Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
IRB19-1718
- NCT ID:
NCT04295863
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab Standard | | standard interval dosing |
Pembrolizumab Standard | | standard interval dosing |
Nivolumab Extended | | extended interval dosing |
Pembrolizumab Extended | | extended interval dosing |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
standard interval dosing | Experimental | | - Nivolumab Standard
- Pembrolizumab Standard
|
extended interval dosing | Experimental | | - Nivolumab Extended
- Pembrolizumab Extended
|
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)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Noninferiority margin of extended interval dosing compared to standard dosing |
Time Frame: | 2 years |
Safety Issue: | |
Description: | 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
Measure: | Compare the efficacy of extended interval and standard interval dosing |
Time Frame: | 2 years |
Safety Issue: | |
Description: | 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 |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Chicago |
Last Updated
December 21, 2020