Phase 2
Completed N=281
A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Source: ClinicalTrials.gov NCT03400332 ↗Enrolled (actual)
281
Serious AEs
65.1%
Results posted
Jun 2025
Primary outcomePrimary: Number of Participants Experiencing Adverse Events (AEs) - Part 1 — 16; 14; 18; 12 Participants
Summary
The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) - Part 1 |
16; 14; 18; 12; 60; 20 | — |
| PRIMARY Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 1 |
13; 10; 13; 7; 31; 12 | — |
| PRIMARY Number of Participants Experiencing Dose Limiting Toxicities (DLTs) - Part 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 1 |
3; 2; 3; 3; 7; 1 | — |
| PRIMARY Number of Participants Who Died - Part 1 |
14; 15; 17; 10; 53; 13 | — |
| PRIMARY Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 |
2; 1; 2; 2; 7; 3 | — |
| PRIMARY Objective Response Rate (ORR) - Part 2 |
14.5; 11.7 | — |
| SECONDARY Objective Response Rate (ORR) - Part 1 |
6.3; 6.7; 16.7; 0; 3.2; 10.0 | — |
| SECONDARY Duration of Response (DOR) - Part 1 |
3.7; 28.9; 44.6; 21.09; 3.4; NA | — |
| SECONDARY Maximum Concentration (Cmax) - Part 1 |
142.91; 352.12; 779.90; 325.67; 919.44; 1227.67 | — |
| SECONDARY AUC(0-T)-Area Under Curve From Time Zero up to Last Quantifiable Concentration - Part 1 |
19594.22; 44821.39; 105171.46; 42835.41; 112123.35; 148321.77 | — |
| SECONDARY AUC(TAU)-Area Under Curve in 1 Dosing Interval - Part 1 |
21301.74; 48664.06; 106916.11; 43844.97; 113969.47; 153791.84 | — |
| SECONDARY Observed Serum Concentration at the End of a Dosing Interval (Ctau) - Part 1 |
6.81; 14.92; 23.68; 55.82; 141.89; 181.84 | — |
| SECONDARY Total Body Clearance (CLT) - Part 1 |
28.17; 24.66; 22.45; 27.37; 21.06; 23.41 | — |
| SECONDARY Average Serum Concentration Over a Dosing Interval (Css-avg) - Part 1 |
182.48; 487.85; 658.06; 397.96; 59.03; 66.87 | — |
| SECONDARY AUC Accumulation Index (AI_AUC) - Part 1 |
1.45; 1.40; 1.34; 1.19; 1.47; 1.07 | — |
| SECONDARY Cmax Accumulation Index (AI_Cmax) - Part 1 |
1.15; 1.11; 1.21; 1.15; 0.90; 1.05 | — |
| SECONDARY Ctau Accumulation Index (AI_Ctau) - Part 1 |
1.90; 1.51; 1.39; 1.10; 1.33; 1.29 | — |
| SECONDARY Effective Elimination (T-HALFeff) - Part 1 |
200.10; 202.89; 185.51; 145.15; 410.31; 222.95 | — |
| SECONDARY Time to Maximum Concentration (Tmax) - Part 1 |
3.95; 1.00; 3.81; 4.00; 4.00; 2.18 | — |
| SECONDARY Serum Trough Concentration (Ctrough) - Part 1 |
59518.0; 149309.4; 221414.7; 166358.6; 242843.4; 10711.8 | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies (ADA) - Part 1 |
0; 1; 0; 1; 1; 0 | — |
| SECONDARY Change From Baseline in Interleukin 8 (IL-8)- Part 1 |
-96.9; -37.3; -66.3; -48.2; -48.5; -82.8 | — |
| SECONDARY Progression Free Survival (PFS) - Part 2 |
2.103; 3.318 | 0.7416 |
| SECONDARY Number of Participants Experiencing Adverse Events (AEs) - Part 2 |
62; 56 | — |
| SECONDARY Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 2 |
44; 42 | — |
| SECONDARY Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 2 |
16; 23 | — |
| SECONDARY Number of Participants Who Died - Part 2 |
30; 17 | — |
| SECONDARY Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2 |
4; 6; 2; 1; 3; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
- At least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
Exclusion Criteria
- Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
- Participants with active, known or suspected autoimmune disease
- Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03400332). 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.