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 from the randomized clinical trial will be combined with observational data.

NCT Number	NCT07696715
Lead Sponsor	Radboud University Medical Center
Conditions	Melanoma
Enrollment	170 participants
Start Date	2026-08-10
Primary Completion	2029-09-30 (estimated)
Study Completion	2033-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-13