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)

Phase 3 Active not recruiting 460 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

Timeline

Start: 2022-03-24
Primary completion: 2024-06-04
Completion: 2027-06-07

Outcome

Missed primary endpoint

registry analysis (superiority test); Pembrolizumab/Vibostolimab vs Atezolizumab; p = 0.9762; Hazard Ratio (HR) 1.26 (95% CI 1.00 to 1.59); Log Rank NCT05224141 ↗

Publications

Shapira-Frommer R, Niu J, Perets R, Peters S, Shouse G, Lugowska I, Garassino MC, Sands J, Keenan T, Zhao B, Healy J, Ahn MJ. The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies. Future Oncol. 2024;20(27):1983-1991. doi: 10.1080/14796694.2024.2343272. Epub 2024 Sep 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Vibostolimab	Monoclonal antibody	200 mg	Intravenous
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Background	Etoposide	Small molecule	100 mg/m2	Intravenous