Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
- Conditions
- Metastatic Cancer
- Interventions
- Registration Number
- NCT04295863
- Lead Sponsor
- University of Chicago
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 264
- 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
-
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard interval dosing Nivolumab Standard - standard interval dosing Pembrolizumab Standard - extended interval dosing Pembrolizumab Extended - extended interval dosing Nivolumab Extended -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (2)
University Of Chicago Medicine Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
SSM Health Cancer Care
🇺🇸Madison, Wisconsin, United States