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Active, Not Recruiting

Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy - CA209-654

Updated: 29 March, 2021   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Cohort 1: Nivolumab/Ipilimumab combination therapy
Other: Non_Interventional
Cohort 2: Nivolumab monotherapy
Other: Non-Interventional
Cohort 3: Nivolumab adjuvant therapy
Other: Non-Interventional

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: For Cohort 1 and 2: (Recruitment ended by 02/20/2020) - Advanced melanoma (Stage III/Stage IV) - Histologically confirmed diagnosis - Treatment decision for nivolumab monotherapy or nivolumab/ipilimumab combination therapy has already been taken For Cohort 3: (Recruitment ended by 08/31/2020) - Primary diagnosis of advanced melanoma after complete surgical tumor resection and no evidence of disease - Treatment decision for adjuvant nivolumab therapy has already been taken Exclusion Criteria: For Cohort 1 and 2: (Recruitment ended by 02/20/2020) - Current primary diagnosis of a cancer other than advanced melanoma, that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator) - Previous treatment with nivolumab, for nivolumab monotherapy cohort only - Current active participation in an interventional clinical trial For Cohort 3: (Recruitment ended by 08/31/2020) - Current diagnosis of persisting advanced melanoma or a cancer other than advanced melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator) - Current active participation in an interventional clinical trial Other protocol-defined inclusion/exclusion criteria apply

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