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

• Status: Recruiting
• Trial end date: 2025-04-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Nivolumab; Pembrolizumab

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)