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

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Melanoma

Treatments: Drug: Ipilimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04196452

CA184-557

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

10 participants in 2 patient groups

Arm A: participants 12 to under 18

Treatment:

Drug: Ipilimumab

Arm B: participants under 12

Treatment:

Drug: Ipilimumab