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) of relatlimab in combination with ipilimumab.
Phase
N/AInclusion 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
- 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
- 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 cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or lymphocyte-activation gene 3 (LAG-3) targeted agents
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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