Phase 2
Completed N=68
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
Source: ClinicalTrials.gov NCT05407675 ↗Enrolled (actual)
68
Serious AEs
54.4%
Results posted
Oct 2025
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Adverse Events |
3; 6; 6; 11; 3; 4 | — |
| PRIMARY Number of Participants Who Died |
0; 1; 1; 4; 0; 3 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of BMS-986408 |
2.49; 4.86; 8.56; 15.00; 15.99; 5.57 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986408 |
2.52; 4.62; 4.22; 4.28; 5.38; 4.11 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-T)] |
28.20; 78.06; 127.52; 190.26; 263.11; 21.59 | — |
| SECONDARY Objective Response Rate (ORR) Per RECIST v1.1 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Duration of Response Per RECIST v1.1 |
NA | — |
Eligibility Criteria
Inclusion Criteria
- Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
- Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
- Participants must have experienced radiographically documented progressive disease on or after the most recent therapy
Exclusion Criteria
- An active, known or suspected autoimmune disease
- Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
- Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug
- Untreated central nervous system (CNS) metastases or leptomeningeal metastasis
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT05407675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.