Clinical trial · Interventional
A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
NCT03369223CI-TRIAL-00097329completedPhase 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 determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986249 | Biological | — | UNRESOLVED |
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (11)
- type
- EXPERIMENTAL
- label
- Part 1A: BMS-986249
- interventionNames
- Biological: BMS-986249
- type
- EXPERIMENTAL
- label
- Part 1B: BMS-986249 + nivolumab (nivo)
- interventionNames
- Biological: BMS-986249
- Biological: Nivolumab
- type
- EXPERIMENTAL
- label
- Part 2A Arm C: BMS-986249 + nivo
- description
- Previously untreated unresectable stage III-IV melanoma
- interventionNames
- Biological: BMS-986249
- Biological: Nivolumab
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 or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed. * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists * Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants * Willing and able to comply with all study procedures Exclusion Criteria: * Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded * Other active malignancy requiring concurrent intervention * Prior organ allograft * Active, known, or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.