MelanomaNCT04196452
A Retrospective Observational Study on the Long-term Effects of Ipilimumab-treated Pediatric Participants in the Dutch Melanoma Treatment Registry (DMTR)
An observational study of Melanoma, run by Bristol-Myers Squibb.
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 Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Ipilimumab
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2019to 24 Jul 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- -Participation in a clinical trial within the past 4 weeks prior to first dose with ipilimumab or concurrently
- Other inclusion/exclusion criteria apply
About this study
Official title: 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
- Conditions
- Melanoma
- Being tested
- Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: participants 12 to under 18 | Not described Receives: Drug: Ipilimumab | |
| Arm B: participants under 12 | Not described Receives: Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events (AEs) Grades 3-4
Measured: up to 10 years
Secondary outcomes (12)
Baseline assessment of population demographics
Measured: up to 10 years
Baseline assessment of comorbidities
Measured: up to 10 years
Baseline assessment of disease characteristics
Measured: up to 10 years
Baseline assessment of treatment history
Measured: up to 10 years
Assessment of ipilimumab dose exposure
Measured: up to 10 years
Assessment of changes in ipilumamb treatment: dose interruptions/discontinuations
Measured: up to 10 years
Assessment of Ipilimumab dose frequency
Measured: up to 10 years
Assessment of ipilimumab treatment duration
Measured: up to 10 years
Assessment of ipilimumab number of infusions
Measured: up to 10 years
Overall Survival (OS)
Measured: up to 10 years
Time to progression (TTP)
Measured: up to 10 years
Assessment of physical growth and development
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start12 Aug 2019
- Primary completion20 Feb 2034 (estimated)
- Study completion24 Jul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196452
- Sponsor's protocol ID
- CA184-557
- Status last verified
- Nov 2025
- First submitted
- 11 Dec 2019
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Ipilimumab-treated Pediatric Patients Enrolled in the Dutch Melanoma Treatment Registry (DMTR)
- ClinicalTrials.gov ID
- NCT04196452
- Acronym / sponsor ID
- CA184-557
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 20 Feb 2034 (estimated)
- Study completion
- 24 Jul 2034 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: participants 12 to under 18 | – | Drug: Ipilimumab |
| Arm B: participants under 12 | – | Drug: Ipilimumab |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- -Participation in a clinical trial within the past 4 weeks prior to first dose with ipilimumab or concurrently
- Other inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IpilimumabSpecified dose on specified days | Drug | Arm A: participants 12 to under 18, Arm B: participants under 12 |
Primary outcome
Frequency of Adverse Events (AEs) Grades 3-4
Time frame: up to 10 years
12 secondary outcomes
Baseline assessment of population demographics
Time frame: up to 10 years
Baseline assessment of comorbidities
Time frame: up to 10 years
Baseline assessment of disease characteristics
Time frame: up to 10 years
Baseline assessment of treatment history
Time frame: up to 10 years
Assessment of ipilimumab dose exposure
Time frame: up to 10 years
Assessment of changes in ipilumamb treatment: dose interruptions/discontinuations
Time frame: up to 10 years
Assessment of Ipilimumab dose frequency
Time frame: up to 10 years
Assessment of ipilimumab treatment duration
Time frame: up to 10 years
Assessment of ipilimumab number of infusions
Time frame: up to 10 years
Overall Survival (OS)
Time frame: up to 10 years
Time to progression (TTP)
Time frame: up to 10 years
Assessment of physical growth and development
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Bristol-Myers Squibb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (AEs) Grades 3-4 (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.