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Impact of Circadian Rhythm on Immunotherapy
Sponsor: Liza Villaruz, MD
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).
Official title: Assessing the Impact of Circadian Rhythm on Anti-PD-1/PD-L1 Immunotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2025-12-02
Completion Date
2030-05-01
Last Updated
2025-12-09
Healthy Volunteers
No
Conditions
Interventions
Immunotherapy - PD-1 Blocker
Standard of Care Drugs (at investigator's discretion) may include: pembrolizumab, nivolumab, cemiplimab, durvalumab, dostarlimab, avelumab, and atezolizumab, or other immune checkpoint inhibitors used in cancer treatment that targets cancer cells by blocking the PD-1 receptor on T cells.
Locations (1)
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States