NCT06163170

A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma

Real-World Evaluation of Patient Characteristics, Treatment Patterns, Safety, and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab for Pediatric Melanoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 metastatic melanoma, or treated with adjuvant nivolumab after resection of stage IIB-IV melanoma. Demographic and clinical characteristics, and treatment patterns, will also be described in this population.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab +/- ipilimumab	Participants treated with nivolumab +/- ipilimumab for unresectable/metastatic melanoma
DRUG	Nivolumab	Participants treated with nivolumab as adjuvant therapy for resected stage IIB-IV melanoma

Timeline

• Start date: 2023-08-14
• Primary completion: 2023-09-25
• Completion: 2023-11-10
• First posted: 2023-12-08
• Last updated: 2024-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study