Clinical trial · Interventional
A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors
A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
NCT05888831CI-TRIAL-00090884active not recruitingPhase 1 / Phase 2ClinicalTrials.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 evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with 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 Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986449 | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Escalation: BMS-986449 monotherapy
- interventionNames
- Drug: BMS-986449
- type
- EXPERIMENTAL
- label
- Dose Escalation: BMS-986449 + nivolumab
- interventionNames
- Drug: BMS-986449
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts
- interventionNames
- Drug: BMS-986449
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant. * Part 1A may have a solid malignancy of any histology. * Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC). * Part 1C is restricted to participants with Triple-negative breast cancer (TNBC). * Tumor biopsy must be obtained for all participants (unless medically precluded). Exclusion Criteria: * History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 \[CTLA-4\], or anti-PD- 1/programmed death-ligand 1 \[PD-L1\] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures. * Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention. * Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator. Other protocol-defined criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.