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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer
• Intervention / Treatment: Drug: Nivolumab Standard; Drug: Pembrolizumab Standard; Drug: Nivolumab Extended; Drug: Pembrolizumab Extended

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Personalized Cancer Care Consortium; Phone Number: 773.702.1220; Email: PhaseIICRA@medicine.bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medicine Comprehensive Cancer Center
      • Principal Investigator: Mark Ratain, MD
      • Contact: Clinical Trials Intake; Phone Number: 855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu
  • Wisconsin
    • Madison, Wisconsin, United States, 53717
      • Recruiting
      • SSM Health Cancer Care
      • Contact: Terri Roberts; Phone Number: 608-410-2769; Email: terri.roberts@ssmhealth.com
      • Contact: Nicole Schultz; Phone Number: 608-410-2774; Email: nicole.schultz1@ssmhealth.com
      • Principal Investigator: Amit Sanyal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard interval dosing	Drug: 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; Drug: 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
Experimental: extended interval dosing	Drug: 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; Drug: Pembrolizumab Extended; For patients on extended interval dosing of pembrolizumab therapy will consist of 200mg IV once every 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noninferiority margin of extended interval dosing compared to standard dosing	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the efficacy of extended interval and standard interval dosing	To compare the correlation of extended interval and standard interval dosing, as based on a combination of time-to-treatment discontinuation (TTD) and overall survival (OS). This secondary analysis will include all patients who received at least one dose	2 years

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Mark Ratain, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Estimated): April 12, 2026
• Study Completion (Estimated): April 12, 2026

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Pembrolizumab
• Other Study ID Numbers: IRB19-1718

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes