.
NCT06580314
A study of maintenance olaparib for patients with newly diagnosed, advanced (Stage III-IV) ovarian, fallopian tube, or primary peritoneal cancer with a BRCA1/2 mutation or HRD+ status, following a response to first-line platinum chemotherapy.
Key Inclusion Criteria:
- Newly diagnosed, FIGO Stage III or IV ovarian, fallopian, or peritoneal cancer.
- High-grade serous/endometrioid histology, or other epithelial with BRCA1/2 mutation.
Key Exclusion Criteria:
- Prior treatment with any PARP inhibitor.
- Disease progression after first-line platinum-based chemotherapy.
NCT07112690
A supportive care study for patients with localized anal or perianal skin cancer undergoing chemoradiation.
Key Inclusion Criteria:
- Pain score ≥5 or high pain interference/distress.
- Life expectancy >12 months.
Key Exclusion Criteria:
- ANC <1500.
- Platelet count <80,000.
NCT07203911
A study for patients with T1-T3 oral squamous cell carcinoma undergoing surgical treatment.
Key Inclusion Criteria:
- Biopsy-proven T1-T3 oral squamous cell carcinoma.
- Scheduled for surgical treatment.
Key Exclusion Criteria:
- Suspected bone involvement.
- Prior radiotherapy to the oral cavity.
NCT05296070
A study for patients with relapsed or refractory Marginal Zone Lymphoma (MZL), including extranodal, nodal, and splenic subtypes.
Key Inclusion Criteria:
- Relapsed/refractory after >=1 prior line of systemic therapy.
- Must have received at least one prior anti-CD20 antibody therapy.
Key Exclusion Criteria:
- Evidence of transformation to Diffuse Large B-cell Lymphoma (DLBCL).
- Prior treatment with any anti-CD19 therapy.
NCT06638307
A study for adult participants with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
Key Inclusion Criteria:
- Tumor must have genetic alterations in PIK3CA, AKT1, or PTEN.
- Progression on a prior CDK4/6 inhibitor with fulvestrant or an aromatase inhibitor.
Key Exclusion Criteria:
- Active or newly diagnosed central nervous system (CNS) metastases.
- Advanced, symptomatic visceral spread with risk of life-threatening complications.
NCT05310448
A study for patients with gliomas located in the brainstem.
Key Inclusion Criteria:
- Diagnosis of glioma with involvement of thalamus, cerebral peduncles, midbrain, pons, or medulla.
- Completed all prior cancer therapy (surgery, RT) ≥4 weeks before study start.
Key Exclusion Criteria:
- Completed chemotherapy or radiotherapy >26 weeks prior to study entry.
- Receiving other investigational agents/devices within 21 days of study start.
NCT07140679
For patients with resected, localized, high-risk Stage IIB, IIC, or III colon cancer that is mismatch repair deficient (dMMR).
Key Inclusion Criteria:
- Pathologic stage IIB, IIC, or III colon cancer.
- Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).
Key Exclusion Criteria:
- Presence of metastatic disease.
- Prior neoadjuvant therapy for colon cancer.
NCT05548296
A study for patients with high-grade, metastatic endometrial adenocarcinoma that has progressed after prior therapy.
Key Inclusion Criteria:
- Histologically confirmed, high-grade, metastatic endometrial cancer.
- Prior platinum-based chemotherapy and anti-PD-(L)1 therapy required.
Key Exclusion Criteria:
- Mesenchymal tumors of the uterus.
- Prior treatment with a CHK1 inhibitor.
NCT05735080
A study for patients with advanced or metastatic cancers, including HR+/HER2- breast cancer, platinum-resistant/refractory ovarian cancer, or other solid tumors with CCNE1 amplification.
Key Inclusion Criteria:
- Advanced/metastatic ER+/HER2- BC, progressed on a CDK4/6 inhibitor.
- Advanced/metastatic platinum-resistant/refractory ovarian cancer with CCNE1 amplification.
Key Exclusion Criteria:
- Prior therapy with a CDK2/4/6 or CDK2 inhibitor.
- Symptomatic CNS metastases or spinal cord compression requiring corticosteroids.
NCT06760637
A study for adults with HR-positive, HER2-negative advanced or metastatic breast cancer who have not received prior systemic therapy for advanced disease.
Key Inclusion Criteria:
- Locally advanced or metastatic disease not amenable to curative therapy.
- Documented ER and/or PR-positive tumor.
Key Exclusion Criteria:
- In visceral crisis or at risk of life-threatening complications.
- Current or past history of central nervous system (CNS) metastases.
NCT06328686
A study for patients with brain metastases from any primary cancer who are planned to undergo whole brain radiation therapy.
Key Inclusion Criteria:
- Diagnosis of brain metastases from any primary cancer.
- Planned to undergo whole-brain radiation therapy (WBRT).
Key Exclusion Criteria:
- Systemic therapy continuing during WBRT.
- Pregnant.
NCT06026332
A study for patients with bladder cancer who are being treated with Adstiladrin in a real-world setting.
Key Inclusion Criteria:
- Prescribed and scheduled for treatment with Adstiladrin.
Key Exclusion Criteria:
- Previously treated with Adstiladrin in a clinical trial.
- Currently enrolled in another clinical trial.
NCT05839912
A study for patients with Stage III melanoma who have a single, clinically positive lymph node.
Key Inclusion Criteria:
- Metastatic melanoma confirmed in a single, clinically positive lymph node.
- No other radiologically evident metastases on PET-CT and head CT/MRI.
Key Exclusion Criteria:
- Metastases distant to the involved lymph node basin.
- Current or recent (<1 year) in-transit or satellite metastases.
NCT03260491
A study for patients with metastatic or unresectable Non-Small Cell Lung Cancer (NSCLC).
Key Inclusion Criteria:
- Locally advanced or metastatic NSCLC, not amenable to curative therapy.
- Specific cohorts for EGFR-mutant, KRAS-G12C mutant, or EGFR wild-type NSCLC.
Key Exclusion Criteria:
- Any evidence of small cell or combined small cell/non-small cell histology.
- Prior anti-HER3 antibody or certain topoisomerase I inhibitor-based ADCs.
NCT04776395
A study of iberdomide for patients with intermediate- or high-risk smoldering multiple myeloma.
Key Inclusion Criteria:
- Diagnosis of intermediate- or high-risk smoldering multiple myeloma (SMM).
- At least one: BM plasma cells ≥20%, sFLC ratio >20, or M-protein ≥2 g/dL.
Key Exclusion Criteria:
- Active multiple myeloma requiring treatment (SLiM-CRAB criteria).
- Prior or ongoing treatment for any plasma cell disorder.
NCT03678025
A study for patients with metastatic prostate cancer to evaluate standard systemic therapy with or without definitive treatment of the primary tumor.
Key Inclusion Criteria:
- Intact prostate gland.
- Metastatic disease confirmed by conventional imaging (CT/MRI, bone scan).
Key Exclusion Criteria:
- Histology other than adenocarcinoma (e.g., small cell, sarcomatoid).
- Prior local therapy for prostate cancer (e.g., brachytherapy, HIFU, cryotherapy).
NCT06709534
A study for survivors of gynecologic cancers, such as uterine, ovarian, or cervical cancer, who have completed treatment.
Key Inclusion Criteria:
- Completed prior cancer treatment (chemotherapy or chemoradiation).
- Does not meet recommended exercise levels (ACSM).
Key Exclusion Criteria:
- History of metastatic or other primary cancer.
