Phase 2
N=229
An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread
Advanced Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03459222 ↗Enrolled (actual)
229
Serious AEs
55.5%
Results posted
Apr 2026
Primary outcome: Primary: Number of Participants With Grade 3/Grade 4 Laboratory Test Results — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Relatlimab (Biological); Nivolumab (Biological); BMS-986205 (Drug); Ipilimumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 3/Grade 4 Laboratory Test Results |
0; 0; 0; 0; 3; 1 | — |
| PRIMARY Number of Participants With Adverse Events and Deaths |
3; 3; 7; 6; 44; 54 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicities |
0; 0; 0; 0 | — |
| PRIMARY Objective Response Rate (ORR) |
23.1; 0.0; 22.2; 42.6; 23.1; 58.7 | — |
| PRIMARY Disease Control Rate (DCR) |
46.2; 33.3; 40.0; 59.3; 61.5; 76.1 | — |
| PRIMARY Duration of Response (DoR) |
NA; 18.50; NA; 21.88; NA | — |
| SECONDARY Progression Free Survival (PFS) |
2.30; 2.45; 1.87; 4.44; 3.81; NA | — |
| SECONDARY Progression Free Survival Rate at 6 and 12 Months |
30.8; 33.3; 26.0; 46.2; 40.9; 62.4 | — |
Summary
The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.
Eligibility Criteria
Inclusion Criteria
- Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
- Available tumor tissue for biomarker analysis
- Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1
Exclusion Criteria
- Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease
- History of interstitial lung disease / pneumonitis
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03459222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.