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Official Title
Phase 1b Study of TMV Vaccine Therapy Alone and TMV Vaccine Plus Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Phase
Phase 1
Sponsor
Emory University
Enrollment
12
Timeline
May 2025 → Jan 2027
About This Study
This phase Ib trial tests the safety, side effects and best dose of tumor membrane vesicle (TMV) vaccine therapy alone and in combination with pembrolizumab and evaluates how well it works in treating patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Vaccines made from a person's tumor cells, such as TMV vaccines, may help the body build an effective immune response to kill tumor cells. 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. Giving TMV vaccine therapy alone or with pembrolizumab may be safe, tolerable and/or effective in treating patients with recurrent and/or metastatic head and neck squamous cell cancer.
Eligibility Criteria
Inclusion Criteria
- 1Must be at least ≥ 18 years of age
- 2Histologically proven squamous cell carcinoma of the head and neck (HNSCC), amenable to salvage surgery. p16 positive and negative allowed. Squamous cell carcinoma of the oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, sinonasal carcinoma and cancer of unknown primary (squamous cell carcinoma only) are all allowed. They will be allowed to have up to 3 different regimens after diagnosed of recurrent or metastatic HNSCC
- 3Oropharyngeal tumors must have p16 or human papillomavirus (HPV) testing done
- 4The tumor tissues must be available and banked (- 80°C) at the time of salvage surgery (1st informed consent form \[ICF\] must be signed)
- 5Recurrent and/or metastatic HNSCC that has failed standard chemotherapy and immunotherapy. Eligible subjects must have progressed on ≥ 2 lines of standard of care prior to starting trial therapy. For patients who have relapsed within 6 months of systemic therapy given with curative intent, that therapy will count as a line of metastatic therapy. Eligible subjects will have no restriction on prior lines of therapy in the metastatic/advanced disease setting
- 6The tumors should be measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- 7Must have enough tissue collected after salvage surgery to make at least 3 doses of vaccine (minimum weight of the resectable tumor tissue is ≥ .5 grams) and adequate cellularity (\> 40% cellularity) assessed by the head and neck pathologists
- 8Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- 9Absolute neutrophil count ≥ 1,500 cells/uL
- 10Platelets ≥ 100,000/uL
- 11Hemoglobin ≥ 9.0g/dL (may receive packed red blood cell \[prbc\] transfusion)
- 12Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)
- 13Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- 14Albumin ≥ 3.0 g/dL
- 15Serum creatinine ≤ 1.5 x ULN
- 16Calculated creatinine clearance of ≥ 50 mL/min
- 17International normalized ratio (INR) ≤ 1.5. Anticoagulation is allowed only with low molecular weight heparin (LMWH). Patient receiving low molecular weight (LMW) heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level \< 1.1U/mL are allowed on the trial
- 18Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- 19Ability to understand and willingness to sign written informed consent documents
- 20Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion
- 21Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion
- 22Female subjects of childbearing age must have a negative serum pregnancy test at study entry
- 23Patients who have received prior pembrolizumab are eligible
Exclusion Criteria
- 1Salivary tumors and non-squamous cell histology in head and neck cancer
- 2Not enough tissue collected after surgery for a planned 3 doses (weight of the resectable tumor tissue is less than 1.0 gram)
- 3Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
- 4Prior organ allograft or allogeneic bone marrow transplantation
- 5Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
- 6Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- 7Women who are pregnant or lactating, and child-bearing potential women without adequate contraception
- 8Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- 9Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
- 10Clinical evidence of bleeding diathesis or coagulopathy
- 11Patients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for \> 5 years. Patients with prior in situ carcinomas are eligible provided there was complete removal
- 12Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment
- 13Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration
- 14History of severe hypersensitivity reactions to other monoclonal antibodies
- 15Non-oncology vaccines within 28 days prior to planned treatment
Locations
2 sites participating in this study
Emory University Hospital Midtown
Atlanta, Georgia 30308
Dong M. Shin, MD, FACP, FAAAS
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Dong M. Shin, MD, FACP, FAAAS
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →