Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Trial Status: Closed to Accrual
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
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
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
Arizona
Phoenix
Cancer Center at Saint Joseph's
Status: CLOSED_TO_ACCRUAL
Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL
California
Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Badri Modi
Phone: 626-256-4673
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL
Contact: Anne Lynn Chang
Phone: 650-721-2699
Email:
alschang@stanford.edu
San Diego
UC San Diego Medical Center - Hillcrest
Status: CLOSED_TO_ACCRUAL
Contact: Gregory Aram Daniels
Phone: 858-822-5354
Email:
cancercto@ucsd.edu
Colorado
Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Karl D. Lewis
Phone: 720-848-0584
Email:
karl.lewis@uchsc.edu
Florida
Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Jeffery Scott Russell
Phone: 800-456-7121
Email:
canceranswers@moffitt.org
Illinois
Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL
University of Chicago Comprehensive Cancer Center
Status: IN_REVIEW
Massachusetts
Boston
Beth Israel Deaconess Medical Center
Status: APPROVED
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Michigan
Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL
Contact: Leonel F. Hernandez-Aya
Phone: 800-600-3606
Email:
info@siteman.wustl.edu
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Pennsylvania
Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: COMPLETED
Texas
Houston
Utah
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL
Contact: Carolynn W. Hunter
Phone: 801-213-4299
Email:
carolynn.hunter@hci.utah.edu
Trial Phase Phase II
Trial Type Treatment
Lead Organization
Regeneron Pharmaceuticals, Inc.
- Primary ID R2810-ONC-1540
- Secondary IDs NCI-2016-00692, 2016-000105-36, s16-01239
- Clinicaltrials.gov ID NCT02760498