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

NCT04295863 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Mark Ratain, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2026-04-12
Completion
2026-04-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04295863 on ClinicalTrials.gov