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

December 11, 2019 updated by: Bristol-Myers Squibb

Long-term Follow-up of Ipilimumab-treated Pediatric Patients Enrolled 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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm A: participants 12 to under 18
Drug: Ipilimumab
Specified dose on specified days
Arm B: participants under 12
Drug: Ipilimumab
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2019

Primary Completion (Anticipated)

March 31, 2029

Study Completion (Anticipated)

June 30, 2029

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

December 11, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-557

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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