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RECRUITING
NCT04295863
PHASE1

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

Sponsor: University of Chicago

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

264

Start Date

2020-06-25

Completion Date

2026-04-12

Last Updated

2025-10-01

Healthy Volunteers

No

Interventions

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

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

Locations (2)

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

SSM Health Cancer Care

Madison, Wisconsin, United States