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Comparing Dosing Schedules for Nivolumab and Pembrolizumab in Advanced Cancers

This study is looking at nivolumab and pembrolizumab, two medications used for locally advanced or metastatic (spread to other parts of the body) cancers. Researchers want to see if these drugs can be given less often than their current approved schedules while still being effective. You might be eligible if you are 18 or older, have locally advanced or metastatic cancer, and your doctor thinks nivolumab or pembrolizumab is a good treatment option for you. The study will compare drug levels in your blood from standard dosing versus less frequent dosing. The main goal is to see if the less frequent dosing is just as good as the standard dosing over two years. This study aims to enroll 264 participants.

Study design
This is a randomized research study comparing different dosing schedules of nivolumab and pembrolizumab. It plans to enroll 264 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study will be measured at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04295863

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Chicago
~264 participants
Updated 2025-10-01 on ClinicalTrials.gov
What's tested:Nivolumab StandardPembrolizumab StandardNivolumab ExtendedPembrolizumab Extended

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Noninferiority margin of extended interval dosing compared to standard dosing
Measured over 2 years

Conditions

Metastatic Cancer

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Solid Neoplasm

NCT04295863

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • SSM Health Cancer Care

    Madison, Wisconsinstudy coordinator listed

    Recruiting

  • University Of Chicago Medicine Comprehensive Cancer Center

    Chicago, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mark Ratain, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Personalized Cancer Care Consortium
[email protected]
773.702.1220
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Noninferiority margin of extended interval dosing compared to standard dosing2 years

    To assess the noninferiority of pharmacokinetic success, defined as drug trough levels above the target concentration of 1.5 µg/mL. Evaluable patients will be categorized as success or failure for this primary objective.