drugset / Trial / NCT07574047

MELCHRONO: A Prospective Randomized Study Investigating Chrono-immunotherapy for Advanced Melanoma.

NCT07574047

Phase 4 Not yet recruiting 108 enrolled Swiss Cancer Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-09
Primary completion
2030-06
Completion
2032-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Relatlimab Monoclonal antibody 160 mg Intravenous

Indications