TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer

Inclusion Criteria

• •Must be at least ≥ 18 years of age
• •Histologically 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
• •Oropharyngeal tumors must have p16 or human papillomavirus (HPV) testing done
• •The tumor tissues must be available and banked (- 80°C) at the time of salvage surgery (1st informed consent form \[ICF\] must be signed)
• •Recurrent 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
• •The tumors should be measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• •Must 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
• •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• •Absolute neutrophil count ≥ 1,500 cells/uL
• •Platelets ≥ 100,000/uL
• •Hemoglobin ≥ 9.0g/dL (may receive packed red blood cell \[prbc\] transfusion)
• •Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)
• •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
• •Albumin ≥ 3.0 g/dL
• •Serum creatinine ≤ 1.5 x ULN
• •Calculated creatinine clearance of ≥ 50 mL/min
• •International 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
• •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
• •Ability to understand and willingness to sign written informed consent documents
• •Female 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
• •Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion
• •Female subjects of childbearing age must have a negative serum pregnancy test at study entry
• •Patients who have received prior pembrolizumab are eligible
• •Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment
• •Use 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
• •History of severe hypersensitivity reactions to other monoclonal antibodies
• •Non-oncology vaccines within 28 days prior to planned treatment