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

N/AActive Not RecruitingNCT04196452

Bristol-Myers Squibb10 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Melanoma

Interventions

IpilimumabDRUG

Specified dose on specified days

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

For more information regarding Bristol-Myers Squibb Clinical Trials, please visit www.BMSStudyConnect.com. 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

Outcomes

Primary Outcomes

Frequency of Adverse Events (AEs) Grades 3-4

Time frame: up to 10 years

Secondary Outcomes

Baseline assessment of population demographics

Time frame: up to 10 years

Baseline assessment of comorbidities

Time frame: up to 10 years

Baseline assessment of disease characteristics

Time frame: up to 10 years

Baseline assessment of treatment history

Time frame: up to 10 years

Assessment of ipilimumab dose exposure

Time frame: up to 10 years

Assessment of changes in ipilumamb treatment: dose interruptions/discontinuations

Time frame: up to 10 years

Assessment of Ipilimumab dose frequency

Time frame: up to 10 years

Assessment of ipilimumab treatment duration

Time frame: up to 10 years

Assessment of ipilimumab number of infusions

Time frame: up to 10 years

Overall Survival (OS)

Time frame: up to 10 years

Time to progression (TTP)

Time frame: up to 10 years

Data from ClinicalTrials.gov

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