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A Study to Assess Safety and Efficacy of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-PD-1 Treatment

Trial Status: Active

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine the recommended dose of relatlimab in combination with ipilimumab (for dose escalation) and to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).

Inclusion Criteria

  • Must have documented progression while on a prior anti-programmed cell death protein 1 (PD-1) containing regimen limited to Nivolumab or Pembrolizumab.
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test
  • Participants must have histologically confirmed advanced unresectable (Stage III) or metastatic (Stage IV) melanoma, as per AJCC staging system
  • Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses.
  • BRAF wild type and mutant participants are eligible
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Ability to comply with treatment, patient-reported outcomes (PROs), PK, and pharmacodynamic sample collection and required study follow-up

Exclusion Criteria

  • History of uveal melanoma
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
  • Prior treatment with ipilimumab, relatlimab, or any other CTLA-4 or LAG-3 targeted agents
  • Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 and HIV-2 antibody.

California

Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Charlean Ketchens
Phone: 323-865-3035
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Charlean Ketchens
Phone: 323-865-3035
Newport Beach
Hoag Memorial Hospital
Status: ACTIVE
Contact: Cristina de Leon
Phone: 949-764-5543

Illinois

Chicago
Northwestern University
Status: ACTIVE

Texas

San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: IN_REVIEW
Contact: Sonia Lisa Creighton
Phone: 210-450-1366

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA224-083
  • Secondary IDs NCI-2019-06903, 2019-000132-25
  • Clinicaltrials.gov ID NCT03978611