Clinical trial · Interventional
An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread
A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
- 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 the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.
Conditions
Conditions (3)
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 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986205 | Drug | — | UNRESOLVED |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Combination Therapy (Dose Escalation)
- description
- BMS 986205 + Nivolumab specified dose at specified intervals.
- interventionNames
- Drug: BMS-986205
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Combination Therapy (Dose Expansion)
- description
- BMS 986205 + Nivolumab specified dose at specified intervals.
- interventionNames
- Drug: BMS-986205
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Combination Therapy 2 (Dose Expansion)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen * During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type * Subjects must have measurable disease * Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening. * At least 4 weeks since any previous treatment for cancer * Must be able to swallow pills or capsules * Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1 Exclusion Criteria: * Active or chronic autoimmune diseases * Uncontrolled or significant cardiovascular disease * History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS) * Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma) * Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease * Active infection Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available