- Serious mental health conditions (e.g., bipolar disorder, schizophrenia, major depression).
NCT05998135
A Phase 2 trial of atovaquone for patients with platinum-resistant, high-grade serous ovarian cancer.
Key Inclusion Criteria:
- High-grade serous ovarian cancer.
- Platinum-resistant disease, defined as progression within 6 months of last platinum chemo.
Key Exclusion Criteria:
- Pregnant or breastfeeding.
NCT05555732
A study for patients with previously untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with PD-L1 TPS <50% and no actionable genomic alterations.
Key Inclusion Criteria:
- Advanced or metastatic non-squamous NSCLC without actionable genomic alterations.
- PD-L1 TPS <50% confirmed by central lab.
Key Exclusion Criteria:
- Prior treatment with topoisomerase I inhibitors, TROP2-targeted therapy, or any immunotherapy.
- Active, untreated CNS metastases or spinal cord compression.
NCT01255748
A registry study for patients with any type of cancer (neoplasm) who are undergoing treatment with radiation therapy.
NCT03721068
A study of CAR T-cell therapy for patients with relapsed or refractory neuroblastoma or osteosarcoma.
Key Inclusion Criteria:
- Histologically confirmed neuroblastoma, ganglioneuroblastoma, or osteosarcoma.
- High-risk neuroblastoma that is relapsed, progressive, or refractory.
Key Exclusion Criteria:
- Known Central Nervous System (CNS) disease.
- Seizure disorder requiring antiepileptic drug therapy.
NCT05919108
A trial for patients with Stage I-III, HER2-mutated, invasive lobular breast cancer.
Key Inclusion Criteria:
- Stage I-III, HR+ (ER≥1%), invasive lobular carcinoma (ILC).
- Documented activating HER2 mutation from a CLIA-certified lab.
Key Exclusion Criteria:
- Evidence of distant metastatic disease.
- HER2 amplification by FISH or IHC (3+).
NCT07003100
An observational study for patients with relapsed/refractory Mycosis Fungoides or Sezary Syndrome who are starting treatment with mogamulizumab.
Key Inclusion Criteria:
- Relapsed/refractory Mycosis Fungoides (Stage IB-IV) or Sezary Syndrome.
- Selected by treating physician to receive newly initiated single-agent mogamulizumab.
Key Exclusion Criteria:
- Prior treatment with mogamulizumab.
- Concomitant systemic and skin-directed CTCL regimens, except for topical steroids.
NCT05856773
A study for patients with Stage I-III breast cancer who require postoperative radiation therapy to the breast or chest wall and regional lymph nodes.
Key Inclusion Criteria:
- Stage I-III breast cancer requiring postoperative comprehensive nodal irradiation.
- Must have undergone breast conserving surgery or mastectomy.
Key Exclusion Criteria:
- Inflammatory breast cancer or T4b/T4c disease.
- Evidence of distant metastatic disease.
NCT03970447
A study for patients with newly diagnosed or recurrent glioblastoma.
Key Inclusion Criteria:
- Histologically confirmed Grade IV GBM or gliosarcoma (IDH wild-type).
- Patient must be either newly diagnosed OR at 1st/2nd recurrence.
Key Exclusion Criteria:
- For newly diagnosed: Any prior treatment for glioma (RT, chemo, immunotherapy).
- For recurrent: Prior lomustine, bevacizumab, or other VEGF/VEGFR targeted agents.
NCT05095376
For patients with newly diagnosed, MGMT-methylated glioblastoma or gliosarcoma.
Key Inclusion Criteria:
- MGMT promoter methylation confirmed centrally.
- IDH wildtype status confirmed.
Key Exclusion Criteria:
- Prior therapy for GBM/glioma (chemo, RT, immunotherapy) except resection/LITT.
- Metastatic disease outside the brain.
NCT03322891
A study for newly diagnosed, early-stage African American men with prostate cancer.
Key Inclusion Criteria:
- AJCC clinical stage T1-T2 prostate cancer.
- Self-identifies as African-American.
Key Exclusion Criteria:
- History of cognitive impairment, head injury, or dementia.
- Holds an RN or MD degree.
NCT07150546
A study for patients with large, unresectable, well-differentiated grade 1-2 gastrointestinal neuroendocrine tumors.
Key Inclusion Criteria:
- Unresectable, well-differentiated, grade 1-2 neuroendocrine tumor.
- Somatostatin-receptor positive disease (modified Krenning score 3+).
Key Exclusion Criteria:
- Brain metastases or metastases extending into the spinal canal.
- Any prior radiation, PRRT, or Y-90 radioembolization to the same region.
NCT05208307
A study of belantamab mafodotin, pomalidomide, and dexamethasone as maintenance therapy for patients with high-risk plasma cell myeloma.
Key Inclusion Criteria:
- Post-ASCT (within 1 year of diagnosis) with ≥ Partial Response.
- High-risk cytogenetics (del(17p), t(4;14), t(14;16), t(14;20)) or plasma cell leukemia.
Key Exclusion Criteria:
- Not high-risk myeloma (e.g., smoldering, MGUS, standard-risk).
- Current corneal epithelial disease (mild changes acceptable).
NCT04554914
A study for patients with various Epstein-Barr Virus (EBV)-associated diseases, including lymphoproliferative disorders and sarcomas.
Key Inclusion Criteria:
- Confirmed diagnosis of specific EBV+ disorder (LPD, PTLD, or sarcoma).
- Relapsed/refractory (R/R) disease OR newly diagnosed and inappropriate for standard 1L therapy.
Key Exclusion Criteria:
- Active Burkitt, T-cell/NK lymphoma, Hodgkin, or other malignancy requiring systemic therapy.
- PID/AID LPD cohorts: History of prior allogeneic HCT or solid organ transplant.
NCT06492070
A study for patients with gynecological cancers, including uterine, ovarian, fallopian tube, primary peritoneal, cervical, or vulvar cancer.
Key Inclusion Criteria:
- Planned chemotherapy regimen of 6-9 cycles of paclitaxel and carboplatin or cisplatin.
- Arm C: Must have completed 6-9 cycles of paclitaxel-based chemo within last 3 months.
Key Exclusion Criteria:
- Prior treatment with paclitaxel.
- Baseline neuropathy requiring pharmacologic treatment.
NCT06614192
A study for adult patients with refractory metastatic colorectal cancer (mCRC) whose tumors express c-Met protein above a specific cutoff level.
Key Inclusion Criteria:
- c-Met protein expression above a defined cutoff
- Measurable disease per RECIST v1.1
Key Exclusion Criteria:
- Prior therapy with a c-MET targeting antibody, bispecific, or ADC
- Known hypersensitivity to bevacizumab or trifluridine/tipiracil
NCT02693535
A study for patients with advanced solid tumors, multiple myeloma, or B-cell non-Hodgkin lymphoma who are no longer benefiting from standard therapy.
Key Inclusion Criteria:
- Tumor must have a genomic variant matching a study drug cohort.
- Locally advanced or metastatic solid tumor, multiple myeloma, or B-cell NHL.
Key Exclusion Criteria:
- Primary brain tumors or leptomeningeal metastases.
- Previously treated brain metastases must be stable for >=1 month off steroids.
NCT03850574
A study for patients with relapsed/refractory Acute Myeloid Leukemia (AML), MDS-IB2, or CMML, and for newly diagnosed AML patients ineligible for intensive chemotherapy.
Key Inclusion Criteria:
- R/R AML, MDS-IB2, or CMML OR newly diagnosed AML.
