Clinical trial · Interventional
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated
NCT03329846CI-TRIAL-00052629completedPhase 3Results 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 see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986205 | Drug | — | UNRESOLVED |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Nivolumab + Placebo
- description
- Specified dose on specified day Participants will no longer receive BMS-986205 Placebo
- interventionNames
- Biological: Nivolumab
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Nivolumab + BMS-986205
- description
- Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion
- interventionNames
- Drug: BMS-986205
- Biological: Nivolumab
Primary outcomes (1)
- measure
- Number of Participants Experiencing Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * 12 years and older unless not permitted by local regulations; in that case 18 years old and older * Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1 * Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition) * Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma) * Measurable disease per RECIST v1.1 Exclusion Criteria: * Active brain metastases or leptomeningeal metastases * Uveal or ocular melanoma * Participants with active, known, or suspected autoimmune disease * Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available
No reference posted for this study.