Clinical Trials

Key Inclusion Criteria:

• At least 1 measurable lesion
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Adequate bone marrow function
• Adequate renal function
• Adequate hepatic function
• Archived or newly obtained tumor material
• Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2 only)
• Surgical or radiological treatment of lesions contraindicated

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 events
• Prior treatment with an agent that blocks the PD-1/PD-L1pathway
• Prior treatment with a BRAF inhibitor
• Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to the first dose of REGN2810, or associated with immune-mediated adverse events that were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with toxicity that resulted in discontinuation of the immune-modulating agent. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.
• Untreated brain metastasis(es) that may be considered active
• Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
• Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus
• History of pneumonitis within the last 5 years
• Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
• Known allergy to doxycycline or tetracycline
• Patients with a history of solid organ transplant
• Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that renders the patient unsuitable
• Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply