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

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.

NCT Number	NCT07574047
Lead Sponsor	Swiss Cancer Institute
Conditions	Melanoma, Advanced Melanoma
Enrollment	108 participants
Start Date	2026-09
Primary Completion	2030-06 (estimated)
Study Completion	2032-06 (estimated)
Updated on ClinicalTrials.gov	2026-07-31