Clinical trial · Interventional
Timing of Immunotherapy in Melanoma
Timing of Immunotherapy in Melanoma (TIME-NL): Dancing to the Beat of the Circadian Rhythm
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Timing of first administration (early morning) | Other | — | UNRESOLVED |
| Timing of immunotherapy (afternoon) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: early morning immunotherapy
- description
- Standard-of-care immune checkpoint inhibition with ipilimumab + nivolumab with the first administration starting before 10am
- interventionNames
- Other: Timing of first administration (early morning)
- type
- ACTIVE_COMPARATOR
- label
- B: afternoon immunotherapy
- description
- Standard-of-care immune checkpoint inhibition with ipilimumab + nivolumab with the first administration starting after 1pm
- interventionNames
- Other: Timing of immunotherapy (afternoon)
Primary outcomes (1)
- measure
- Best overall response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available