Phase 2
Completed N=44
Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Source: ClinicalTrials.gov NCT04349267 ↗
Enrolled (actual)
44
Serious AEs
52.3%
Results posted
Dec 2025
Primary outcomePrimary: Number of Participants With Adverse Events and Deaths — 2; 2; 3; 3 Participants
Summary
The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events and Deaths |
2; 2; 3; 3; 5; 14 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Objective Response Rate (ORR) |
0.0; 0.0; 0.0; 0.0; 0.0; 7.1 | — |
| SECONDARY Duration of Response (DoR) |
NA | — |
| SECONDARY Progression Free Survival (PFS) Rate |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of BMS-986315 |
28.8519; 51.9309; 168.2658; 283.6735; 63.1812; 160.8894 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of BMS-986315 |
2.1916; 2.5151; 1.0747; 1.8572; 1.4213; 3.5165 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of BMS-986315 |
6885.1959; 12122.1650; 41381.3449; 62500.0455; 12885.5705; 36893.5416 | — |
| SECONDARY Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) of BMS-986315 |
6345.4606; 13113.1903; 41381.3449; 62500.0455; 12885.5705; 36893.5416 | — |
| SECONDARY Concentration in a Dosing Interval (Ctau) of BMS-986315 |
4.4119; 10.7013; 33.1011; 51.1321; 10.5418; 28.3387 | — |
| SECONDARY Number of Participants With Anti-Drug Antibody (ADA) |
0; 0; 0; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1
- Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor
- Eastern cooperative oncology group performance status of 0 or 1
- Women of childbearing potential must agree to follow methods of contraception
Exclusion Criteria
- Participants with active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
- Uncontrolled or significant cardiovascular disease
- History of or with active interstitial lung disease or pulmonary fibrosis
- Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study
- History of allergy or hypersensitivity to study drug components
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT04349267). 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.