Actively Recruiting
Impact of Circadian Rhythm on Immunotherapy
Led by Liza Villaruz, MD · Updated on 2025-12-09
350
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Impact of Circadian Rhythm on Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Advanced/metastatic NSCLC patients eligible for first-line PD-1/PD-L1 therapy alone or in combination (Cohort A)
- Advanced/metastatic NSCLC patients who completed up to 4 cycles of induction therapy with stable or responsive disease eligible for maintenance anti-PD-1/PD-L1 therapy (Cohort B)
- Advanced/metastatic solid tumor patients eligible for first-line anti-PD-1/PD-L1 therapy alone or in combination (Cohort C)
- Patients must be immunotherapy-na�ve for Cohorts A and C, or eligible for maintenance therapy after induction for Cohort B
- Willing to be randomized to treatment time of day (early morning or later in the day)
- Eligible to receive anti-PD-1/PD-L1 therapy according to approved labels and investigator judgment
- Able to understand and sign informed consent
- Able to read and write in English
You will not qualify if you...
- Unable to receive anti-PD-1/PD-L1 therapy due to prior allergic reactions to the therapy or any of its ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
J
Jennifer Ruth, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here