drugset / Trial / NCT07224971

Impact of Circadian Rhythm on Immunotherapy

NCT07224971

Phase 2 Recruiting 350 enrolled Liza Villaruz, MD
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to determine whether morning versus afternoon treatment impacts efficacy of (standard of care) immunotherapy in a broad patient population. Patients with any type of advanced/metastatic malignancy are eligible to enroll in this study, as long as first-line anti-PD-1/PD-L1 immunotherapy is on label for their condition. Participants will then be randomized to either the early treatment group (administration must start and conclude by 11:00 AM +1 hour window) or the late treatment group (administration must start after 12:00 PM).

Timeline

Start
2025-12-02
Primary completion
2027-05-01
Completion
2030-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody
Subject Avelumab Monoclonal antibody
Subject Cemiplimab Monoclonal antibody
Subject Dostarlimab Monoclonal antibody
Subject Durvalumab Monoclonal antibody
Subject Nivolumab Monoclonal antibody
Subject Pembrolizumab Monoclonal antibody