- Newly diagnosed AML cohort must be ineligible for intensive chemotherapy.
Key Exclusion Criteria:
- Acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia.
- Meningeal or central nervous system (CNS) involvement with leukemia.
NCT03053193
A registry study for patients with Stage I, II, or III breast cancer undergoing MammaPrint and BluePrint testing.
Key Inclusion Criteria:
- Stage I, II, or III disease.
- Must receive MammaPrint, with or without BluePrint testing.
Key Exclusion Criteria:
- Metastatic disease.
- Recurrent disease.
NCT06433947
A study for patients with relapsed or refractory multiple myeloma.
Key Inclusion Criteria:
- Relapsed/refractory to ≥3 prior lines of therapy.
- Prior therapy must include an IMiD, proteasome inhibitor, and anti-CD38 antibody.
Key Exclusion Criteria:
- Excludes MGUS, smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma.
- Active plasma cell leukemia.
NCT06868433
A study of a personalized vaccine, with or without pembrolizumab, for patients with recurrent or metastatic head and neck squamous cell cancer.
NCT05586360
A study for men with localized intermediate or high-risk prostate cancer scheduled for prostatectomy.
Key Inclusion Criteria:
- Localized intermediate-risk (Gleason 7, PSA 10-20, or T2b) or high-risk (Gleason ≥8, PSA ≥20, or T2c) disease.
- Scheduled to undergo prostatectomy.
Key Exclusion Criteria:
- Evidence or suspicion of metastases.
- Prior neoadjuvant/adjuvant chemotherapy, hormone therapy, or radiation therapy.
NCT01696721
A registry for pediatric patients with any type of cancer who are being treated with radiation therapy.
NCT04315324
A study for patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL).
Key Inclusion Criteria:
- Diagnosis of relapsed/refractory T-ALL or T-LBL.
- ≥5% lymphoblasts in bone marrow or peripheral blood.
Key Exclusion Criteria:
- CNS3 disease.
- Only extramedullary disease.
NCT04428671
A study of cemiplimab for patients with high-risk, metastatic, or recurrent cutaneous squamous cell carcinoma (cSCC) who are candidates for surgery.
Key Inclusion Criteria:
- Surgically resectable high-risk cutaneous squamous cell carcinoma (cSCC).
- Must have ≥1 high-risk feature: Nodal disease with ECE, in-transit metastases, T4 H&N lesion, or PNI.
Key Exclusion Criteria:
- Not a candidate for surgical resection.
- Active autoimmune disease or history of severe immune-mediated adverse events.
NCT06460298
A study of ProAgio with gemcitabine for patients with metastatic triple negative breast cancer.
Key Inclusion Criteria:
- Histologically confirmed metastatic TNBC (ER<10%, PR<10%, HER2-negative).
- At least two prior lines of systemic therapy for advanced disease.
Key Exclusion Criteria:
- Prior treatment with gemcitabine in the metastatic setting.
- History of significant cardiac disease (NYHA class >2B or LVEF <50%).
NCT06939283
A study for adult patients with selected advanced or metastatic solid tumors or Non-Hodgkin Lymphoma.
Key Inclusion Criteria:
- R/R locally advanced or metastatic solid tumor or advanced NHL.
- Specific cohorts: Melanoma post-CPI, MSS CRC (IO-naïve), or r/r FL/DLBCL.
Key Exclusion Criteria:
- Prior treatment with IL-12 by any route.
- Primary CNS malignancies or castrate-resistant prostate cancer (CRPC).
NCT05653271
A study of ACE1831 for adult patients with relapsed or refractory CD20-expressing B-cell malignancies.
Key Inclusion Criteria:
- CD20-positive, persistent or progressive B-cell NHL.
- At least 2 prior systemic therapies.
Key Exclusion Criteria:
- Prior genetically modified cell therapy targeting CD20.
- History of CNS lymphoma or primary CNS lymphoma.
NCT03990896
A study of Talazoparib for patients with metastatic breast cancer harboring a somatic BRCA1 or BRCA2 mutation.
Key Inclusion Criteria:
- Metastatic breast cancer with a deleterious somatic BRCA1 or BRCA2 mutation.
- TNBC subtype must have progressed on ≥1 prior chemotherapy for metastatic disease.
Key Exclusion Criteria:
- Known germline BRCA1 or BRCA2 mutation.
- Prior treatment with a PARP inhibitor.
NCT06276491
A study for patients with advanced, recurrent, or metastatic CLDN6-positive ovarian, endometrial, or germ cell tumors.
Key Inclusion Criteria:
- CLDN6+ tumor.
- Documented progressive disease on or intolerant to standard-of-care therapies.
Key Exclusion Criteria:
- Prior exposure to a CLDN6 targeting product.
- Known active CNS metastases (stable, treated metastases are allowed).
NCT01042379
A study of neoadjuvant and personalized novel agents for patients with locally advanced breast cancer.
Key Inclusion Criteria:
- Stage II, III, or regional Stage IV (supraclavicular nodes only) breast cancer.
- Tumor size ≥ 2.5 cm.
Key Exclusion Criteria:
- Evidence of distant metastases.
- Use of investigational agents within 30 days of starting treatment.
NCT05705401
A study for patients with low-risk, early-stage HER2-positive breast cancer who have undergone breast conserving surgery.
Key Inclusion Criteria:
- HER2-positive invasive breast carcinoma.
- Must have undergone breast conserving surgery (lumpectomy).
Key Exclusion Criteria:
- Definitive evidence of metastatic disease.
- Pathologically positive axillary nodes at any time.
NCT06595160
An observational study for patients with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC).
NCT05635643
A study for patients with advanced solid tumors, including specific cohorts for head and neck squamous cell carcinoma (HNSCC).
Key Inclusion Criteria:
- Locally advanced or metastatic solid tumor; specific cohorts for HNSCC.
- Progressed on/after standard therapy; HNSCC cohorts require prior platinum and/or PD-1/L1 inhibitor.
Key Exclusion Criteria:
- Prior anti-CCR8 antibody or targeted therapy.
- Primary tumor site of nasopharynx.
NCT05433142
A study for patients with advanced, relapsed, or refractory clear cell renal cell carcinoma (ccRCC).
Key Inclusion Criteria:
- Relapsed/refractory ccRCC with progression on standard-of-care therapies.
- Measurable disease per RECIST 1.1.
Key Exclusion Criteria:
- Active CNS metastases or carcinomatous meningitis.
- Prior treatment with an investigational anti-ENPP3/CD203c therapy.
NCT06423326
A study of neoadjuvant gemcitabine, cisplatin, and nab-paclitaxel for patients with resectable or borderline resectable pancreatic ductal adenocarcinoma.
Key Inclusion Criteria:
- Histologically confirmed resectable or borderline resectable PDAC.
- Resectability status confirmed by multidisciplinary review per NCCN guidelines.
Key Exclusion Criteria:
- Grade ≥2 peripheral neuropathy.
- Severe or uncontrolled medical conditions (cardiac, diabetes, infection).
NCT05756569
For patients with locally advanced or metastatic bladder cancer of variant histology.
Key Inclusion Criteria:
- Metastatic or unresectable locally advanced disease.
- Histologically confirmed variant or non-urothelial bladder cancer.
Key Exclusion Criteria:
- Neuroendocrine or non-epithelial bladder tumor histology.
- Prior treatment with enfortumab vedotin (EV) or PD-1/PD-L1 inhibitors.
