Trial Search Results

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals


  • Drug: cemiplimab


Phase 2


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting