Timing of Immunotherapy in Melanoma
ConditionMelanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Uveal or mucosal melanoma (unknown primary melanoma is allowed).
Use of systemic immunosuppressive medications. Inhaled or topical steroids are permitted.
Use of adrenal replacement medications, e.g. hydrocortisone.
Use of melatonin agonists.
Trial design
Design model
Parallel
Treatments tested in this trial
Timing of first administration (early morning)
Other interventionThe timing of the first administration of combination immunotherapy starting before 10am
Timing of immunotherapy (afternoon)
Other interventionThe timing of the first administration of combination immunotherapy starting after 1pm
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: A: early morning immunotherapyActive comparator 1 intervention
Group B: B: afternoon immunotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Best overall response rate
Best overall response rate (radiological complete or partial response according to RECIST 1.1)
Time frame
from enrollment to 1yearSponsors and contacts
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Source ClinicalTrials.gov