Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Trial ID or NCT#
Status
Purpose
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
Eligibility 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
- - 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
Investigator(s)
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Contact
CCTO
650-498-7061
View on ClinicalTrials.gov