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

Long-term Follow-up of Ipilimumab-treated Pediatric Patients Enrolled in the Dutch Melanoma Treatment Registry (DMTR)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04196452

Enrollment

Registered

2019-12-12

Start date

2019-08-12

Completion date

2034-07-24

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

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

Interventions

DRUGIpilimumab

Specified dose on specified days

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

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/

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026