A Retrospective Observational Study on the Long-term Effects of Ipilimumab-treated Pediatric Participants in the Dutch Melanoma Treatment Registry (DMTR)
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT04196452
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Ipilimumab — DRUGSpecified dose on specified days
Study Details
This is an observational, national, retrospective study consisting of pediatric patients with advanced (spread or unremoveable) melanoma identified in the DMTR in the Netherlands
Key Dates
- Start date
- Aug 12, 2019
- Status verified
- Nov 2025
- Primary completion
- Feb 20, 2034
- Completion
- Jul 24, 2034
Study Design
- Enrollment
- 10 participants (estimated)
Arms
- Arm: Arm A: participants 12 to under 18
- Arm: Arm B: participants under 12
Primary Outcome Measure
Frequency of Adverse Events (AEs) Grades 3-4 [ Time Frame: up to 10 years ]
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- Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of MelanomaRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- Harvesting Cells for Experimental Cancer TreatmentsEnrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland
- Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch StudiesEnrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland