CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 460 enrolled
Drug / intervention
Pembrolizumab/Vibostolimab Co-Formulation +5 morebiological
Likely dose
Pembrolizumab/Vibostolimab Co-Formulation 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05224141
NCT05224141Phase 3Active
CompareCT.gov

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 (KEYVIBE-008)

Merck Sharp & Dohme LLC·interventional·Posted Feb 4, 2022·Updated Jul 8, 2025

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab/Vibostolimab Co-Formulation, Saline placebo, and 4 other interventions for Small Cell Lung Carcinoma. Active but no longer recruiting, targeting 460 participants across 140 sites in 25 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Carcinoma
CountriesArgentina, Australia, Austria, Canada, China, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
202220232024202520262027
First PostedFeb 4, 2022
Enrollment StartMar 24, 2022
Primary CompletionJun 4, 2024
Study CompletionJun 7, 2027
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.4 years ago

Interventions

Pembrolizumab/Vibostolimab Co-Formulationbiological

Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Saline placebodrug

Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)

Etoposidedrug

Etoposide 100 mg/m\^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles

Cisplatindrug

Cisplatin 75 mg/m\^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Atezolizumabbiological

Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Carboplatindrug

Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.