Comparing how often to give nivolumab or pembrolizumab for advanced cancers
Official title: A Randomized Study Investigating the Pharmacokinetics of Standard Interval Dosing Compared to Extended Interval Dosing of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
Run by University of Chicago · NCT04295863 · Data updated 2026-11-12
This study is testing if giving nivolumab or pembrolizumab less often can still help people with advanced cancers just as well as the usual schedule.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 264 (estimated) |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | nivolumab, pembrolizumab, ipilimumab, axitinib, chemotherapy |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Status | Recruiting |
| Started | June 25, 2020 |
| Main results expected | April 12, 2026 |
| Study ends | April 12, 2026 |
| Registry record updated | October 1, 2025 |
| Trial ID | NCT04295863 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with locally advanced or metastatic cancer who are eligible for treatment with nivolumab or pembrolizumab.
✕Probably not a fit
Patients who have previously received immune checkpoint inhibitors or are planned to receive certain combinations of therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a randomized study that evaluates the effectiveness of nivolumab and pembrolizumab in patients with locally advanced or metastatic cancers. It aims to determine if these drugs can be administered less frequently than the currently approved dosing schedule, based on previous studies suggesting this may be possible. Participants will be assigned to receive either standard or extended dosing intervals, and blood samples will be analyzed to compare drug levels. The goal is to optimize treatment regimens for better patient outcomes.
Why it matters
Potential benefit: If successful, this study could lead to more effective and convenient treatment schedules for patients with advanced cancers.
How similar studies have gone: Other studies have shown promise in optimizing dosing schedules for immunotherapies, suggesting this approach may yield beneficial results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with locally advandced or metastatic cancer whose physician has determined they are candidates for treatment with nivolumab or pembrolizumab * 18 years old or older * Measurable disease per RECIST criteria Exclusion Criteria: * Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy. * Patients whose treatment plan is to receive ipilimumab or other anti-CTLA4 monoclonal antibody in combination with either nivolumab or pembrolizumab. * Ipilimumab and nivolumab combination are not eligible for this trial. * (Note: Patients whose planned treatment is the combination of anti-PD-1 and tyrosine kinase inhibitor such as pembrolizumab-axitinib or the combination of traditional cytotoxic chemotherapy and anti-PD-1 are eligible)
Where it's running
-
University Of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States Recruiting -
SSM Health Cancer Care
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Mark Ratain, MD — University of Chicago
- Study coordinator: Personalized Cancer Care Consortium
- Email: PhaseIICRA@medicine.bsd.uchicago.edu
- Phone: 773.702.1220
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.