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Timing of Immunotherapy in Melanoma
Sponsor: Radboud University Medical Center
Summary
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 from the randomized clinical trial will be combined with observational data.
Official title: Timing of Immunotherapy in Melanoma (TIME-NL): Dancing to the Beat of the Circadian Rhythm
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2026-08-01
Completion Date
2033-09-30
Last Updated
2026-07-22
Healthy Volunteers
No
Conditions
Interventions
Timing of first administration (early morning)
The timing of the first administration of combination immunotherapy starting before 10am
Timing of immunotherapy (afternoon)
The timing of the first administration of combination immunotherapy starting after 1pm
Locations (4)
Amsterdam UMC
Amsterdam, Netherlands
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Leiden UMC
Leiden, Netherlands
ErasmusMC
Rotterdam, Netherlands