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

Metastatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04295863
• Other study ID #: IRB19-1718
• Status: Recruiting
• Phase: Phase 1
• Start date: June 25, 2020
• Est. completion date: April 12, 2025

Study information

• Verified date: April 2023
• Source: University of Chicago
• Contact: Personalized Cancer Care Consortium
• Phone: 773.702.1220
• Email: PhaseIICRA[@]medicine.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: April 12, 2025
• Est. primary completion date: April 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Intervention

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

Locations

Country	Name	City	State
United States	University Of Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois
United States	SSM Health Cancer Care	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2 years