A Retrospective Observational Study on the Long-term Effects of Ipilimumab-treated Pediatric Participants in the Dutch Melanoma Treatment Registry (DMTR)

Active, not recruiting

• Conditions: Melanoma
• Interventions: Drug: Ipilimumab

• Registration Number: NCT04196452
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This is an observational, national, retrospective study consisting of pediatric patients with advanced (spread or unremoveable) melanoma identified in the DMTR in the Netherlands

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-18
• Status Verified: 2019-12
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-11
• Last Update Submitted: 2019-12-11
• Study First Posted: 2019-12-12
• Last Update Posted: 2019-12-12
• Primary Completion: 2029-03-31
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Less than 18 years of age at first dose of monotherapy Ipilimumab used for treatment of advanced melanoma
• Histological or cytological confirmation of advanced (unresectable or metastatic) melanoma

Exclusion Criteria

-Participation in a clinical trial within the past 4 weeks prior to first dose with ipilimumab or concurrently

Other inclusion/exclusion criteria apply

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm B: participants under 12	Ipilimumab	-
Arm A: participants 12 to under 18	Ipilimumab	-

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events (AEs) Grades 3-4	up to 10 years

Secondary Outcome Measures

Name	Time	Method
Assessment of Ipilimumab dose frequency	up to 10 years
Assessment of ipilimumab number of infusions	up to 10 years
Baseline assessment of population demographics	up to 10 years
Baseline assessment of disease characteristics	up to 10 years
Overall Survival (OS)	up to 10 years
Assessment of physical growth and development	up to 10 years
Assessment of changes in ipilumamb treatment: dose interruptions/discontinuations	up to 10 years
Baseline assessment of comorbidities	up to 10 years
Assessment of ipilimumab dose exposure	up to 10 years
Assessment of ipilimumab treatment duration	up to 10 years
Time to progression (TTP)	up to 10 years
Baseline assessment of treatment history	up to 10 years

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Princeton, New Jersey, United States