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

Sponsor

University of Chicago (Other)

Overall Status

Recruiting

CT.gov ID

NCT04295863

Collaborator

(none)

264

Enrollment

Locations

Arms

57.6

Anticipated Duration (Months)

132

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer	Drug: Nivolumab Standard Drug: Pembrolizumab Standard Drug: Nivolumab Extended Drug: Pembrolizumab Extended	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

264 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 25, 2020

Anticipated Primary Completion Date :

Apr 12, 2023

Anticipated Study Completion Date :

Apr 12, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: standard interval dosing	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
Experimental: extended interval dosing	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

Arm

Intervention/Treatment

Experimental: standard interval dosing

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

Experimental: extended interval dosing

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

Outcome Measures

Primary Outcome Measures

Noninferiority margin of extended interval dosing compared to standard dosing [2 years]
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.

Secondary Outcome Measures

Compare the efficacy of extended interval and standard interval dosing [2 years]
To compare the correlation of extended interval and standard interval dosing, as based on a combination of time-to-treatment discontinuation (TTD) and overall survival (OS). This secondary analysis will include all patients who received at least one dose

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Of Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois	United States	60637
2	SSM Health Cancer Care	Madison	Wisconsin	United States	53717

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator: Mark Ratain, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Chicago

ClinicalTrials.gov Identifier:

NCT04295863

Other Study ID Numbers:

IRB19-1718

First Posted:

Mar 5, 2020

Last Update Posted:

Dec 28, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Neoplasm Metastasis

Neoplasms

Neoplasms, Second Primary

Pembrolizumab

Nivolumab

Study Results

No Results Posted as of Dec 28, 2021