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

Primary Purpose

Metastatic Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Nivolumab Standard

Pembrolizumab Standard

Nivolumab Extended

Pembrolizumab Extended

About this trial

This is an interventional treatment trial for Metastatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

University Of Chicago Medicine Comprehensive Cancer CenterRecruiting
SSM Health Cancer CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

standard interval dosing

extended interval dosing

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Compare the efficacy of extended interval and standard interval dosing

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

Full Information

NCT ID

NCT04295863

First Posted

February 14, 2020

Last Updated

April 26, 2023

Sponsor

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT04295863

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 25, 2020 (Actual)

Primary Completion Date

April 12, 2025 (Anticipated)

Study Completion Date

April 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

4. Oversight

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

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

standard interval dosing

Arm Type

Experimental

Arm Title

extended interval dosing

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nivolumab Standard

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab Standard

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nivolumab Extended

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab Extended

Intervention Description

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

Primary Outcome Measure Information:

Title

Noninferiority margin of extended interval dosing compared to standard dosing

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Compare the efficacy of extended interval and standard interval dosing

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Personalized Cancer Care Consortium

Phone

773.702.1220

PhaseIICRA@medicine.bsd.uchicago.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Ratain, MD

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Of Chicago Medicine Comprehensive Cancer Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trials Intake

Phone

855-702-8222

cancerclinicaltrials@bsd.uchicago.edu

First Name & Middle Initial & Last Name & Degree

Mark Ratain, MD

Facility Name

SSM Health Cancer Care

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53717

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Terri Roberts

Phone

608-410-2769

terri.roberts@ssmhealth.com

First Name & Middle Initial & Last Name & Degree

Nicole Schultz

Phone

608-410-2774

nicole.schultz1@ssmhealth.com

First Name & Middle Initial & Last Name & Degree

Amit Sanyal, MD

12. IPD Sharing Statement

Learn more about this trial

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

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