A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients with Advanced Cutaneous Squamous Cell Carcinoma (CSCC)

To estimate the clinical benefit of REGN2810 monotherapy for patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Group 1) or with unresectable locally advanced CSCC (Group 2), as measured by overall response rate (ORR), according to central review.

Key Inclusion Criteria:

* At least 1 measurable lesion

* 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. Examples of immune modulating 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
Phase II
Oral, Head and Neck
Rom Leidner, M.D.
Regeneron Pharmaceuticals, Inc.
George Morris
  • Oncology and Hematology Care Eastside