Comparing how often to give nivolumab or pembrolizumab for advanced cancers
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
PHASE1 · University of Chicago · NCT04295863
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 | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago (other) |
| Drugs / interventions | nivolumab, pembrolizumab, ipilimumab, axitinib, chemotherapy |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT04295863 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in optimizing dosing schedules for immunotherapies, suggesting this approach may yield beneficial results.
Eligibility criteria
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 this trial is running
Chicago, Illinois and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Cancer