Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
Search Study Connect

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: 25 April, 2022   |   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
Cohort 2: Nivolumab monotherapy
Cohort 3: Nivolumab adjuvant 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Email Us

Have questions?
Email Us