Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Status: Active

Description

To estimate the clinical benefit of cemiplimab monotherapy for patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Groups 1 and 3) or with unresectable locally advanced CSCC (Group 2), or with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] treated (Group 4) as measured by overall response rate (ORR), according to central review.

Eligibility Criteria

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 and 4 only)
  • 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

Locations & Contacts

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Karl D. Lewis
Phone: 720-848-0584
Email: karl.lewis@uchsc.edu

Florida

Tampa
Moffitt Cancer Center
Status: Active
Contact: Jeffery Scott Russell
Phone: 800-456-7121
Email: canceranswers@moffitt.org

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available
University of Chicago Comprehensive Cancer Center
Status: In review
Name Not Available

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Approved
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Michael Migden
Email: mrmigden@mdanderson.org

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Regeneron Pharmaceuticals, Inc.

Trial IDs

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