Clinical trial · Interventional
A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors
NCT04943900CI-TRIAL-00088339completedPhase 1ClinicalTrials.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, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select 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-986416 | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1A: Monotherapy (BMS-986416)
- interventionNames
- Drug: BMS-986416
- type
- EXPERIMENTAL
- label
- Part 1B: Combination Therapy (BMS-986416 + Nivolumab)
- interventionNames
- Drug: BMS-986416
- Drug: Nivolumab
Primary outcomes (6)
- measure
- Incidence of Adverse Events (AEs)
- timeFrame
- Up to 100 days after the last treatment of study intervention(s)
- measure
- Incidence of Serious Adverse Events (SAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor * Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC) * Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit * Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) * Disease amenable to serial biopsy Exclusion Criteria: * Uncontrolled or significant cardiovascular disease * Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome * Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted) Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.