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 type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  OPDUALAG

Population studied

• Age groups:
  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  20

Study design details

• Main study objective:
  The main objective is to evaluate Grade 3 to 4 adverse drug reactions (including immune-related adverse reactions) experienced by pediatric patients treated with nivolumab + relatlimab FDC, and their management.
• Outcomes:
  Number of participants with Frequency of Grade 3 to 4 adverse drug reactions (ADRs) as assessed by the Common Terminology Criteria for Adverse Events (Version 6) criteria ADR management, Participant baseline demographic, comorbidities, disease characteristics, treatment history Dose levels and frequency of nivolumab+relatlimab (nivo+rela) FDC treatment Number of nivo+rela FDC treatment infusions Number of participants with nivo+rela FDC treatment dose interruptions or discontinuations, subsequent therapies, or growth/development disorders Overall survival Time to progression
• Data analysis plan:
  A detailed Statistical Analysis Plan will be developed for this study. General descriptive statistics will include mean, median, minimum, maximum, and standard deviation for continuous variables, count and percentages will be used to examine categorical variables. The time to event endpoint will be analyzed according to the Kaplan-Meier method, as data allow. Data from all patients who receive at least 1 dose of treatment will be analyzed. The treated set is defined as all patients enrolled in the registry and meeting the study eligibility criteria and receiving at least 1 dose of treatment. The data collected at baseline will be used to characterize the population. Descriptive statistics will be provided to assess demographic information, disease characteristics and other clinical characteristics, and treatment history.