Clinical trial · Interventional
A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
NCT03400332CI-TRIAL-00103914completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986253 | Drug | — | UNRESOLVED |
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Part 1A: BMS-986253 + nivolumab
- interventionNames
- Drug: BMS-986253
- Biological: Nivolumab
- type
- EXPERIMENTAL
- label
- Part 1B: BMS-986253 + nivolumab
- interventionNames
- Drug: BMS-986253
- Biological: Nivolumab
- type
- EXPERIMENTAL
- label
- Part 1C: BMS-986253 + nivolumab + ipilimumab
- interventionNames
- Drug: BMS-986253
- Biological: Nivolumab
- Biological: Ipilimumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1 * At least 1 lesion accessible for biopsy * Eastern Cooperative Oncology Group Performance Status of 0 or 1 Exclusion Criteria: * Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll) * Participants with active, known or suspected autoimmune disease * Participants with conditions requiring systemic treatment with either corticosteroids (\> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration * Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS) * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy Other protocol defined inclusion/exclusion criteria could apply
References
Publications (1)
- DERIVEDCai S, Wei X, Li Q, Jiang Z, Li L. Smart materials in pharmacological drug development: Neutrophils and its constituents for drug delivery and consequent antitumor effects. Mol Immunol. 2025 Jul;183:18-32. doi: 10.1016/j.molimm.2025.04.010. Epub 2025 May 2. PMID 40318595