Phase 3
Completed N=20
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
Source: ClinicalTrials.gov NCT03329846 ↗Enrolled (actual)
20
Serious AEs
40.0%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants Experiencing Adverse Events — 0; 0; 3; 3 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Adverse Events |
0; 0; 3; 3; 1; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03329846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.