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

NCT04196452 | Active Not Recruiting

• 1 other identifier: CA184-557
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Frequency of Adverse Events (AEs) Grades 3-4

  up to 10 years

Secondary Outcomes (12)

• Baseline assessment of population demographics

  up to 10 years

• 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

Study Arms (2)

Arm A: participants 12 to under 18

Drug: Ipilimumab

Arm B: participants under 12

Drug: Ipilimumab

Interventions

Ipilimumab DRUG

Specified dose on specified days

Arm A: participants 12 to under 18; Arm B: participants under 12

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes participants who are under 18 years old who are diagnosed with advanced (unresectable or metastatic) melanoma who have been treated with ipilimumab and enrolled in the DMTR

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 12, 2019
• Study Start: August 12, 2019
• Primary Completion (Estimated): February 20, 2034
• Study Completion (Estimated): July 24, 2034
• Last Updated: November 20, 2025

Record last verified: 2025-11