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

NCT04295863 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB19-1718
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 2

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.

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Noninferiority margin of extended interval dosing compared to standard dosing

  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.

  2 years

Secondary Outcomes (1)

• Compare the efficacy of extended interval and standard interval dosing

  2 years

Study Arms (2)

standard interval dosing

EXPERIMENTAL

Drug: Nivolumab Standard; Drug: Pembrolizumab Standard

extended interval dosing

EXPERIMENTAL

Drug: Nivolumab Extended; Drug: Pembrolizumab Extended

Interventions

Nivolumab Standard DRUG

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

standard interval dosing

Pembrolizumab Standard DRUG

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

standard interval dosing

Nivolumab Extended DRUG

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

extended interval dosing

Pembrolizumab Extended DRUG

For patients on extended interval dosing of pembrolizumab therapy will consist of 200mg IV once every 6 weeks

extended interval dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with locally advandced or metastatic cancer whose physician has determined they are candidates for treatment with nivolumab or pembrolizumab
• years old or older
• Measurable disease per RECIST criteria

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (2)

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

SSM Health Cancer Care

Madison, Wisconsin, 53717, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Ratain, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Personalized Cancer Care Consortium

CONTACT

773.702.1220; PhaseIICRA@medicine.bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: March 5, 2020
• Study Start: June 25, 2020
• Primary Completion: April 12, 2026
• Study Completion: April 12, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (2)