Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Advanced Cutaneous Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Advanced Cutaneous Squamous Cell Carcinoma focused on measuring Metastatic CSCC, Unresectable locally advanced CSCC
Eligibility Criteria
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
Sites / Locations
- University of Arizona Cancer Center
- Mayo Clinic
- City of Hope Hospital
- University of California, Los Angeles
- Stanford University
- University of California, San Diego
- University of Colorado, Denver
- Mount Sinai Comprehensive Cancer Center
- H. Lee Moffitt Cancer Center
- Northwestern University
- Norton Cancer Institute
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- Barbara Ann Karmanos Cancer Institute
- St. Louis University
- Washington University in St. Louis
- Nebraska Methodist Hospital
- New York University
- Memorial Sloan Kettering Cancer Center
- University of Rochester Medical Center
- Cleveland Clinic
- St. Luke's Hematology Oncology Specialists
- Penn State Hershey Medical Center
- Dermatology and Laser Center of Charleston
- MD Anderson Cancer Center
- Huntsman Cancer Institute
- The Canberra Hospital
- Gosford Hospital
- Royal North Shore Hospital
- Calvary Mater Newcastle
- Royal Brisbane & Women's Hospital
- Princess Alexandra Hospital
- Adelaide Cancer Centre
- Peter MacCallum Cancer Centre
- Border Medical Oncology
- Sir Charles Gairdner Hospital
- Hospital de Clinicas de Porto Alegre
- Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
- Fundação São Francisco Xavier-Hospital Márcio Cunha
- Animi
- Instituto do Cancer do Estado de São Paulo ICESP
- Fundação Antônio Prudente - AC Camargo Câncer Center
- Hôpital Claude Huriez
- Hopital Avicenne
- Hôpital Saint-André
- CHU Dijon Bourgogne
- CHRU Grenoble
- Hopitaux de La Timone
- Centre Hospitalier Universitaire de Nantes
- Hopital Cochin
- Hôpital Saint Louis
- Centre Hospitalier Lyon Sud
- Institut Gustave Roussy
- Universitätsklinikum Tübingen
- LMU Klinikum der Universität München
- Medizinische Hochschule Hannover
- Universitätsklinikum Essen
- Universitätsklinikum Carl Gustav Carus
- Universitatsklinikum Schleswig-Holstein
- Charitè Campus Mitte
- SRH Wald-Klinikum Gera
- Andreas Sygros Hosptial-University of Athen
- Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
- Istituto Oncologico Veneto - I.R.C.C.S.
- ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
- Ospedale San Salvatore
- Istituto Europeo Di Oncologia
- Fondazione Policlinico Universitario A Gemelli
- ICO l'Hospitalet - Hospital Duran i Reynals
- Hospital Clinic de Barcelona
- Hospital Universitario Vall d'Hebron
- Hospital Universitario Germans Trias i Pujol
- C.H. Regional Reina Sofia - PPDS
- Hospital Universitario Ramon y Cajal
- Hospital Universitario Fundacion Jimenez Diaz
- Hospital Universitario 12 de Octubre
- Hospital Universitario Marques de Valdecilla
- Fundacion Instituto Valenciano de Oncología
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Group 1
Group 2
Group 3
Group 4
Group 6
Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously (IV) every 2 weeks (Q2W).
Patients with unresectable locally advanced CSCC. Cemiplimab administered IV Q2 weeks.
Patients with metastatic CSCC to distant sites or lymph nodes. Cemiplimab administered IV Q3 weeks.
Patients with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] Cemplimab administered IV Q4 weeks.
Patients with advanced CSCC (metastatic [nodal or distant] or locally advanced) who received cemiplimab IV Q3W for at least 27 weeks without experiencing disease progression, will have the option to receive cemiplimab by subcutaneous (SC) injection Q3W (first 12 patients) or Q6W (next ≥ 6 patients) basis.