RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-06-25
Study Completion:2025-04-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04295863

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with locally advandced or metastatic cancer whose physician has determined they are candidates for treatment with nivolumab or pembrolizumab
  2. * 18 years old or older
  3. * Measurable disease per RECIST criteria
  1. * Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy.
  2. * Patients whose treatment plan is to receive ipilimumab or other anti-CTLA4 monoclonal antibody in combination with either nivolumab or pembrolizumab.
  3. * Ipilimumab and nivolumab combination are not eligible for this trial.
  4. * (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)

Contacts and Locations

Study Contact

Personalized Cancer Care Consortium
CONTACT
773.702.1220
PhaseIICRA@medicine.bsd.uchicago.edu

Principal Investigator

Mark Ratain, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University Of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
United States
SSM Health Cancer Care
Madison, Wisconsin, 53717
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Mark Ratain, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-25
Study Completion Date2025-04-12

Study Record Updates

Study Start Date2020-06-25
Study Completion Date2025-04-12

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Cancer