For Healthcare Professionals

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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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

For Cohort 1 and 2: (Recruitment ended by 02/20/2020)

  1. Advanced melanoma (Stage III/Stage IV)
  2. Histologically confirmed diagnosis
  3. Treatment decision for nivolumab monotherapy or nivolumab/ipilimumab combination therapy has already been taken For Cohort 3: (Recruitment ended by 08/31/2020)
  4. Primary diagnosis of advanced melanoma after complete surgical tumor resection and no evidence of disease
  5. Treatment decision for adjuvant nivolumab therapy has already been taken

EXCLUSION CRITERIA

For Cohort 1 and 2: (Recruitment ended by 02/20/2020)

  1. 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)
  2. Previous treatment with nivolumab, for nivolumab monotherapy cohort only
  3. Current active participation in an interventional clinical trial For Cohort 3: (Recruitment ended by 08/31/2020)
  4. 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)
  5. Current active participation in an interventional clinical trial Other protocol-defined inclusion/exclusion criteria apply
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
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Study’s details


Contition

Melanoma

Age (in years)

18 - 200

Participants needed

1087

Est. Completion Date

Aug 2025

Treatment type

Observational


Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov identifier

NCT02990611

Study number

CA209654

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