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

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ClinicalTrials.gov Identifier: NCT04295863
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Drug: Nivolumab Standard Drug: Pembrolizumab Standard Drug: Nivolumab Extended Drug: Pembrolizumab Extended Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 25, 2020
Estimated Primary Completion Date : April 12, 2023
Estimated Study Completion Date : April 12, 2025

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Noninferiority margin of extended interval dosing compared to standard dosing [ Time Frame: 2 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.


Secondary Outcome Measures :
  1. Compare the efficacy of extended interval and standard interval dosing [ Time Frame: 2 years ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295863


Contacts
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Contact: Personalized Cancer Care Consortium 773.702.1220 PhaseIICRA@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
University Of Chicago Medicine Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Clinical Trials Intake    855-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Principal Investigator: Mark Ratain, MD         
United States, Wisconsin
SSM Health Cancer Care Recruiting
Madison, Wisconsin, United States, 53717
Contact: Terri Roberts    608-410-2769    terri.roberts@ssmhealth.com   
Contact: Nicole Schultz    608-410-2774    nicole.schultz1@ssmhealth.com   
Principal Investigator: Amit Sanyal, MD         
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Mark Ratain, MD University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04295863    
Other Study ID Numbers: IRB19-1718
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020

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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
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Pembrolizumab
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action