Cody Peer, PhD, from the National Institutes of Health, is conducting a randomized research study comparing the dosing intervals of two drugs, nivolumab and pembrolizumab, in patients with locally advanced or metastatic cancers.
The study aims to determine if these drugs can be administered less frequently than the currently approved dosing schedule.
The primary outcome measure of the study is the noninferiority of extended interval dosing compared to standard dosing.
The researchers will evaluate the drug trough levels in the blood and categorize patients as either successful or unsuccessful based on achieving drug trough levels above the target concentration of 1.5 µg/mL.
This assessment will be conducted over a period of two years.
Additionally, the study will analyze the secondary outcome measure of comparing the efficacy of extended interval dosing with standard interval dosing.
This analysis will consider a combination of time-to-treatment discontinuation (TTD) and overall survival (OS) and will include all patients who have received at least one dose of the drugs.
The goal is to determine if extended interval dosing maintains comparable efficacy to the standard dosing schedule.
The inclusion criteria for participants in this study are patients with locally advanced or metastatic cancer who have been identified by their physicians as suitable candidates for treatment with nivolumab or pembrolizumab.
The patients must be 18 years of age or older and have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
However, there are exclusion criteria for the study. Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy are excluded.
Additionally, patients whose treatment plan involves receiving ipilimumab or other anti-CTLA4 monoclonal antibodies in combination with nivolumab or pembrolizumab are not eligible for this trial.
It's important to note that patients whose planned treatment involves the combination of anti-PD-1 and a tyrosine kinase inhibitor or the combination of traditional cytotoxic chemotherapy and anti-PD-1 are eligible to participate.
In conclusion, Dr. Peer is conducting a randomized research study to compare the dosing intervals of nivolumab and pembrolizumab in patients with locally advanced or metastatic cancers.
The study aims to determine if extended interval dosing can maintain drug trough levels above the target concentration, and if it is as effective as the standard dosing schedule.
The findings from this study may have implications for optimizing the dosing regimens of these drugs, potentially improving treatment outcomes for patients with advanced cancers.