Status:
ACTIVE_NOT_RECRUITING
A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief Summary
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
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
April 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2030
Estimated Enrollment :
714 Patients enrolled
Trial Details
Trial ID
NCT03470922
Start Date
April 11 2018
End Date
December 15 2030
Last Update
September 9 2025
Active Locations (127)
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1
Local Institution - 0010
Tucson, Arizona, United States, 85724-5024
2
Local Institution - 0020
Los Angeles, California, United States, 90095
3
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
4
Local Institution - 0116
Santa Barbara, California, United States, 93105