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©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT02760498
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
Professor of Dermatology
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
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
Other protocol-defined inclusion/exclusion criteria apply
drug: cemiplimab
Not Recruiting
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