RecruitingPhase 2NCT07224971

Impact of Circadian Rhythm on Immunotherapy

Assessing the Impact of Circadian Rhythm on Anti-PD-1/PD-L1 Immunotherapy


Sponsor

Liza Villaruz, MD

Enrollment

350 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether the time of day that cancer immunotherapy (checkpoint inhibitor drugs) is administered affects how well it works. Researchers believe the body's internal clock (circadian rhythm) may influence immune function and therefore the effectiveness of these drugs for lung cancer and other solid tumors. **You may be eligible if...** - You have advanced or metastatic non-small cell lung cancer (NSCLC) or another solid tumor for which a PD-1/PD-L1 immunotherapy is an approved first-line treatment - You have not yet received checkpoint immunotherapy (or are receiving it in an induction phase and transitioning to maintenance) - You are willing to be randomized to receive your infusion in the morning OR later in the day/evening - Your cancer treatment plan is to receive PD-1/PD-L1 immunotherapy alone or in combination with approved drugs **You may NOT be eligible if...** - You have already received checkpoint immunotherapy in a prior line of treatment - You have a scheduling conflict or medical issue that prevents you from receiving infusions at an assigned time of day - You are not eligible for PD-1/PD-L1 immunotherapy per your oncologist Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGImmunotherapy - 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07224971