Recruiting
Phase 1

Nivolumab vs. Pembrolizumab

Sponsor:

University of Chicago

Code:

NCT04295863

Conditions

Metastatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nivolumab Standard

Pembrolizumab Standard

Nivolumab Extended

Pembrolizumab Extended

Study Details

Brief 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.

Conditions

Metastatic Cancer

Study ID

NCT04295863

Start date

Jun 25, 2020

Status verified date

Sep, 2025

Completion date

Apr 12, 2026

Anticipated

Primary completion date

Apr 12, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

264 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: standard interval dosing

experimental: extended interval dosing

Interventions

Nivolumab Standard

For patients on standard schedule dosing of nivolumab, therapy will consist of 240mg IV once every 2 weeks or 480mg IV once every 4 weeks

Pembrolizumab Standard

For patients on standard schedule dosing of pembrolizumab, therapy will consist of 200mg IV once every 3 weeks or 400mg IV once every 6 weeks

Nivolumab Extended

For patients on extended interval dosing of nivolumab therapy will consist of 240mg IV once every 4 weeks or 480mg IV once every 8 weeks

Pembrolizumab Extended

For patients on extended interval dosing of pembrolizumab therapy will consist of 200mg IV once every 6 weeks

Primary outcome measure

  • Noninferiority margin of extended interval dosing compared to standard dosing [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Personalized Cancer Care Consortium

773.702.1220PhaseIICRA@medicine.bsd.uchicago.edu

Locations

University Of Chicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Trials Intake

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Mark Ratain, MD

SSM Health Cancer Care

Recruiting

Madison, Wisconsin, United States, 53717

Contacts

Terri Roberts

608-410-2769terri.roberts@ssmhealth.com

Nicole Schultz

608-410-2774nicole.schultz1@ssmhealth.com

Principal Investigator:

Amit Sanyal, MD

More Information

Sponsor

University of Chicago

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-10-01.