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Back|NCT06661720Recruiting
Official Title

Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma - STRIKE

Phase
Phase 3
Sponsor
Alliance for Clinical Trials in Oncology
Enrollment
1,040
Timeline
Mar 2025 → Nov 2037
About This Study

This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.

Eligibility Criteria

Inclusion Criteria

  • 1• Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)
  • 2Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted
  • 3Intermediate-high risk RCC:
  • 4pT2 grade 4 or sarcomatoid features, N0M0
  • 5pT3 any grade N0, M0
  • 6High-risk RCC
  • 7pT4, any grade, N0, M0
  • 8pT, any stage., any grade, N+, M0
  • 9cM1 no evidence of disease (NED) RCC
  • 10Participants who have had resection of primary tumor (radical or partical nephrectomy) and resection or definitive radiation or ablation of solid, isolated, soft tissue metastases (excluding brain and bone lesions) at the time of primary tumor removal (synchronous) or ≤1 year from primary tumor removal (metachronous)
  • 11Surgery (radical or partial nephrectomy or metastasectomy or ablation) \> 4 weeks but =\< 16 weeks prior to study registration with no ongoing complications from surgery
  • 12No evidence of disease at time of randomization as assessed by investigator by either CT or MRI scan of the brain and chest, abdomen and pelvis
  • 13No prior systemic treatment for RCC
  • 14Age \>= 18 years
  • 15Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (or Karnofsky \>= 60%)
  • 16Absolute neutrophil count (ANC) \>= 1,000/mm\^3
  • 17Platelet count \>= 100,000/mm\^3
  • 18Hemoglobin \>= 8 g/dL
  • 19Total bilirubin =\< 3 x upper limit of normal (ULN)
  • 20Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x upper limit of normal (ULN)
  • 21Calculated (calc.) creatinine clearance \>= 30 mL/min (using Cockcroft Gault equation or the estimated glomerular filtration rate from the modification of diet in renal disease trial)
  • 22Urine protein =\< 1+ on urine analysis (UA) or urine protein creatinine ration (UPCR) \< 2mg/mg
  • 23Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test is required =\< 14 days prior to registration
  • 24HIV status: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • 25Hepatitis
  • 26Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with resolved HBV infection, defined as positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antigen (HbsAg), are eligible
  • 27Hepatitis C: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • 28Cardiac Disease: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class IIB or better
  • 29No history of myocarditis
  • 30No history of clinically significant pneumonitis
  • 31No uncontrolled hypertension (systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 90 mm Hg) documented on 2 consecutive measurements taken at least 2 hours apart
  • 32No serious non-healing wound, ulcer or bone fracture within 28 days prior to registration
  • 33No serious/active infection requiring parenteral antibiotics
  • 34No moderate or severe hepatic impairment (child-Pugh B or C)
  • 35No significant bleeding disorders within 1 month prior to registration, for example:
  • 36Hematemesis, hematochezia or other gastrointestinal bleeding grade 3 or higher
  • 37Hemoptysis of pulmonary bleeding grade 3 or higher
  • 38Hematuria or other genitourinary bleeding grade 3 or higher
  • 39No history of allogeneic organ transplantation
  • 40No history of allergy of hypersensitivity to study drugs or components
  • 41No condition requiring systemic treatment with either corticosteroid (\> 10 mg daily or prednisone equivalent) within 14 days of treatment initiation or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement doses ≤10 mg daily prednisone equivalent are permitted in absence of active autoimmune disease
  • 42No active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition associated with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to registration
  • 43Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • 44No patients with a history of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids \> 10 mg/day, or immunosuppressive drugs) with the following exceptions:
  • 45Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
  • 46Brief (\<7 days) use of systemic corticosteroids is allowed when use is considered standard of care
  • 47Patients with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded
  • 48Patients requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded
  • 49Patients with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

Locations

371 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Viraj Master

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Viraj Master

Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

Recruiting

Viraj Master

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →