Phase 2
Completed N=356
A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
Advanced Cancer
Source: ClinicalTrials.gov NCT03369223 ↗
Enrolled (actual)
356
Serious AEs
64.7%
Results posted
Nov 2025
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B — 6; 11; 10; 1 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B |
6; 11; 10; 1; 11; 12 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) Meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B |
0; 0; 1; 0; 1; 0 | — |
| PRIMARY Number of Participants Who Died - Part 1 A and 1 B |
4; 10; 7; 1; 6; 11 | — |
| PRIMARY Number of Participants With Shifts From Baseline in Laboratory Tests Results - Part 1 A and 1 B |
3; 4; 7; 1; 4; 10 | — |
| PRIMARY Number of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) Within 24 Weeks - Part 2 A Arms C, D and F, and Part 2 B |
24; 18; 14; 4; 13; 11 | — |
| PRIMARY Objective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F |
36.2; 52.8 | — |
| SECONDARY Time to Deterioration in Part 2A (Arm C, D and F) |
3.52; 4.37; 2.79 | — |
| SECONDARY Safety Related Events in Part 2A (Arm C, D and F) and 2B |
57; 57; 35; 5; 40; 45 | — |
| SECONDARY BOR of PSA and PCWG3 Response Rate in Part 2B Cohort 2 |
14.6; 9.8 | — |
| SECONDARY Progression Free Survival |
1.74; 1.77; 1.69; 3.55; 1.68; 2.33 | — |
| SECONDARY Duration of Response |
NA; 15.80; NA; NA; 26.84; NA | — |
| SECONDARY Time to Response |
2.76; 1.74; 3.48; 4.01; 2.86; 2.83 | — |
| SECONDARY Objective Response Rate (ORR) as Assessed by Investigator - Part 1 A, 1B, 2A (Arms C,D,F) and 2B |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Cmax and Ctau of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B |
398; 1451; 3569; 4965; 2735; 454 | — |
| SECONDARY AUC(0-T) and AUC(TAU) of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B |
77826; 294432; 745654; 991294; 671019; 96709 | — |
| SECONDARY Accumulation Index for Cmax (AI_Cmax) and Accumulation Index for AUC (AI_AUC) of BMS-986249 - Part 1 A and B, Part 2 A Arms C, D and F, Part 2 B |
1.29; 1.07; 0.694; 1.54; 1.23; 1.29 | — |
| SECONDARY Number of Participants With Shifts From Baseline in Laboratory Test Results - Part 2A (Arms C and F) and 2B |
42; 43; 25; 3; 32; 33 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03369223). 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.