NCT05237258
A study for patients with high-risk, relapsed, or primary refractory Acute Myeloid Leukemia (AML).
Key Inclusion Criteria:
- High-risk AML: newly diagnosed ≥60, antecedent hematologic disorder, therapy-related, or relapsed/refractory.
- Within 5 business days of initiating intensive chemotherapy or hypomethylating agents.
Key Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia (APML).
- Receiving supportive care alone.
NCT00756665
A study for men with clinically localized prostate cancer who have chosen active surveillance as their management plan.
Key Inclusion Criteria:
- Clinically localized prostate cancer (T1-2, N0/NX, M0/MX).
- Patient has elected Active Surveillance as management plan.
Key Exclusion Criteria:
- Unwilling or unable to undergo serial prostate biopsy.
- History of other malignancies, except specific curatively treated cancers.
NCT03690986
A study for patients with surgically resectable, Stage I-IVA Squamous Cell Carcinoma of the Head and Neck (HNSCC).
Key Inclusion Criteria:
- Stage I-IVA surgically resectable HNSCC.
- Oropharyngeal tumors must have p16 testing performed.
Key Exclusion Criteria:
- Nasopharynx, unknown primary, or sinonasal cancer.
- Not a surgical candidate due to medical co-morbidities.
NCT05549297
A study of tebentafusp for patients with previously treated, advanced non-ocular melanoma.
Key Inclusion Criteria:
- HLA-A*02:01 positive.
- Unresectable Stage III or Stage IV non-ocular melanoma.
Key Exclusion Criteria:
- Diagnosis of ocular or metastatic uveal melanoma.
- Untreated or symptomatic CNS metastases.
NCT04049669
A trial for pediatric and young adult patients with relapsed brain tumors (glioblastoma, medulloblastoma, ependymoma) or newly diagnosed diffuse intrinsic pontine glioma (DIPG).
Key Inclusion Criteria:
- Progressive glioblastoma, medulloblastoma, or ependymoma OR newly diagnosed DIPG.
- Relapsed patients must have received prior therapeutic radiation.
Key Exclusion Criteria:
- Any prior radiation or medical therapy for newly diagnosed DIPG.
- Prior treatment with indoximod.
NCT06171685
A study for patients with relapsed or refractory multiple myeloma.
Key Inclusion Criteria:
- Relapsed/refractory to a PI, an IMiD, and an anti-CD38 mAb.
- Received 1-4 prior lines of systemic therapy.
Key Exclusion Criteria:
- Plasma cell leukemia, Waldenström's, POEMS, or primary amyloidosis.
- Complete cord compression or CNS involvement.
NCT05651932
A study for patients with relapsed or refractory multiple myeloma.
Key Inclusion Criteria:
- t(4;14) confirmed by FISH testing.
- ≥ 3 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 antibody.
Key Exclusion Criteria:
- Current plasma cell leukemia, POEMS syndrome, solitary bone lesion, MDS, or amyloidosis.
- Extramedullary disease (applies to Cohorts A, C, and D only).
NCT04732065
A study of ONC206 for newly diagnosed or recurrent diffuse midline gliomas (DMG) and other recurrent malignant central nervous system (CNS) tumors.
Key Inclusion Criteria:
- Diagnosis of H3K27-altered DMG or other recurrent primary malignant CNS tumor.
- Specific disease status: newly diagnosed (Arm B) or recurrent/progressive (Arms A, C, D).
Key Exclusion Criteria:
- Currently receiving other anti-cancer agents or investigational drugs.
- Prior treatment with ONC201 in the upfront setting (for Arms C & D).
NCT05514717
For patients with advanced or recurrent solid tumors that express HER2.
Key Inclusion Criteria:
- Recurrent or metastatic solid tumors with HER2 expression (IHC 3+ or IHC 2+/ISH+).
- Disease progression after, intolerance to, or contraindication for available standard therapies.
Key Exclusion Criteria:
- Untreated CNS metastases, leptomeningeal metastasis, or carcinomatous meningitis.
- ERBB2-activating mutations or gene amplification without HER2 positivity.
NCT03858205
A study of low-dose radiotherapy for painful bone metastases in patients with multiple myeloma.
Key Inclusion Criteria:
- Painful bone metastasis (index lesion) with a radiographic correlate.
- Brief Pain Inventory (BPI) score of 2 or greater.
Key Exclusion Criteria:
- Prior radiation therapy or palliative surgery to the index lesion.
- Clinical or radiographic evidence of spinal cord or cauda equina compression.
NCT06097832
A study for patients with relapsed or refractory light chain (AL) amyloidosis.
Key Inclusion Criteria:
- Histologically proven systemic AL amyloidosis.
- Measurable hematologic disease (dFLC >20 mg/L or M-spike >0.5mg/dl).
Key Exclusion Criteria:
- Prior CAR T therapy or any BCMA-targeted therapy.
- Bone marrow plasma cells >30% or symptomatic multiple myeloma.
NCT05086692
A study for patients with locally advanced or metastatic solid tumors.
Key Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor.
- Measurable disease per RECIST v1.1.
Key Exclusion Criteria:
- Active CNS metastases or carcinomatous meningitis.
- Active or suspected autoimmune disease.
NCT03435796
A long-term follow-up study for patients with various neoplasms who have previously received gene-modified T-cell therapy.
Key Inclusion Criteria:
- Received at least one gene-modified (GM) T-cell infusion in a prior parent trial.
- Completed or discontinued the post-treatment follow-up period in the parent protocol.
NCT06865768
A diagnostic imaging study for men with suspected prostate cancer who are scheduled for a prostate biopsy.
Key Inclusion Criteria:
- Suspected prostate cancer and scheduled for prostate biopsy for confirmation.
- Ability to lie still for MRI scanning.
Key Exclusion Criteria:
- Contraindications for MRI (e.g., pacemakers, cochlear implants).
- Uni- or bilateral hip prosthesis.
NCT06731270
A study of diclofenac for patients with advanced or metastatic non-small cell lung cancer (NSCLC) showing early signs of progression on single-agent immunotherapy.
Key Inclusion Criteria:
- Advanced (Stage III) or metastatic (Stage IV) NSCLC.
- Currently receiving single-agent PD(L)-1 inhibitor for ≥12 weeks.
Key Exclusion Criteria:
- Any contraindication to NSAID therapy (e.g., ulcerative disease, bleeding risk, allergy).
- Receiving prophylactic or therapeutic anticoagulation.
NCT06324240
A study for patients with early stage (I-III), locally advanced, or metastatic triple-negative breast cancer (TNBC).
Key Inclusion Criteria:
- Histologically confirmed TNBC (ER/PR ≤10%, HER2-negative).
- Stage I-III OR metastatic/inoperable locally advanced disease.
Key Exclusion Criteria:
- Active CNS metastases or carcinomatous meningitis.
- Active autoimmune disease requiring systemic treatment in the last 2 years.
NCT02074839
A study for patients with advanced IDH1-mutated hematologic malignancies, including relapsed/refractory or untreated AML and myelodysplastic syndromes.
Key Inclusion Criteria:
- Documented IDH1 R132 gene-mutated advanced hematologic malignancy.
- Amenable to serial bone marrow biopsies and blood/urine sampling.
Key Exclusion Criteria:
- Known or suspected active CNS leukemia.
- HSCT within 60 days of first dose.
NCT05079282
A study for patients with specific subtypes of relapsed or refractory Peripheral T-cell lymphoma (PTCL) or Cutaneous T-cell lymphoma (CTCL).
