NCT07696715Recruiting
Timing of Immunotherapy in Melanoma
Timing of Immunotherapy in Melanoma (TIME-NL): Dancing to the Beat of the Circadian Rhythm
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 6 Jul 2026
- Start date
- 10 Aug 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Melanoma
- NCT number
- NCT07696715
What you commit to
- Study type: Interventional
- Planned participants: 170
- From 10 Aug 2026 to the primary completion date, 30 Sept 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of systemic immunosuppressive medications. Inhaled or topical steroids are permitted.
- Use of adrenal replacement medications, e.g. hydrocortisone.
- 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.
Other
- Uveal or mucosal melanoma (unknown primary melanoma is allowed).
- Use of melatonin agonists.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Antoni van Leeuwenhoek Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Leiden UMC Coordinator of this site? Confirm its status | Leiden | Netherlands | Not yet recruiting |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| ErasmusMC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.