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Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic 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
Who can join
Ages 18 and older · All sexes
Full eligibility 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)
About the study
A randomized research study of drugs nivolumab and pembrolizumab in patients with locally advanced or metastatic cancers. Based on data from earlier studies it appears that the drugs can be given less often then the currently approved schedule. This trial will compare drug levels from the blood from standard interval dosing levels versus taking the drugs less often.
What is being tested
- Nivolumab Standard (drug)
- Pembrolizumab Standard (drug)
- Nivolumab Extended (drug)
- Pembrolizumab Extended (drug)
Sponsor: University of Chicago · Participants: 264 · Started: Jun 25, 2020
Contact the study team
- Personalized Cancer Care Consortium · Phone: 773.702.1220
Official record on ClinicalTrials.gov — NCT04295863
Locations in the U.S.
| Illinois | University Of Chicago Medicine Comprehensive Cancer Center, Chicago |
| Wisconsin | SSM Health Cancer Care, Madison |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.