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Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Trial Status: Active

For Groups 1 to 4, the primary objective of this study is 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. For Group 6, the primary objective is to provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced. Clinical benefit is measured by overall response rate (ORR) according to central review in each group.

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
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL
Contact: Gregory Aram Daniels
Phone: 858-822-5354

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Karl D. Lewis
Phone: 720-848-0584

Florida

Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Jeffery Scott Russell
Phone: 800-456-7121

Illinois

Chicago
Northwestern University
Status: ACTIVE
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

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
M D Anderson Cancer Center
Status: ACTIVE
Contact: Michael Migden

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin Newell Voorhies
Phone: 801-213-5242

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Regeneron Pharmaceuticals, Inc.

  • Primary ID R2810-ONC-1540
  • Secondary IDs NCI-2016-00692, s16-01239, 2016-000105-36
  • Clinicaltrials.gov ID NCT02760498