Phase 2
Completed N=101
A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
Broad Solid Tumor
Source: ClinicalTrials.gov NCT02913313 ↗
Enrolled (actual)
101
Serious AEs
55.5%
Results posted
Apr 2025
Primary outcomePrimary: Number of Participants With Adverse Events — 1; 2; 3; 4 Participants
Summary
The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
1; 2; 3; 4; 8; 4 | — |
| PRIMARY Number of Participants Who Died |
1; 0; 3; 1; 1; 1 | — |
| PRIMARY Part 1A, 1B and 1C and 2A: Number of Participants With Dose Limiting Toxicities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities |
0; 0; 0; 0; 2; 0 | — |
| PRIMARY Part 2C: Objective Response Rate (ORR) |
20.0 | — |
| PRIMARY Part 2C: Duration of Response (DOR) |
NA | — |
| PRIMARY Part 2C: Progression Free Survival Rate at Week 24 |
80.0 | — |
| SECONDARY Objective Response Rate (ORR) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Duration of Response |
NA; NA; NA | — |
| SECONDARY Progression Free Survival Rate at Week 24 |
100.0; 100.0; 66.7; 100.0; 75.0; 100.0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of BMS-986207 |
4952; 27291; 78548; 249112; 439192; 259914 | — |
| SECONDARY BMS-986207 Time to Maximum Concentration (Tmax) |
2.20; 1.07; 1.00; 1.29; 1.59; 1.11 | — |
| SECONDARY BMS-986207 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T)) |
903246; 4040645; 11778859; 39736190; 66647788; 33053505 | — |
| SECONDARY BMS-986207 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU) |
903246; 4040645; 11778859; 42372351; 66647788; 36019071 | — |
| SECONDARY BMS-986207 Observed Serum Concentration at the End of a Dosing Interval (Ctau) |
1657; 6526; 20264; 79783; 118571; 51893 | — |
| SECONDARY BMS-986207 Total Body Clearance (CLT) |
0.014; 0.009; 0.011; 0.011; 0.011; 0.011 | — |
| SECONDARY BMS-986207 Average Concentration Over a Dosing Interval (Css-avg) |
4281; 25746; 64581; 225882; 451954; 209969 | — |
| SECONDARY BMS-986207 Ratio of an Exposure Measure at Steady State to That After the First Dose (AI_TAU) |
1.42; 2.00; 1.94; 1.91; 2.04; 1.97 | — |
| SECONDARY BMS-986207 Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (T-HALFeff) |
189; 334; 319; 306; 344; 338 | — |
| SECONDARY Number of Participants With Positive Anti-BMS-986207-Antibodies Results |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization
Exclusion Criteria
- Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll
- Other active malignancy requiring concurrent intervention
- Uncontrolled or significant cardiovascular disease
- Active, known, or suspected autoimmune disease
- NSCLC without prior treatment in the advanced or metastatic setting (Part 2C)
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02913313). 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.