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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

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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