Clinical trial · Interventional
An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors
NCT02598960CI-TRIAL-00064477completedPhase 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
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.
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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986156 | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- BMS-986156: Dose Escalation
- interventionNames
- Drug: BMS-986156
- type
- EXPERIMENTAL
- label
- BMS-986156 + nivolumab (nivo): Dose Escalation
- interventionNames
- Drug: BMS-986156
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- BMS-986156: Dose Expansion
- interventionNames
- Drug: BMS-986156
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * For Dose Escalation: * Subjects with any previously treated advanced (metastatic or refractory) solid tumor * For Cohort Expansion: * Subjects must have a previously treated advanced solid tumor to be eligible * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy * Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men Exclusion Criteria: * Known central nervous system metastases or central nervous system as the only source of disease * Other concomitant malignancies (with some exceptions per protocol) * Active, known or suspected autoimmune disease * Uncontrolled or significant cardiovascular disease * History of active or chronic hepatitis (e.g. Hep B or C) * Impaired liver or bone marrow function * Major surgery less than 1 month before start of the study
References
Publications (2)
- DERIVEDWang R, Baxi V, Li Z, Locke D, Hedvat C, Sun Y, Walsh AM, Shao X, Basavanhally T, Greenawalt DM, Patah P, Novosiadly R. Pharmacodynamic activity of BMS-986156, a glucocorticoid-induced TNF receptor-related protein agonist, alone or in combination with nivolumab in patients with advanced solid tumors. ESMO Open. 2023 Apr;8(2):100784. doi: 10.1016/j.esmoop.2023.100784. Epub 2023 Feb 28. PMID 36863094
- DERIVEDHeinhuis KM, Carlino M, Joerger M, Di Nicola M, Meniawy T, Rottey S, Moreno V, Gazzah A, Delord JP, Paz-Ares L, Britschgi C, Schilder RJ, O'Byrne K, Curigliano G, Romano E, Patah P, Wang R, Liu Y, Bajaj G, Siu LL. Safety, Tolerability, and Potential Clinical Activity of a Glucocorticoid-Induced TNF Receptor-Related Protein Agonist Alone or in Combination With Nivolumab for Patients With Advanced Solid Tumors: A Phase 1/2a Dose-Escalation and Cohort-Expansion Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):100-107. doi: 10.1001/jamaoncol.2019.3848. PMID 31697308