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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) logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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