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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04196452
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Anticipated Duration (Months): 120.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: Ipilimumab

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Long-term Follow-up of Ipilimumab-treated Pediatric Patients Enrolled in the Dutch Melanoma Treatment Registry (DMTR)
• Actual Study Start Date: Jun 18, 2019
• Anticipated Primary Completion Date: Mar 31, 2029
• Anticipated Study Completion Date: Jun 30, 2029

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Frequency of Adverse Events (AEs) Grades 3-4 [up to 10 years]

Secondary Outcome Measures

1. Baseline assessment of population demographics [up to 10 years]

2. Baseline assessment of comorbidities [up to 10 years]

3. Baseline assessment of disease characteristics [up to 10 years]

4. Baseline assessment of treatment history [up to 10 years]

5. Assessment of ipilimumab dose exposure [up to 10 years]

6. Assessment of changes in ipilumamb treatment: dose interruptions/discontinuations [up to 10 years]

7. Assessment of Ipilimumab dose frequency [up to 10 years]

8. Assessment of ipilimumab treatment duration [up to 10 years]

9. Assessment of ipilimumab number of infusions [up to 10 years]

10. Overall Survival (OS) [up to 10 years]

11. Time to progression (TTP) [up to 10 years]

12. Assessment of physical growth and development [up to 10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04196452
• Other Study ID Numbers: CA184-557
• First Posted: Dec 12, 2019
• Last Update Posted: Dec 12, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Melanoma; Ipilimumab

Study Results

No Results Posted as of Dec 12, 2019