NCT07574047Recrutement en cours
MELCHRONO: A Prospective Randomized Study Investigating Chrono-immunotherapy for Advanced Melanoma.
Résumé
Melanoma remains a common cancer with rising incidence, and despite significant improvements with immune checkpoint inhibitors (ICIs), clinical outcomes remain heterogeneous. Retrospective analyses across multiple tumor types, including melanoma, suggest that earlier daytime administration of ICIs may enhance therapeutic effectiveness, potentially due to circadian modulation of immune function. A pronounced survival benefit has been observed particularly among female patients receiving earlier infusions. This trial prospectively evaluates whether aligning ICI administration with circadian immune activity can improve outcomes in melanoma and support the development of sex-specific optimization of immunotherapy.
Critères d'inclusion
• 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.
Critères d'exclusion
• 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.
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 2
- Type d'étude
- Interventionnelle
- Pays
- Suisse
- Promoteur
- Swiss Cancer Institute(Autre)
- N° de protocole
- SCI-004_MELCHRONO
- Pathologies
- Melanoma, Advanced Melanoma
- Interventions
- Médicament
Traitements évalués
- Immune Checkpoint Inhibitors
- Immune Checkpoint Inhibitors
Lieux · 9
- Fribourg, SuisseHFR FribourgRecrute dans ce centre
- Basel, SuisseUniversitätsspital BaselRecrute dans ce centre
- Bellinzona, SuisseEnte Ospedaliero Cantonale (EOC)Recrute dans ce centre
- Bern, SuisseInselspital, BernRecrute dans ce centre
- Geneva, SuisseHôpitaux Universitaires de Genève HUGRecrute dans ce centre
- Lausanne, SuisseCentre Hospitalier Universitaire Vaudois (CHUV)Recrute dans ce centre
- Münsterlingen, SuisseSpital Thurgau (Kantonsspital Münserlingen und Frauenfeld)Recrute dans ce centre
- Sankt Gallen, SuisseHOCH Health Ostschweiz - Kantonsspital St. GallenRecrute dans ce centre
- Zurich, SuisseUniversitätsspital Zürich USZRecrute dans ce centre
Au total, dans le monde, les 9 centres listés au registre recrutent.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 27 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.