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

The University of Chicago

Status and phase

Enrolling

Phase 1

Conditions

Metastatic Cancer

Treatments

Drug: Nivolumab Extended

Drug: Pembrolizumab Standard

Drug: Nivolumab Standard

Drug: Pembrolizumab Extended

Study type

Interventional

Funder types

Other

Identifiers

NCT04295863

IRB19-1718

Details and patient eligibility

About

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.

Enrollment

264 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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)