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Clinical Trials in the Netherlands / NCT07696715
Recruiting Not applicable

Timing of Immunotherapy in Melanoma

NCT07696715 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Radboud University Medical Center
Phase
Not applicable
Started
2026-08-10
Last updated
2026-08-13

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

Timing of first administration (early morning)Timing of immunotherapy (afternoon)

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion 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. * Starting treatment with standard-of-care combination immunotherapy (ipilimumab+nivolumab) as first line treatment. * Signed informed consent form Exclusion Criteria: * 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. * Prior systemic therapy for irresectable/metastatic melanoma (prior T-VEC is allowed) * Prior systemic therapy for resectable melanoma in the last 6 months (neo-adjuvant and adjuvant treatment is allowed if at least 6 months ago). * Use of investigational drugs.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Amsterdam UMC Amsterdam Netherlands Not Yet Recruiting
Antoni van Leeuwenhoek Amsterdam Netherlands Not Yet Recruiting
Leiden UMC Leiden Netherlands Not Yet Recruiting
Radboudumc Nijmegen Netherlands Recruiting
ErasmusMC Rotterdam Netherlands Not Yet Recruiting

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Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07696715 on ClinicalTrials.gov ↗ ← All trials in the Netherlands