- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04196452
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
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
-
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New Jersey
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Princeton, New Jersey, United States, 08540
- Local Institution
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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
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Specified dose on specified days
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Arm B: participants under 12
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Specified dose on specified days
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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
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
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Ipilimumab
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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