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NCT04196452 Clinical Trial

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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04196452
Other study ID # CA184-557
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 18, 2019
Est. completion date June 30, 2029

Study information
Verified date December 2019
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 10
Est. completion date June 30, 2029
Est. primary completion date March 31, 2029
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ipilimumab
Specified dose on specified days

Locations
Country Name City State
United States Local Institution Princeton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of Adverse Events (AEs) Grades 3-4 up to 10 years
Secondary Baseline assessment of population demographics up to 10 years
Secondary Baseline assessment of comorbidities up to 10 years
Secondary Baseline assessment of disease characteristics up to 10 years
Secondary Baseline assessment of treatment history up to 10 years
Secondary Assessment of ipilimumab dose exposure up to 10 years
Secondary Assessment of changes in ipilumamb treatment: dose interruptions/discontinuations up to 10 years
Secondary Assessment of Ipilimumab dose frequency up to 10 years
Secondary Assessment of ipilimumab treatment duration up to 10 years
Secondary Assessment of ipilimumab number of infusions up to 10 years
Secondary Overall Survival (OS) up to 10 years
Secondary Time to progression (TTP) up to 10 years
Secondary Assessment of physical growth and development up to 10 years
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