Timing of Immunotherapy in Melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The TIME-NL trial is a multicenter, randomized study in the Netherlands that compares the first-dose timing of a standard-of-care ipilimumab plus nivolumab combination. Participants are randomized 1:1 to start treatment either in the early morning or in the afternoon, with stratification by performance status and site. The design includes a hybrid approach, combining randomized data with observational data to explore outcomes. Eligible patients have unresectable stage III or stage IV cutaneous melanoma, are 18 years or older, and have measurable disease. Exclusions include uveal or mucosal melanoma and prior systemic therapy for advanced disease, among others.

Why it matters

Who can join: the full rules

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's running

• Radboudumc
  Nijmegen, Netherlands Recruiting
• Amsterdam UMC
  Amsterdam, Netherlands Not yet recruiting
• Antoni van Leeuwenhoek
  Amsterdam, Netherlands Not yet recruiting
• Leiden UMC
  Leiden, Netherlands Not yet recruiting
• ErasmusMC
  Rotterdam, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Kalijn Bol, MD/PhD
• Email: kalijn.bol@radboudumc.nl
• Phone: +31243618800

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.