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

  • STATUS
    Recruiting
  • End date
    Aug 29, 2024
  • participants needed
    215
  • sponsor
    Bristol-Myers Squibb
Updated on 15 October 2022
BRAF
pembrolizumab
nivolumab
ipilimumab
advanced melanoma

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). It is also to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).

Details
Condition Melanoma
Treatment Ipilimumab, Relatlimab
Clinical Study IdentifierNCT03978611
SponsorBristol-Myers Squibb
Last Modified on15 October 2022

Eligibility

Yes No Not Sure

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
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
Eastern Cooperative Oncology Group (ECOG) 0-1

Exclusion Criteria

Prior treatment with ipilimumab, relatlimab, or any other cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or lymphocyte-activation gene 3 (LAG-3) targeted agents
History of uveal melanoma
Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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