Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy
NCT ID: NCT02990611
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1087 participants
OBSERVATIONAL
2016-12-06
2025-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1: Nivolumab/Ipilimumab combination therapy
Participants who start a new systemic therapy with nivolumab/ipilimumab combination therapy for the first time
No interventions assigned to this group
Cohort 2: Nivolumab monotherapy
Participants who start a new systemic therapy with nivolumab monotherapy for the first time
No interventions assigned to this group
Cohort 3: Nivolumab adjuvant therapy
Participants who start adjuvant treatment with nivolumab after complete surgical tumor resection and no evidence of disease
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0001
Essen, , Germany
Countries
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Related Links
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BMS Clinical Trial Information
Other Identifiers
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CA209-654
Identifier Type: -
Identifier Source: org_study_id
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