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NCT Number: NCT04196452

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipilimumab

Drug

Specified dose on specified days

Primary outcomes

  1. Frequency of Adverse Events (AEs) Grades 3-4

    Time frame: up to 10 years

Secondary outcomes

  1. Baseline assessment of population demographics

    Time frame: up to 10 years

  2. Baseline assessment of comorbidities

    Time frame: up to 10 years

  3. Baseline assessment of disease characteristics

    Time frame: up to 10 years

  4. Baseline assessment of treatment history

    Time frame: up to 10 years

  5. Assessment of ipilimumab dose exposure

    Time frame: up to 10 years

  6. Assessment of changes in ipilumamb treatment: dose interruptions/discontinuations

    Time frame: up to 10 years

  7. Assessment of Ipilimumab dose frequency

    Time frame: up to 10 years

  8. Assessment of ipilimumab treatment duration

    Time frame: up to 10 years

  9. Assessment of ipilimumab number of infusions

    Time frame: up to 10 years

  10. Overall Survival (OS)

    Time frame: up to 10 years

  11. Time to progression (TTP)

    Time frame: up to 10 years

  12. Assessment of physical growth and development

    Time frame: up to 10 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2034
Study completion
2034
First posted
Dec 12, 2019
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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