Melanoma
Conditions
Keywords
melanoma, chronoimmunotherapy, timing
Brief 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.
Interventions
OTHERTiming of first administration (early morning)
The timing of the first administration of combination immunotherapy starting before 10am
OTHERTiming of immunotherapy (afternoon)
The timing of the first administration of combination immunotherapy starting after 1pm
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best overall response rate | from enrollment to 1year | Best overall response rate (radiological complete or partial response according to RECIST 1.1) |
Countries
Netherlands
Contacts
CONTACTKalijn Bol, MD/PhD
CONTACTMirte Meijerink
Outcome results
None listed