Key Inclusion Criteria:
- Histologically confirmed PTCL (AITL, PTCL-NOS, nodal PTCL with TFH, FTCL).
- Histologically confirmed CTCL (MF or SS) stages II-B, III, or IV.
Key Exclusion Criteria:
- Adult T-cell leukemia/lymphoma (ATLL).
- Central nervous system (CNS) involvement.
NCT06119685
A study for patients with advanced, relapsed or refractory hematologic cancers, including Multiple Myeloma (MM) and Non-Hodgkin's Lymphoma (NHL).
Key Inclusion Criteria:
- Diagnosis of relapsed/refractory (R/R) Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL).
- For MM: ≥ 3 prior lines of therapy.
Key Exclusion Criteria:
- Untreated central nervous system, epidural, or brain metastasis.
- Impaired cardiac function or clinically significant cardiac disease.
NCT04483206
A study for patients with multiple myeloma undergoing an autologous stem cell transplant.
Key Inclusion Criteria:
- Phase A: Must have received 2+ lines of therapy.
- Phase B: Transplant must be part of first-line therapy.
Key Exclusion Criteria:
- Progressive disease or clinical relapse between screening and day -3.
- Excludes POEMS syndrome, AL amyloidosis, and Waldenstrom macroglobulinemia.
NCT04996875
A study for patients with Advanced Systemic Mastocytosis (AdvSM), including Aggressive SM (ASM), SM with an Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).
Key Inclusion Criteria:
- Diagnosis of ASM, SM-AHN, or MCL confirmed by Eligibility Committee.
- Measurable disease per modified IWG-MRT-ECNM criteria.
Key Exclusion Criteria:
- Known FIP1L1-PDGFRA fusion positive.
- Substudy: Diagnosis of Philadelphia chromosome-positive malignancy or AML.
NCT06001385
For adult patients with various hematologic malignancies, including acute leukemias, myelodysplastic syndromes, lymphomas, and myelofibrosis, undergoing stem cell transplantation.
Key Inclusion Criteria:
- Diagnosis of specific hematologic malignancy (e.g., AML/ALL in remission, MDS, lymphoma).
- Receiving a partially HLA-mismatched (4/8-7/8) unrelated donor PBSC transplant.
Key Exclusion Criteria:
- Suitable HLA-matched related or 8/8 matched unrelated donor is available.
- Prior allogeneic hematopoietic stem cell transplant.
NCT04155034
A study for patients with limited or extensive stage small cell lung cancer (SCLC) who have responded to first-line therapy.
NCT05464810
A study for post-menopausal women with Stage I-III, hormone receptor-positive, HER2-negative invasive breast cancer.
Key Inclusion Criteria:
- HR+ (ER/PR >=10%) and HER2-negative invasive breast cancer
- Stage I-III disease
Key Exclusion Criteria:
- Receiving other investigational agents within 3 months
- Concomitant use of strong CYP3A4 inhibitors, cyclosporine, danazol, or gemfibrozil
NCT04192344
A study for patients with advanced solid tumors, including tenosynovial giant cell tumor (TGCT).
Key Inclusion Criteria:
- For TGCT cohort: Inoperable or surgery would cause severe morbidity.
- For TGCT cohort: Measurable disease (≥2 cm) by RECIST 1.1 via MRI.
Key Exclusion Criteria:
- Active central nervous system (CNS) metastases.
- Prior treatment with any CSF-1/CSF-1R pathway inhibitor.
NCT05978141
A registry study for patients with various types of T-cell lymphoma and NK-cell lymphoma.
NCT04104776
A study for patients with various advanced solid tumors and lymphomas, including specific cohorts for urothelial carcinoma, ovarian clear cell carcinoma, endometrial carcinoma, T-cell and B-cell lymphomas, mesothelioma, and castration-resistant prostate cancer.
Key Inclusion Criteria:
- Locally advanced or metastatic solid tumors or lymphoma.
- Specific cohorts require ARID1A mutation, BAP1 loss, EZH2 mutation, or ARID1A WT.
Key Exclusion Criteria:
- Prior treatment with an EZH2 inhibitor.
- Symptomatic untreated brain metastases.
NCT05877859
A study for patients with early-stage (Stage II-III), triple-negative invasive breast cancer.
Key Inclusion Criteria:
- Stage II-III invasive breast cancer.
- Triple-negative status (ER ≤10%, PR ≤10%, HER2-negative).
Key Exclusion Criteria:
- Receiving other investigational agents within 21 days.
- Concurrent use of steroid medications (e.g., prednisone, dexamethasone).
NCT06651580
A biospecimen collection study for pediatric patients with acute recurrent or chronic pancreatitis to identify genetic mutations that may increase the risk of pancreatic cancer.
Key Inclusion Criteria:
- Diagnosis of Acute Recurrent Pancreatitis (ARP) or Chronic Pancreatitis (CP).
- ARP: >=2 episodes of acute pancreatitis with >=1 month pain-free interval.
Key Exclusion Criteria:
- Significant medical illness that would compromise ability to participate.
NCT04762199
A study for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has an activating EGFR mutation.
Key Inclusion Criteria:
- Metastatic NSCLC with an activating EGFR mutation.
- Measurable disease (for expansion cohorts).
Key Exclusion Criteria:
- Symptomatic untreated brain metastases.
- Known interstitial lung disease or pneumonitis.
NCT04915183
For patients with squamous cell carcinoma of the head and neck scheduled to receive cisplatin-based chemoradiation with curative intent.
Key Inclusion Criteria:
- Scheduled for cisplatin-based chemoradiation with curative intent.
- Planned radiation dose to the cochlea <35 Gy.
Key Exclusion Criteria:
- Currently taking a statin drug.
- History of prior treatment with platinum chemotherapy drugs.
NCT06014658
A study for patients with advanced or metastatic solid tumors refractory to standard therapy, with specific cohorts for NSCLC, breast cancer, and other solid tumors.
Key Inclusion Criteria:
- Confirmed malignant solid tumor with no standard of care options.
- Phase 1b/2: Specific cohorts for NSCLC, breast, pancreatic, gastric, HCC, ovarian, SCC.
Key Exclusion Criteria:
- Uncontrolled CNS metastases.
- Prior MMAE-conjugated agents (for Phase 1b/2).
NCT06055439
A study of CHM-2101 CAR T-cell therapy for patients with relapsed or refractory gastrointestinal cancers, including neuroendocrine tumors, colorectal cancer, and gastric cancer.
Key Inclusion Criteria:
- Histologically confirmed gastric, colorectal adenocarcinoma, or specific GI neuroendocrine tumors.
- CDH17+ tumor expression required for gastric adenocarcinoma patients.
Key Exclusion Criteria:
- Prior treatment with any CDH17-targeted therapy.
- Known or active central nervous system (CNS) metastases.
NCT06760507
A study evaluating a family history screening program for individuals at risk for BRCA-associated cancers, such as breast and ovarian cancer.
Key Inclusion Criteria:
- Previously seen at a participating public health clinic in Southwest Georgia.
- Must be able to read English.
NCT04792489
A study for patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL), with additional cohorts for CNS lymphoma, Mantle Cell Lymphoma (MCL), and Richter's Transformation.
Key Inclusion Criteria:
- Histologically confirmed B-cell NHL (DLBCL, HGBCL, PMBCL, transformed, CNS, MCL, RT).
- Relapsed or refractory disease.
Key Exclusion Criteria:
- Prior CAR-T, allogeneic SCT, BiTE antibodies, or TCR-engineered T-cell therapy.
