A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment
- Registration Number
- NCT03978611
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1: Dose Escalation Phase Relatlimab - Part 1: Dose Escalation Phase Ipilimumab -
- Primary Outcome Measures
Name Time Method Number of Participants with AEs resulting in Death Up to end of study (approximately 2.4 years) Number of Participants with AEs resulting in Discontinuation Up to end of study (approximately 2.4 years) Number of Participants with Serious Adverse Events (SAEs) 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 Up to 28 days after last study drug dose (approximately up to 2 years) Number of Participants with Adverse Events (AEs) 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 Up to end of study (approximately 2.4 years)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Local Institution - 0002
🇺🇸Los Angeles, California, United States
Local Institution - 0018
🇧🇪Bruxelles, Brussels, Belgium
Local Institution - 0016
🇧🇪Brussels, Belgium
Local Institution - 0037
🇩🇪Erlangen, Germany
Local Institution - 0036
🇩🇪Gera, Germany
Local Institution - 0035
🇩🇪Hannover, Germany
Local Institution - 0032
🇩🇪Lübeck, Germany
Local Institution - 0004
🇺🇸Chicago, Illinois, United States
Local Institution - 0023
🇺🇸Tucson, Arizona, United States
Local Institution - 0005
🇺🇸Los Angeles, California, United States
Local Institution - 0001
🇺🇸Santa Monica, California, United States
Local Institution - 0044
🇨🇦Ottawa, Ontario, Canada
Local Institution - 0034
🇩🇪Essen, Germany
Local Institution - 0040
🇩🇪Nuremberg, Germany
Local Institution - 0033
🇩🇪Heidelberg, Germany
Local Institution - 0053
🇮🇹Padova, Italy
Local Institution - 0026
🇪🇸Barcelona, Spain
Local Institution - 0055
🇮🇹Siena, Italy
Local Institution - 0027
🇪🇸Hospitalet de Llobregat - Barcelona, Spain
Local Institution - 0030
🇪🇸Cordoba, Spain
Local Institution - 0031
🇪🇸San Sebastian, Spain
Local Institution - 0029
🇪🇸Madrid, Spain
Local Institution - 0028
🇪🇸Valencia, Spain
Local Institution - 0015
🇺🇸Miami, Florida, United States
Local Institution - 0003
🇺🇸Ann Arbor, Michigan, United States
Local Institution - 0017
🇧🇪Antwerpen, Belgium
Local Institution - 0038
🇧🇪Bruxelles, Belgium
Local Institution - 0008
🇺🇸Morristown, New Jersey, United States