Title: A phase 3, randomized, double-blind study of MK-7684A in combination with etoposide and platinum followed by MK-7684A vs atezolizumab in combination with etoposide and platinum followed by atezolizumab for the first-line treatment of participants with extensive-stage small cell lung cancer
Responsible Party: Merck Sharp & Dohme LLC
Description: Researchers are conducting a phase 3 study to evaluate a fixed-dose co-formulation of pembrolizumab and vibostolimab (MK-7684A) in combination with chemotherapy, compared to atezolizumab plus chemotherapy in patients with previously untreated, extensive-stage small cell lung cancer (ES-SCLC).
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In the first arm, patients will receive 4 cycles of MK-7684A (200 mg of pembrolizumab and 200 mg of vibostolimab) every 3 weeks, in combination with etoposide (100 mg/m2) and carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) every 3 weeks for roughly 12 weeks. This will be followed by MK-7684A every 3 weeks until conditions for discontinuation are met.
In the second arm, patients will receive 4 cycles of atezolizumab (1200 mg) every 3 weeks, in combination with etoposide (100 mg/m2) and carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) every 3 weeks for roughly 12 weeks. This will be followed by atezolizumab every 3 weeks until conditions for discontinuation are met.
This is a double-blind study. To maintain blinding, saline placebo will be administered in both study arms on day 1 of cycle 1, and then once every 3 weeks thereafter.
The primary outcome is overall survival. Secondary outcomes include progression-free survival, objective response rate, duration of response, adverse events, and more.
To be eligible for this study, patients must be 18 years of age or older and have ES-SCLC in need of first-line therapy. For a complete list of eligibility criteria, please see the reference.
Status: Recruiting
This study is sponsored by Merck Sharp & Dohme LLC.
Reference
ClinicalTrials.gov. Pembrolizumab/vibostolimab (MK-7684A) or atezolizumab in combination with chemotherapy in first line treatment of extensive-stage small cell lung cancer (MK-7684A-008, KEYVIBE-008). NCT05224141. Accessed May 23, 2023.