- Active CNS lymphoma (not applicable to CNS cohort).
NCT05368428
A study for patients with Stage I-III early-stage breast cancer who are experiencing chemotherapy-induced peripheral neuropathy.
Key Inclusion Criteria:
- At least CTCAE grade 1 CIPN in hands or feet from taxane chemotherapy.
- Actively receiving neoadjuvant or adjuvant chemotherapy with paclitaxel or docetaxel.
Key Exclusion Criteria:
- Pre-existing neuropathy.
- Implanted electronic device (e.g., pacemaker, defibrillator, pain pump).
NCT05304962
A study for patients with HR-positive, HER2-negative advanced (Stage III) or metastatic (Stage IV) breast cancer.
Key Inclusion Criteria:
- ER+/HER2- advanced (Stage III) or metastatic (Stage IV) breast cancer.
- Progression after 1 line of CDK4/6i + hormonal therapy for metastatic disease.
Key Exclusion Criteria:
- >1 prior line of chemotherapy in the metastatic setting.
- >3 prior lines of hormonal therapy.
NCT06495125
A study for patients with advanced or metastatic LKB1-mutant lung adenocarcinoma that has progressed on prior anti-PD1 immunotherapy and chemotherapy.
Key Inclusion Criteria:
- Confirmed LKB1 mutation.
- Cohort A only: Confirmed KRAS mutation.
Key Exclusion Criteria:
- Unstable or symptomatic brain metastases or leptomeningeal disease.
- Serious auto-immune toxicity from prior immune checkpoint inhibitor therapy.
NCT03547973
A study for patients with unresectable locally advanced or metastatic urothelial cancer.
Key Inclusion Criteria:
- Measurable disease per RECIST 1.1.
- Must provide archival or fresh tumor tissue for analysis.
Key Exclusion Criteria:
- Known active CNS metastases or carcinomatous meningitis.
- Active second malignancy.
NCT06064877
A study for patients with recurrent or metastatic (R/M) HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC).
Key Inclusion Criteria:
- Oropharyngeal cancer must be p16 negative.
- At least one measurable lesion per RECIST v1.1.
Key Exclusion Criteria:
- > 2 prior lines of therapy for R/M HNSCC.
- Prior treatment with cetuximab or other EGFR inhibitors.
NCT06662058
A study for patients with Head and Neck Squamous Cell Carcinoma (HNSCC) who are scheduled to receive cisplatin chemotherapy and/or radiation.
Key Inclusion Criteria:
- Pathologically proven HNSCC of specified sites or unknown primary.
- Previously untreated or recurrent/metastatic disease is allowed.
Key Exclusion Criteria:
- Profound bilateral hearing loss that precludes an accurate hearing test.
- Unable to participate in a hearing test per investigator's judgment.
NCT05873608
A study for patients with any type of cancer, including solid tumors and hematologic malignancies, who are discussing immunotherapy.
NCT03723928
A study for patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
Key Inclusion Criteria:
- HR-positive, HER2-negative metastatic (M1) breast cancer.
- Receiving or planning first-line systemic therapy for metastatic disease.
Key Exclusion Criteria:
- Known brain or leptomeningeal metastases.
- Known disease progression since Step 1 registration.
NCT05651022
A study for patients with various locally advanced or metastatic solid tumors, including specific cohorts for HCC, CRC, urothelial, SCCHN, pancreatic, NSCLC, and MSI-High cancers.
Key Inclusion Criteria:
- Part 2: HCC, CRC w/ liver mets, urothelial, SCCHN, pancreatic, NSCLC, or dMMR/MSI-H.
- Must have exhausted all available standard therapies.
Key Exclusion Criteria:
- Active or symptomatic CNS metastases; stable, treated brain mets are allowed.
- Active autoimmune disease.
NCT06541158
A study for patients with solid tumors who are receiving radiation therapy and experiencing travel barriers.
Key Inclusion Criteria:
- Documented travel barriers per 10-item Transportation Barriers Measure.
- Currently undergoing radiation therapy (RT).
Key Exclusion Criteria:
- Currently receiving palliative care.
- Enrolled in lodging programs (e.g., ACS Hope Lodge®).
NCT06799481
A study for adolescent and young adult survivors of primary brain tumors experiencing cancer-related cognitive impairment.
Key Inclusion Criteria:
- Primary brain tumor survivor treated with cranial radiotherapy.
- Completed cranial radiotherapy 6 months to 4 years prior.
Key Exclusion Criteria:
- Recurrent disease requiring re-irradiation of the brain.
- Secondary malignancies or known germline genetic syndrome.
NCT02305654
A trial for patients with squamous cell carcinoma of the penis with inguinal lymph node metastases.
Key Inclusion Criteria:
- Stage N1, N2, or N3 disease, M0.
- Histologically-proven squamous cell carcinoma of the penis.
Key Exclusion Criteria:
- Stage M1 (distant metastatic) disease.
- Prior chemotherapy or chemoradiotherapy.
NCT05642611
For patients with any solid tumor malignancy scheduled to receive taxane-based chemotherapy.
Key Inclusion Criteria:
- Scheduled for neoadjuvant/adjuvant therapy with a specified taxane-based regimen.
- Concurrent checkpoint inhibitors, trastuzumab, pertuzumab, or bevacizumab allowed.
Key Exclusion Criteria:
- Pre-existing clinical peripheral neuropathy from any cause.
- Prior neurotoxic chemotherapy (e.g., taxanes, platinums, vinca alkaloids, bortezomib).
NCT05493566
A study of low-dose interleukin-2 and pembrolizumab for patients with previously untreated Stage IV non-small cell lung cancer (NSCLC).
Key Inclusion Criteria:
- No prior therapy for advanced NSCLC.
- Tumor PD-L1 expression ≥1% or unknown status.
Key Exclusion Criteria:
- Known targetable driver mutation (e.g., EGFR, ALK).
- Known tumor PD-L1 expression of 0%.
NCT06254911
A study of pre-operative atezolizumab for patients with resectable, HPV-related Stage I oropharyngeal squamous cell carcinoma (OPSCC).
Key Inclusion Criteria:
- Histologically confirmed HPV-driven (p16+) oropharyngeal squamous cell carcinoma (OPSCC).
- Clinical Stage I (T1/2, N1) disease.
Key Exclusion Criteria:
- Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4).
- Active or history of autoimmune disease or immune deficiency.
NCT04883437
A study for patients with previously untreated follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, or mantle cell lymphoma.
NCT03666000
A study for patients with relapsed/refractory Non-Hodgkin Lymphoma (NHL) and B-cell Acute Lymphoblastic Leukemia (B-ALL).
Key Inclusion Criteria:
- Relapsed/refractory B-ALL or aggressive B-cell NHL
- CD19+ disease confirmed by morphology, flow cytometry, or MRD assay
Key Exclusion Criteria:
- Active central nervous system (CNS) disease
- Burkitt cell (L3 ALL) or mixed-lineage acute leukemia
NCT04878029
A study of cabozantinib with enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer.
Key Inclusion Criteria:
- Metastatic or unresectable locally-advanced urothelial carcinoma.
- Prior treatment with a checkpoint inhibitor (PD-1/PD-L1) required.
Key Exclusion Criteria:
- Prior treatment with cabozantinib or other MMAE-based ADCs.
- Active or untreated brain metastases.
NCT05487170
A study for patients with advanced solid tumors or diffuse large B-cell lymphoma (DLBCL).
Key Inclusion Criteria:
- Locally advanced or metastatic solid tumor or DLBCL.
