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Recruiting

A Study to Assess Safety and Efficacy of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-PD-1 Treatment - CA224-083

Updated: 23 August, 2021   |   ClinicalTrials.gov

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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 34

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1: Dose Escalation Phase
Drug: Ipilimumab Drug: Relatlimab
Experimental: Part 2: Dose Expansion Phase
Drug: Ipilimumab Drug: Relatlimab

Key Eligibility Criteria

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.

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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com