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
Overview
- Phase
- Phase 1
- Intervention
- Relatlimab
- Conditions
- Melanoma
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 11
- Locations
- 28
- Primary Endpoint
- Number of Participants with AEs resulting in Death
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
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
- •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
- •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
Arms & Interventions
Part 1: Dose Escalation Phase
Intervention: Relatlimab
Part 1: Dose Escalation Phase
Intervention: Ipilimumab
Outcomes
Primary Outcomes
Number of Participants with AEs resulting in Death
Time Frame: Up to end of study (approximately 2.4 years)
Number of Participants with AEs resulting in Discontinuation
Time Frame: Up to end of study (approximately 2.4 years)
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Number of Participants With Adverse Events Including Dose Limiting Toxicity
Time Frame: Up to 28 days after last study drug dose (approximately up to 2 years)
Number of Participants with Adverse Events (AEs)
Time Frame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Number of Participants with AEs resulting in Laboratory Abnormalities
Time Frame: Up to end of study (approximately 2.4 years)