Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers

Recruiting now · Phase 1

Conditions studied: Metastatic Cancer

In brief

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.

Key facts

Study ID

NCT04295863

Run by

University of Chicago

People needed

264

Starts

2020-06-25

Expected to finish

2026-04-12

Last updated by the study team

2025-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• University Of Chicago Medicine Comprehensive Cancer Center — Chicago, Illinois, United States (enrolling)
• SSM Health Cancer Care — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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