Title: A phase 3, multicenter, randomized, double-blind study of MK-7684 with pembrolizumab as a coformulation (MK-7684A) versus pembrolizumab monotherapy as first line treatment for participants with PD-L1 positive metastatic non-small cell lung cancer
Responsible Party: Merck Sharp & Dohme LLC
Description: Researchers are conducting a phase 3 study to compare a coformulation of pembrolizumab and vibostolimab to pembrolizumab alone as first-line treatment for patients with PD-L1-positive, metastatic non-small cell lung cancer (NSCLC).
Patients in the experimental arm will be given a coformation of pembrolizumab (200 mg) and vibostolimab (200 mg) intravenously every 3 weeks for up to 35 administrations. Patients in the active control arm will receive pembrolizumab (200 mg) intravenously every 3 weeks for up to 35 administrations.
The primary outcomes of this study are overall survival in patients with a PD-L1 tumor proportion score (TPS) of 1% or higher, 1% to 49%, and 50% or higher as well as progression-free survival in patients with a PD-L1 TPS of 1% or higher and 50% or higher.
Some secondary outcomes include objective response rate and duration of response across PD-L1 TPS subgroups, changes from baseline in various measures of quality of life across PD-L1 TPS groups, and adverse events.
To be eligible for this study, patients must be 18 years of age or older. They must have a histologically or cytologically confirmed diagnosis of metastatic NSCLC with PD-L1 expression in at least 1% of tumor cells. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by Merck Sharp & Dohme LLC.
Reference ClinicalTrials.gov. Coformulation of pembrolizumab/vibostolimab (MK-7684A) versus pembrolizumab (MK-3475) monotherapy for programmed cell death 1 ligand 1 (PD-L1) positive metastatic non-small cell lung cancer (MK-7684A-003, KEYVIBE-003). NCT04738487. Accessed September 7, 2023.