Timing of Immunotherapy in Melanoma

Recruiting · NCT07696715 · Interventional (participants receive a specific treatment) · Lead sponsor: Radboud University Medical Center

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Melanoma

Interventions studied

Timing of first administration (early morning)Timing of immunotherapy (afternoon)

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

5 locations listed.

Amsterdam UMC - Amsterdam, Netherlands
Antoni van Leeuwenhoek - Amsterdam, Netherlands
Leiden UMC - Leiden, Netherlands
Radboudumc - Nijmegen, Netherlands
ErasmusMC - Rotterdam, Netherlands

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →