Timing of Immunotherapy in Melanoma

Starting soon · Not applicable

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT07696715

Run by

Radboud University Medical Center

People needed

170

Starts

2026-08-01

Expected to finish

2033-09-30

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Amsterdam UMC — Amsterdam, Netherlands
• Antoni van Leeuwenhoek — Amsterdam, Netherlands
• Leiden UMC — Leiden, Netherlands
• ErasmusMC — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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