A Phase II Study of Pembrolizumab in Combination With Circulating Tumor DNA Response-Adaptive Pulsed Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: The SINERGY Trial (Squamous Cell Carcinoma of Head and Neck Response-Guided Therapy)
By doing this study, the research team would like to learn if using a blood test that measures the amount of tumor DNA in blood can help guide how to use chemotherapy combined with immunotherapy for individuals with head and neck cancer. Using this blood test, the research team hopes to learn if intermittent (occasional) chemotherapy added to immunotherapy will work better than immunotherapy alone. Participation in this research will last about two years.
• Have clinically confirmed head and neck cancer that is recurrent (comes back/returns to the body) or metastatic (spreads to other parts of the body).
• Participants should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 3 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed.
• Greater than or equal to 18 years old.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Have measurable disease based on RECIST 1.1 as determined by the site. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Participants must have normal organ and marrow function as defined by clinical lab values.
• Participants must have provided tissue for programmed cell death ligand 1 (PD-L1) biomarker analysis from a core or excisional biopsy (fine needle aspirate is not adequate). Repeat samples may be required if adequate tissue is not provided. A newly obtained biopsy (within 90 days prior to start of study treatment) is strongly preferred, but an archival sample is acceptable.
• Measurable disease (either primary site and/or nodal disease) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
• Participants must sign a study-specific informed consent form prior to study entry. Participants should have the ability to understand and the willingness to sign a written informed consent document.
• Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
• Women must not be breastfeeding.
• Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment.
• Men who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).