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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
The timing of the first administration of combination immunotherapy starting before 10am
The timing of the first administration of combination immunotherapy starting after 1pm
Amsterdam UMC
Amsterdam, Netherlands
NOT_YET_RECRUITINGAntoni van Leeuwenhoek
Amsterdam, Netherlands
NOT_YET_RECRUITINGLeiden UMC
Leiden, Netherlands
NOT_YET_RECRUITINGRadboudumc
Nijmegen, Netherlands
RECRUITINGErasmusMC
Rotterdam, Netherlands
NOT_YET_RECRUITINGBest overall response rate
Best overall response rate (radiological complete or partial response according to RECIST 1.1)
Time frame: from enrollment to 1year
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