MELCHRONO: Chrono-immunotherapy timing for advanced 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

This phase 2 trial investigates chrono-immunotherapy by timing immune checkpoint inhibitors to circadian immune rhythms in adults with unresectable stage III/IV melanoma. It includes sex-stratified analyses to see if timing benefits differ between men and women. Participants receive standard ICIs with a predefined dosing schedule guided by circadian biology, aiming to improve response while monitoring safety. The study accommodates prior cancers and CNS metastases, with eligibility based on performance status and treatment suitability. Conducted at multiple Swiss centers, it seeks to personalize immunotherapy by considering biological time and sex as factors in treatment planning.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent according to Swiss law and ICH GCP E6 regulations before registration and prior to any trial specific procedures.
* Histologically confirmed unresectable cutaneous stage III or stage IV melanoma. Note: Participants with central nervous system (CNS) metastases are eligible.
* Participants with a previously treated other malignancy are eligible, if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low.
* Measurable or evaluable disease.
* Age ≥ 18 years.
* Patients deemed suitable for ICI therapy based on the local investigator's clinical assessment.
* ECOG performance status 0-2.
* Women of childbearing potential must use effective contraception , not be pregnant or lactating and agree not to become pregnant during trial treatment and until 5 months after the last dose of trial treatment. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential.
* Men agree not to donate sperm or to father a child during trial treatment and until 5 months after the last dose of trial treatment.

Exclusion Criteria:

* Prior treatment with any systemic anti-cancer therapy; with the exception of prior adjuvant anti-PD-1 or BRAF/MEK inhibitor therapy if the time from last dose to recurrence is more than 6 months.
* Recent treatment (within 28 days prior to first dose) with any experimental drug.
* Known history of allogeneic organ transplant.
* Uveal or mucosal melanoma.
* Receipt of live attenuated vaccine within 28 days prior to first dose.
* Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information.
* Known hypersensitivity to trial drug(s) or to any component of the trial drug(s).
* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect participant compliance or place the participant at high risk from treatment-related complications.

Where it's running

• HFR Fribourg
  Fribourg, Canton of Fribourg, Switzerland Recruiting
• Universitätsspital Basel
  Basel, Switzerland Recruiting
• Ente Ospedaliero Cantonale (EOC)
  Bellinzona, Switzerland Recruiting
• Inselspital, Bern
  Bern, Switzerland Recruiting
• Hôpitaux Universitaires de Genève HUG
  Geneva, Switzerland Recruiting
• Centre Hospitalier Universitaire Vaudois (CHUV)
  Lausanne, Switzerland Recruiting

Study contacts

• Study coordinator: Lenka Vokalova, PhD
• Email: trials@swisscancerinstitute.ch
• Phone: +41 31 389 91 91

Similar studies

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

• Neoadjuvant and adjuvant immunotherapy for advanced melanoma

  This study is testing if a new type of immunotherapy can help people with advanced melanoma do better before and after surgery.

  Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT06295159

• Melanoma treatment with immunotherapy guided by serial ctDNA testing

  This trial tests whether regular ctDNA blood tests during treatment can help tailor the plan for patients with advanced melanoma receiving nivolumab and ipilimumab.

  Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07930182

• Non-invasive skin-tape test to detect melanoma using methylation biomarkers

  A non-invasive skin-tape test is being tried to see if it can detect melanoma in people who are about to have a biopsy for a suspicious pigmented lesion.

  Recruiting at 4 sites Mitra Bio · Ghent and 4 other locations · NCT07883954

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• BL-M08D treatment in melanoma and other solid tumors

  A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07841925

• Aggressive lipid lowering in melanoma patients starting immune checkpoint therapy

  This trial tests whether lowering cholesterol aggressively can reduce heart artery disease risk in melanoma patients who are just beginning immune checkpoint therapy.

  Recruiting University of Colorado, Denver · Aurora, Colorado · NCT07704918

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.