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NCT05407675 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT05407675: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT05407675 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05407675, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.
Primary Outcome
A Dose-Limiting Toxicity (DLT) is defined as a treatment-related adverse event that meets specific severity criteria, excluding those clearly due to disease progression or unrelated causes. DLTs include: any Grade ≥3 non-hematologic toxicity (with exceptions like transient nausea, fatigue, rash, or electrolyte imbalances), significant liver enzyme elevations, Grade 4 neutropenia \>7 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding, febrile neutropenia, and any Grade ≥3 immu
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- DRUG Rabeprazole
- DRUG BMS-986408
- BIOLOGICAL Platinum-doublet chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2022-08-02 |
| Est. Completion | 2025-07-24 |
| Phase | Phase 1 |
What the finished NCT05407675 record still lists
NCT05407675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 5 interventions - of which Nivolumab is the first listed.
NCT05407675 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05407675 about?
NCT05407675 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors". The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK...
What is the current status of trial NCT05407675?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2022-08-02. Estimated completion is 2025-07-24.
What interventions are being tested in trial NCT05407675?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Rabeprazole (DRUG), BMS-986408 (DRUG), Platinum-doublet chemotherapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT05407675?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05407675's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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