An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer Receiving REGN2810 (Anti-PD-1)

Key Inclusion Criteria:

• Histologically confirmed diagnosis of recurrent and/or metastatic SCCHN (squamous cell carcinoma of the head and neck) with no curative options with at least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and accessible for biopsies. Primary tumor sites of oral cavity, oropharynx, larynx, or hypopharynx are included.
• Have failed/are refractory to at least first line chemotherapy OR deemed unsuitable candidate for first line chemotherapy due to medical co-morbidities or patient preference
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• Adequate hepatic function
• Adequate renal function
• Adequate bone marrow function
• Provide signed informed consent
• Willing and able to comply with clinic visits and study-related procedures

Key Exclusion Criteria:

• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse event (irAEs)
• Prior treatment with an agent that blocks the programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) pathway
• Prior treatment with other immune modulating anti-cancer agents
• Untreated or active brain metastases or spinal cord compression
• Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of REGN2810
• Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria will apply