Long-term follow-up of pediatric patients exposed to nivolumab + relatlimab fixed-dose combination (FDC) enrolled in the Dutch Melanoma Treatment Registry (DMTR) (CA224-122)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107907
• EU PAS number:
  EUPAS107906
• Study ID:
  107907
• Official title and acronym:
  Long-term follow-up of pediatric patients exposed to nivolumab + relatlimab fixed-dose combination (FDC) enrolled in the Dutch Melanoma Treatment Registry (DMTR) (CA224-122)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This post-authorization safety study (PASS) will collect long-term follow-up data in pediatric patients exposed to nivolumab + relatlimab fixed-dose combination, and is part of EMA approved European Union (EU) Risk Management Plan. Data will be collected through the Dutch Melanoma Treatment Registry
• Study status:
  Planned

Research institutions and networks

Institutions

Bristol-Myers Squibb (BMS)

Networks

Dutch Melanoma Treatment Registry (DMTR)

Study timelines

Date when funding contract was signed

Planned: 29/02/2024

Study start date

Planned: 30/06/2025

Data analysis start date

Planned: 30/06/2025

Date of interim report, if expected

Planned: 31/12/2026

Date of final study report

Planned: 31/12/2038

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)