- Refractory or intolerant to all available standard therapies.
Key Exclusion Criteria:
- Active CNS metastases or leptomeningeal carcinomatosis.
- Concurrent anticancer therapy.
NCT04590664
A study of verteporfin for patients with recurrent high-grade glioblastoma harboring an EGFR mutation or amplification.
Key Inclusion Criteria:
- Tumor must have EGFR mutation or amplification.
- Recurrent or progressive grade 4 glioma (glioblastoma).
Key Exclusion Criteria:
- Progression based on clinical grounds only, without MRI change.
- Edema suspected to be from late radiation effect, not true progression.
NCT03633955
A study for patients with relapsed or refractory high-risk acute leukemia (ALL, AML, ambiguous lineage) or myeloma.
Key Inclusion Criteria:
- High-risk, relapsed/refractory disease.
- Anticipated to receive either immunotherapy or standard non-HSCT therapy.
Key Exclusion Criteria:
- History of allergy or intolerance to fluorothymidine.
- Uncontrolled active infections.
NCT06650579
A study for men with advanced, non-metastatic, or recurrent prostate cancer who are planning to receive radiation therapy.
Key Inclusion Criteria:
- Non-metastatic or biochemically recurrent prostate cancer.
- Scheduled for curative-intent pelvic radiation therapy.
Key Exclusion Criteria:
- Metastatic disease requiring indefinite ADT or chemotherapy.
- Any prior androgen deprivation therapy.
NCT04620239
A study for patients with low-grade, non-invasive upper tract urothelial cancer (UTUC) in the kidney or ureter.
Key Inclusion Criteria:
- Low-grade, non-invasive UTUC (new or recurrent).
- Biopsy-proven disease with central pathology confirmation.
Key Exclusion Criteria:
- Current or prior carcinoma in situ (CIS) in the upper urinary tract.
- Current high-grade or muscle invasive (>pT1) bladder cancer.
NCT04031677
A study of surgery with or without neoadjuvant chemotherapy for patients with high-risk, resectable retroperitoneal liposarcoma or leiomyosarcoma.
Key Inclusion Criteria:
- Primary high-risk retroperitoneal/infra-peritoneal Leiomyosarcoma (LMS) or Liposarcoma (LPS).
- LPS must have MDM2/CDK4 expression; MDM2 amplification recommended.
Key Exclusion Criteria:
- Metastatic disease.
- Prior surgery, radiotherapy, or systemic therapy for the current tumor.
NCT03501576
A study evaluating immune responses to vaccination in patients with various types of lymphoma, including B-cell and T-cell non-Hodgkin lymphomas and chronic lymphocytic leukemia.
Key Inclusion Criteria:
- Diagnosis of B-NHL, CLL, MCL, or aggressive PTCL.
- Must meet specific cohort criteria regarding treatment status (e.g., on active treatment, in remission).
Key Exclusion Criteria:
- Received current seasonal influenza vaccine or had recent influenza infection.
- Known allergy to vaccine components (e.g., eggs) or history of Guillain-Barre syndrome.
NCT06534125
A study for Non-Hispanic Black postmenopausal women with Stage I-III, HR+/HER2-negative breast cancer to prevent joint pain from aromatase inhibitors.
Key Inclusion Criteria:
- Self-identified Non-Hispanic Black woman
- Must be postmenopausal
Key Exclusion Criteria:
- Metastatic (Stage IV) breast cancer
- Premenopausal status
NCT04803604
A study for family caregivers of patients with newly-diagnosed advanced cancers, including various solid tumors (brain, lung, breast, gynecologic, head/neck, GI, GU, melanoma) and hematologic malignancies.
Key Inclusion Criteria:
- Patient must have an agreeable family caregiver willing to participate.
- Advanced cancer (metastatic or recurrent/progressive Stage III/IV).
Key Exclusion Criteria:
- Documented severe mental illness (e.g., schizophrenia, bipolar, major depression).
- Documented dementia or active suicidal ideation.
NCT05391750
A study for patients with relapsed or refractory multiple myeloma who have the t(11;14) translocation.
Key Inclusion Criteria:
- Multiple myeloma positive for t(11;14) translocation by FISH.
- Relapsed/refractory to lenalidomide after >=2 cycles.
Key Exclusion Criteria:
- Prior treatment with a BCL-2 family inhibitor.
- Use of strong or moderate CYP3A inhibitors or inducers within 7 days.
NCT06636734
A study of lovastatin and pembrolizumab for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Key Inclusion Criteria:
- Recurrent or metastatic HNSCC of the oral cavity, pharynx, larynx, or sinuses.
- PD-L1 combined positive score (CPS) ≥ 1.
Key Exclusion Criteria:
- Prior treatment with immune checkpoint inhibitors.
- Currently taking a statin drug.
NCT06132685
A study for patients with high-grade glioma, low-grade glioma, meningioma, or brain metastasis undergoing craniotomy.
Key Exclusion Criteria:
- Current lymphoma or leukemia
- Known immunodeficiency (e.g., SCID, CVID)
NCT05814666
A study for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx.
Key Inclusion Criteria:
- PD-L1 expression (CPS ≥1).
- Recurrent/metastatic HNSCC incurable by local therapy.
Key Exclusion Criteria:
- Any prior therapy for metastatic HNSCC.
- Prior anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy.
NCT05103904
Recurrent, unresectable hepatocellular carcinoma (HCC) in patients who have previously received a liver transplant.
Key Inclusion Criteria:
- Recurrent, unresectable HCC after liver transplantation.
- Measurable disease per RECIST v1.1.
Key Exclusion Criteria:
- Prior systemic therapy for HCC in the post-transplant setting.
- Known brain metastases.
NCT04731376
A study for male patients with malignant urinary system neoplasms undergoing major surgery.
NCT02432560
An observational study for patients with Lymphangioleiomyomatosis (LAM) to assess the long-term safety and durability of sirolimus treatment.
Key Inclusion Criteria:
- Diagnosis of LAM based on ATS/JRS criteria.
- Eligible if on, previously failed, or considering mTOR inhibitor therapy.
Key Exclusion Criteria:
- Inability or unwillingness to perform pulmonary function testing.
- Inability to attend at least one RLD Clinic visit per year.
NCT05633615
A study of consolidation therapy for patients with relapsed/refractory Diffuse Large B-cell Lymphoma or Grade IIIB Follicular Lymphoma after receiving CAR T-cell treatment.
Key Inclusion Criteria:
- Histologically confirmed DLBCL, grade 3b FL, or PMBCL.
- Relapsed/Refractory disease, candidate for commercial CD19 CAR T-cell therapy.
Key Exclusion Criteria:
- Complete Remission (CR) on day +30 PET/CT scan post-CAR-T.
- Use of polatuzumab vedotin or mosunetuzumab as bridging therapy.
NCT04278118
A study for patients with benign intracranial or nerve sheath tumors, including meningiomas (Grades 1-3), pituitary adenomas, and schwannomas.
Key Inclusion Criteria:
- Diagnosis of meningioma (WHO grade 1-3), pituitary adenoma, or schwannoma.
- Recommended for proton or photon fractionated radiation therapy.
Key Exclusion Criteria:
- Prior radiation therapy overlapping with the current target volume.
- Inability to undergo MRI.
NCT04656496
A study for pediatric cancer survivors with overweight or obesity to promote healthy eating and exercise behaviors.
Key Inclusion Criteria:
- Must be in remission.
- BMI at or above the 85th percentile.
