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Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

Trial Status: Complete

This is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of malignancy with demonstrated progression of a solid tumor (non-lymphoma) with no alternative standard-of-care therapeutic option (certain exceptions may apply).
  • At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment (certain exceptions may apply)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

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 (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.
  • Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway) (certain exceptions may apply)
  • Prior treatment with other immune modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB (CD137), OX-40, therapeutic vaccines, or cytokine treatments.
  • Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of progression by imaging for at least 6 weeks prior to the first dose of study treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases, and the patient does not require any systemic corticosteroids for management of brain metastases within 4 weeks prior to the first dose of cemiplimab (certain exceptions may apply).
  • Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE
Contact: Donald Wallace Northfelt
Phone: 507-538-7623
Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL
Contact: Crystal Lynn Placencia
Phone: 520-694-1231

California

Duarte
City of Hope Comprehensive Cancer Center
Status: COMPLETED
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Lee S. Rosen
Phone: 888-798-0719
Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: CLOSED_TO_ACCRUAL

Florida

Tampa
Moffitt Cancer Center
Status: COMPLETED

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: COMPLETED

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Tanguy Y. Seiwert
Phone: 773-834-7424

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL

Kansas

Fairway
University of Kansas Clinical Research Center
Status: CLOSED_TO_ACCRUAL
Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Joaquina Celebre Baranda
Phone: 913-588-4709
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Contact: Frank Stephen Hodi
Phone: 866-790-4500
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Frank Stephen Hodi
Phone: 866-790-4500

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: COMPLETED
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: COMPLETED

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: CLOSED_TO_ACCRUAL

New York

New York
Icahn School of Medicine at Mount Sinai
Status: COMPLETED
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: COMPLETED
Contact: Daniel Chang Cho
Phone: 212-263-4434
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE
Contact: Richard D. Carvajal
Phone: 212-639-7202

North Carolina

Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Herbert I. Hurwitz
Phone: 888-275-3853

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: COMPLETED

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: WITHDRAWN
University of Pennsylvania / Abramson Cancer Center
Status: WITHDRAWN

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: COMPLETED

Texas

Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Regeneron Pharmaceuticals, Inc.

  • Primary ID R2810-ONC-1423
  • Secondary IDs NCI-2015-00512, 2015-002132-41, s15-00061
  • Clinicaltrials.gov ID NCT02383212