Clinical trial · Interventional
First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors
Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors
NCT03110107CI-TRIAL-00088848terminatedPhase 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-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid 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-986218 | Biological | — | UNRESOLVED |
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Part 1A: Monotherapy (BMS-986218)
- interventionNames
- Biological: BMS-986218
- type
- EXPERIMENTAL
- label
- Part 1B: Combination Therapy (BMS-986218 + Nivolumab)
- interventionNames
- Biological: BMS-986218
- Biological: Nivolumab
- type
- EXPERIMENTAL
- label
- Part 2A: Monotherapy (BMS-986218 OR Ipilimumab)
- interventionNames
- Biological: Ipilimumab
- Biological: BMS-986218
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists * Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A) * Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B \& 2C) * Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D) Exclusion Criteria: * Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy * Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.