Key Exclusion Criteria:
- Child is non-ambulatory.
- Child is a ward of the state.
NCT05488145
A study for patients with early-stage, hormone receptor-positive, HER2-negative breast cancer to improve adherence to endocrine therapy.
Key Inclusion Criteria:
- Early-stage (Stage I-II), HR+, HER2- breast cancer.
- Completed all recommended (neo)adjuvant chemo, surgery, and/or radiation.
Key Exclusion Criteria:
- HER2-positive disease.
NCT05476770
A study for pediatric and young adult patients with various relapsed or refractory CD123-expressing hematologic malignancies, including leukemia and lymphoma.
Key Inclusion Criteria:
- Tumor cells must have surface expression of CD123.
- Diagnosis of relapsed or refractory hematologic malignancy.
Key Exclusion Criteria:
- Prior treatment with tagraxofusp.
- CNS disease excluded for Part 1; isolated CNS disease excluded for all parts.
NCT03860883
A study comparing 1cm versus 2cm surgical excision margins for patients with AJCC Stage II primary cutaneous melanoma.
Key Inclusion Criteria:
- Stage II primary invasive cutaneous melanoma (pT2b-pT4b, AJCC 8th ed.).
- Breslow thickness >1.0mm with specific ulceration status per protocol.
Key Exclusion Criteria:
- Evidence of satellite, in-transit, regional, or distant metastatic disease.
- Specific histologies: PURE desmoplastic, perineural invasion, or microsatellitosis.
NCT05394428
For female patients with primary anal, rectal, cervical, uterine, vaginal, or vulvar cancer who are planned to receive pelvic radiotherapy.
Key Inclusion Criteria:
- Primary anal, rectal, cervical, uterine, vaginal, or vulvar cancer.
- Planned to receive pelvic radiotherapy.
Key Exclusion Criteria:
- Clinically or radiologically detectable widespread metastasis.
- History of prior pelvic radiotherapy.
NCT04872478
A study for adolescents and adults with relapsed or refractory Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Mixed Phenotype Acute Leukemia (MPAL).
Key Inclusion Criteria:
- R/R AML, ALL, or MPAL (refractory to ≥1 induction or in ≥2nd relapse).
- FLT3-ITD+ expansion cohort: prior FLT3 inhibitor required.
Key Exclusion Criteria:
- Acute promyelocytic leukemia (APL/AML M3).
- Known active CNS leukemia.
NCT04725903
A study of proton radiation therapy for patients with high-risk or lymph node positive Stage III prostate cancer.
Key Inclusion Criteria:
- High-risk disease defined by one of: Gleason grade ≥8, cT3b/cT4, or PSA > 20.
- Clinically or pathologically positive regional lymph nodes.
Key Exclusion Criteria:
- Presence of bone or distant lymph node metastasis.
- Prior radical prostatectomy or cryosurgery.
NCT04908709
A study for pediatric patients with high-grade glioma of the brain.
NCT06582017
For patients with locally advanced unresectable and/or metastatic solid tumors (including ovarian, pancreatic, urothelial, renal, hepatocellular, GI, lung, prostate, and breast cancer) or multiple myeloma.
Key Inclusion Criteria:
- For MM: Failed ≥3 prior therapies, including a proteasome inhibitor, IMiD, and anti-CD38 therapy.
- For Solid Tumors: Progressed on standard therapies with no available options of known clinical benefit.
Key Exclusion Criteria:
- Significant cardiac disease (NYHA Class III/IV, recent MI, unstable arrhythmia, TdP risk).
- Active, uncontrolled infections requiring systemic therapy.
NCT04879043
A study for patients with relapsed or refractory multiple myeloma and other plasma cell disorders.
Key Inclusion Criteria:
- Prior therapy must include an IMiD, PI, and anti-CD38 antibody.
- Refractory or intolerant to established standard of care therapies.
Key Exclusion Criteria:
- Prior BCMA-targeting therapy (for Phase 2a part only).
- Known central nervous system (CNS) involvement.
NCT05271292
A study for patients with advanced solid tumors, including relapsed or refractory Small Cell Lung Cancer (SCLC).
Key Inclusion Criteria:
- Relapsed/refractory to standard therapy, or no standard therapy exists.
- At least one measurable lesion per RECIST 1.1.
Key Exclusion Criteria:
- Active or symptomatic CNS metastases requiring treatment.
- Systemic anticancer therapy within 21 days of enrollment.
NCT03391778
A long-term follow-up study for patients with various neoplasms who have previously received ADP adoptive cell therapy.
Key Inclusion Criteria:
- Received at least one dose of an ADP adoptive cell therapy agent.
- Completed or withdrew from a prior ADP-sponsored interventional study.
NCT02977468
A study for patients with newly diagnosed, early-stage, node-negative Triple Negative Breast Cancer (TNBC).
Key Inclusion Criteria:
- Triple negative receptor status (ER/PR/HER2 negative); weakly positive ER/PR (≤10%) allowed.
- Clinically node negative, non-metastatic disease.
Key Exclusion Criteria:
- Multifocal disease, lesion > 3 cm, or pathologically proven nodal disease.
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
NCT05091866
A study of natural progesterone for patients with recurrent glioblastoma or gliosarcoma.
Key Inclusion Criteria:
- Recurrent disease with >= 1 cm^3 of contrast enhancing tumor on MRI.
- Pathologically confirmed glioblastoma or gliosarcoma.
Key Exclusion Criteria:
- Active or recent (within 6 months) thromboembolic disease.
- Concurrent anti-coagulation therapy.
NCT04541108
For patients with various surface-accessible solid tumors (e.g., head and neck cancer, melanoma, sarcoma, breast cancer, lymphoma) who are scheduled for surgical intervention.
Key Inclusion Criteria:
- Planned surgical intervention for an accessible solid tumor lesion.
- At least one lesion must be surface accessible for CIVO injection.
Key Exclusion Criteria:
- Tumor is near or involves critical structures where injection poses undue risk.
- Any uncontrolled intercurrent illness or serious medical/psychiatric condition.
NCT04660760
A study for patients with previously treated, advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Key Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the stomach or GEJ.
- Locally advanced unresectable or metastatic disease.
Key Exclusion Criteria:
- Prior treatment with TAS-102 or ramucirumab.
- Prior taxane therapy within 180 days of registration.
NCT05103046
A study for patients with advanced solid tumors.
Key Inclusion Criteria:
- Measurable disease per RECIST v1.1.
Key Exclusion Criteria:
- Progressive or symptomatic brain metastases.
- History of another cancer within 3 years, with some exceptions.
NCT04137900
A study for patients with advanced unresectable or metastatic solid tumors, including lymphoma, NSCLC, melanoma, RCC, and urothelial carcinoma.
Key Inclusion Criteria:
- Histologically/cytologically confirmed advanced unresectable or metastatic solid tumor or lymphoma.
- Must have progressed following at least one line of prior therapy for advanced/metastatic disease.
Key Exclusion Criteria:
- Untreated or active CNS/leptomeningeal metastases.
- Active or prior documented autoimmune disease (with some exceptions).
NCT03838718
A registry study for patients with primary retroperitoneal sarcoma (RPS) who are undergoing surgery.
Key Inclusion Criteria:
- Diagnosis of primary retroperitoneal sarcoma (RPS).
- Histologically confirmed diagnosis by a dedicated sarcoma pathologist.
Key Exclusion Criteria:
- Recurrent retroperitoneal sarcoma.
- Benign retroperitoneal tumors.