NCT04295863PHASE1Recruiting
Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
University of Chicago
Start Date
6/25/2020
Completion Date
4/12/2026
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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)
Interventions
DRUG
Nivolumab Standard
DRUG
Pembrolizumab Standard
DRUG
Nivolumab Extended
DRUG
Pembrolizumab Extended
Conditions
Metastatic Cancer
Locations
University Of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois 60637
United States
SSM Health Cancer Care
Madison, Wisconsin 53717
United States