Clinical trial · Interventional
An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
NCT03446040CI-TRIAL-00095354terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objectives have changed
Summary
Brief summary (as posted)
The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986258 | Biological | — | UNRESOLVED |
| Nivolumab | Biological | Nivolumab | ALIAS |
| rHuPH20 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part A Dose Escalation: BMS-986258
- interventionNames
- Biological: BMS-986258
- type
- EXPERIMENTAL
- label
- Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
- interventionNames
- Biological: BMS-986258
- Drug: rHuPH20
- type
- EXPERIMENTAL
- label
- Part B Dose Escalation: BMS-986258 + nivolumab
- interventionNames
- Biological: BMS-986258
- Biological: Nivolumab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic confirmation of one of the 5 tumors \[renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)\] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1) * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Participants 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 solid tumor histologies * Women must agree to follow specific methods of contraception, if applicable Exclusion Criteria: * Active, known or suspected autoimmune disease * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy * Other active malignancy requiring concurrent intervention Other protocol-defined inclusion/exclusion criteria apply
References
Publications (1)
- DERIVEDEl Halabi L, Adam J, Gravelle P, Marty V, Danu A, Lazarovici J, Ribrag V, Bosq J, Camara-Clayette V, Laurent C, Ghez D. Expression of the Immune Checkpoint Regulators LAG-3 and TIM-3 in Classical Hodgkin Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):257-266.e3. doi: 10.1016/j.clml.2020.11.009. Epub 2020 Nov 12. PMID 33277223