Status:
COMPLETED
A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
Up to 18 years
Brief Summary
The purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metas...
Eligibility Criteria
Inclusion
- Participants with confirmed diagnosis of unresectable or metastatic cutaneous melanoma, or stage IIB-IV cutaneous melanoma who have undergone complete resection
- Initiated treatment with nivolumab monotherapy or in combination with ipilimumab for unresectable or metastatic melanoma, or as adjuvant therapy for resected stage IIb-IV melanoma, between January 1, 2015 and 6 months prior to data collection
- For the adjuvant nivolumab cohort, initiated treatment with nivolumab for stage IIb-IV melanoma within 12 weeks following index resection
- Aged \<18 years at the time of nivolumab/ipilimumab treatment initiation
- At least 6 months of follow-up from index treatment date (unless deceased prior to end of 6 months)
Exclusion
- Prior malignancy active within 3 years prior to nivolumab or ipilimumab treatment index date except for locally curable cancers that have been apparently cured (such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast)
- Receiving nivolumab therapy (monotherapy, combination with ipilimumab, or adjuvant therapy) for melanoma as part of a clinical trial during the study period
Key Trial Info
Start Date :
August 14 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 10 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06163170
Start Date
August 14 2023
End Date
November 10 2023
Last Update
April 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardinal Health
Dublin, Ohio, United States, 43017