A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
Sponsor: Bristol-Myers Squibb
Sponsor score: 60
ClinicalTrials ID:NCT03470922
This study evaluates the efficacy of relatlimab combined with nivolumab versus nivolumab alone in treating unresectable or metastatic melanoma. Eligible participants must have Stage III or IV melanoma, no prior systemic therapy, and provide tumor tissue for biomarker analysis. Interventions include specified doses of relatlimab and nivolumab.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab monotherapy in treating unresectable melanoma or melanoma that has spread.
Eligibility Criteria
Inclusion Criteria
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
- Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
- Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
Exclusion Criteria
- Participants must not have active brain metastases or leptomeningeal metastases
- Participants must not have uveal melanoma
- Participants must not have an active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0010 | 85724-5024 | Tucson | Arizona |
| Local Institution - 0020 | 90095 | Los Angeles | California |
| Coastal Integrative Cancer Care | 93401 | San Luis Obispo | California |
| Local Institution - 0116 | 93105 | Santa Barbara | California |
| Local Institution - 0012 | 20007 | Washington D.C. | District of Columbia |
| Local Institution - 0013 | 32224 | Jacksonville | Florida |
| Local Institution - 0117 | 32806 | Orlando | Florida |
| Local Institution - 0007 | 33612 | Tampa | Florida |
| Local Institution - 0038 | 30342 | Atlanta | Georgia |
| Local Institution - 0016 | 60611 | Chicago | Illinois |
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