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A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy

Description

Brief Summary
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).


Phase

N/A

Inclusion and Exclusion 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

  • 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.

Sites

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