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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT04295863
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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
  • 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
  • Pembrolizumab Extended — DRUG
    For patients on extended interval dosing of pembrolizumab therapy will consist of 200mg IV once every 6 weeks

Study Details

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.

Key Dates

Start date
Jun 25, 2020
Status verified
Sep 2025
Primary completion
Apr 12, 2026
Completion
Apr 12, 2026

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: standard interval dosing
  • Experimental: extended interval dosing

Primary Outcome Measure

Noninferiority margin of extended interval dosing compared to standard dosing [ Time Frame: 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University Of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
Clinical Trials Intake
[email protected]
855-702-8222
Mark Ratain, MD (PRINCIPAL_INVESTIGATOR)
SSM Health Cancer CareMadisonWisconsin53717
Terri Roberts
[email protected]
608-410-2769
Nicole Schultz
[email protected]
608-410-2774
Amit Sanyal, MD (PRINCIPAL_INVESTIGATOR)

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