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

  • Interventional
  • Recruiting
  • NCT04295863
Eligibility Details Visit

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

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.


Age Group
18 Years and up

Accepting Healthy Volunteers?

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)

At a Glance

National Government IDNCT04295863


Lead SponsorUniversity of Chicago

Lead PhysicianMark J. Ratain


18 Years and up