Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04295863

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

Led by University of Chicago · Updated on 2025-10-01

264

Participants Needed

2

Research Sites

302 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

Actively Recruiting

2

SSM Health Cancer Care

Madison, Wisconsin, United States, 53717

Actively Recruiting

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Research Team

P

Personalized Cancer Care Consortium

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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