What this study is
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).
What's being tested
- Immunotherapy - PD-1 Blocker
Intervention · DRUG
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.
Study details
- Official title
- Assessing the Impact of Circadian Rhythm on Anti-PD-1/PD-L1 Immunotherapy
- Sponsor
- Liza Villaruz, MD
- Conditions
- Advanced/Metastatic NSCLC
- Enrolling
- 350 people
- Starts
- 2025-12-02
- Est. completion
- 2030-05-01
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Cohort Specific Criteria; Cohort A: Advanced/metastatic NSCLC patients for which 1st line PD-1/PD-L1 therapy is on-label either alone or in combination.; Cohort B: Advanced/metastatic NSCLC patients who have completed up to 4 cycles of induction therapy who have stable disease or responsive disease and for which maintenance anti-PD-1/PD-L1 therapy is on-label either alone or in combination.; Cohort C: Advanced/metastatic solid tumor malignancy for which first-line anti-PD-1/PD-L1 therapy is on-label either alone or in combination.
- Prior and concurrent therapy criteria o Patients should be ICI-naïve (this should be first-line therapy) (Cohorts A and C), or should have received ICI induction therapy and are now eligible for ICI maintenance therapy (Cohort B).
- Must be willing to be randomized to complete therapy at assigned time of day, which may be early in the morning OR later in the day/into the evening.
- Must be eligible to receive anti-PD-1/PD-L1 therapy singly or in combination with other FDA-approved agents according to standard of care practices, as determined by the clinical judgment of the investigator but according to approved label indications
- Must have the ability to understand and the willingness to sign a written informed consent document.
- Able to read and write in English.
You can't join if
- Participant unable to receive anti-PD-1/PD-L1 therapy due to prior allergic reactions to therapy or any therapy ingredients.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
- Jennifer Ruth, RN · Contact412-623-8963ruthj2@upmc.edu
- Liza Villaruz, MD · Principal investigator
Recruiting
Study team
Sponsor
Liza Villaruz, MD
Study ID HCC 25-127
Principal investigator
Liza Villaruz, MD
UPMC Hillman Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.