Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Not Recruiting

Trial ID: NCT02760498


Groups 1 to 4 To estimate the clinical benefit of cemiplimab monotherapy for patients with: metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC Group 6 To provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced treated with cemiplimab

Official Title

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

Stanford Investigator(s)

Anne Lynn S. Chang, MD
Anne Lynn S. Chang, MD

Professor of Dermatology

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


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 CSCC lesions (Groups 2, 4, and 6)

   - 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 cemiplimab, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, 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 cemiplimab

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of non-infectious pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody

   - 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

Other protocol-defined inclusion/exclusion criteria apply


drug: cemiplimab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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