Timing of Immunotherapy in Melanoma

The TIME-NL trial is a multicenter, randomized, open-label clinical trial in the Netherlands to assess the effect of the timing of the first administration of standard-of-care intravenous combination immunotherapy (early morning versus afternoon) in patients with metastatic melanoma. Patients will be randomized 1:1 to start standard-of-care ICI administration either before 10am (early morning arm; arm A) or after 1pm (afternoon arm; arm B). Patients will be stratified according to performance status and study center. The randomized clinical trial will be part of a hybrid design in which data f

Trial Details

NCT ID
NCT07696715
Phase
NA
Sponsor
Radboud University Medical Center
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Timing of first administration (early morning)
  • Timing of immunotherapy (afternoon)
Locations (sample)
  • Amsterdam, Netherlands|52.37403,4.88969
  • Amsterdam, Netherlands|52.37403,4.88969
  • Leiden, Netherlands|52.15833,4.49306
  • Nijmegen, Netherlands|51.8425,5.85278
  • Rotterdam, Netherlands|51.9225,4.47917

Key Eligibility Criteria

  • Histologically or cytologically confirmed cutaneous melanoma, classified as irresectable (stage III) or metastatic (stage IV) disease.
  • At least 18 years of age.
  • World Health Organization (WHO) Performance Status 0-1.
  • Measurable disease according to RECIST 1.1.

For full eligibility, visit ClinicalTrials.gov.

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