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Trial ID CA209-654  |   NCT02990611

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

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Sorry, this study is no longer accepting new participants, but is still ongoing.
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Summary

  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to describe the safety and effectiveness of nivolumab treatment, either in monotherapy or in combination with ipilimumab, overall and according to various subgroups of interest, in participants with advanced melanoma and in participants with adjuvant nivolumab therapy.

Key Eligibility Criteria

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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Cohort 1: Nivolumab/Ipilimumab combination therapy

ASSIGNED INTERVENTION

Study Arms

Cohort 2: Nivolumab monotherapy

ASSIGNED INTERVENTION

Study Arms

Cohort 3: Nivolumab adjuvant therapy

ASSIGNED INTERVENTION

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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com