Morning or Afternoon Timing of Immunotherapy for Metastatic Melanoma
Compares morning versus afternoon start of immunotherapy in adults with metastatic melanoma.
Plain-language title generated from the registry record
Registry title: Timing of Immunotherapy in Melanoma
Key facts
- Where
- Amsterdam, Leiden, Nijmegen, and Rotterdam, NetherlandsSee the 5 sites
Where in Netherlands
- Amsterdam UMCAmsterdam, NetherlandsNot yet recruiting
- Antoni van LeeuwenhoekAmsterdam, NetherlandsNot yet recruiting
- Leiden UMCLeiden, NetherlandsNot yet recruiting
- RadboudumcNijmegen, NetherlandsTaking people
- ErasmusMCRotterdam, NetherlandsNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Radboud University Medical Center
- Trial code
- NCT07696715
- Record updated
- 13 August 2026
- Original description
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.Read full original descriptionShow less
Timing of Immunotherapy in Melanoma (TIME-NL): Dancing to the Beat of the Circadian Rhythm
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.
Inclusion: 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: 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; Uveal or mucosal melanoma (unknown primary melanoma is allowed); Use of melatonin agonists.