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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab/Vibostolimab Co-Formulation: 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 placebo: Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)
Etoposide: Etoposide 100 mg/m\^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles
Cisplatin: Cisplatin 75 mg/m\^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
Atezolizumab: Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.
Carboplatin: Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
Study 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.
Eligibility
Primary outcome measure(s)
- Overall Survival (OS) — Up to approximately 25 months
Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data.
Trial sites (140)
| Facility | City | Region | Status |
|---|---|---|---|
| Infirmary Cancer Care ( Site 0022) | Mobile | Alabama | |
| Los Angeles Hematology Oncology Medical Group ( Site 0006) | Los Angeles | California | |
| VA West Los Angeles Medical Center ( Site 0004) | Los Angeles | California | |
| Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014) | Boca Raton | Florida | |
| Fort Wayne Medical Oncology and Hematology ( Site 0013) | Fort Wayne | Indiana | |
| Dana-Farber Cancer Institute ( Site 0018) | Boston | Massachusetts | |
| Cancer and Hematology Centers of Western Michigan ( Site 0001) | Grand Rapids | Michigan | |
| Hattiesburg Clinic Hematology/Oncology ( Site 0003) | Hattiesburg | Mississippi | |
| Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005) | Lancaster | Pennsylvania | |
| Blue Ridge Cancer Care ( Site 0015) | Blacksburg | Virginia | |
| University of Virginia Cancer Center ( Site 0019) | Charlottesville | Virginia | |
| Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203) | Ciudad Autonoma de Buenos Aires | Buenos Aires | |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) | Mar del Plata | Buenos Aires | |
| Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200) | Buenos Aires | Buenos Aires F.D. | |
| Hospital Provincial del Centenario ( Site 0205) | Rosario | Santa Fe Province | |
| Sanatorio Parque ( Site 0202) | Rosario | Santa Fe Province | |
| Nepean Hospital ( Site 2700) | Kingswood | New South Wales | |
| Calvary Mater Newcastle ( Site 2703) | Waratah | New South Wales | |
| Frankston Hospital-Oncology and Haematology ( Site 2702) | Frankston | Victoria | |
| Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701) | Melbourne | Victoria | |
| Medizinische Universität Graz ( Site 0504) | Graz | Styria | |
| Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505) | Linz | Upper Austria | |
| Kepler Universitätsklinikum ( Site 0507) | Linz | Upper Austria | |
| Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0502) | Vienna | Austria | |
| Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501) | Vienna | Austria | |
| Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106) | Kingston | Ontario | |
| Lakeridge Health ( Site 0102) | Oshawa | Ontario | |
| Anhui Cancer Hospital ( Site 2915) | Hefei | Anhui | |
| Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901) | Beijing | Beijing Municipality | |
| Beijing Peking Union Medical College Hospital ( Site 2921) | Beijing | Beijing Municipality | |
| Fujian Provincial Cancer Hospital-oncology department ( Site 2904) | Fuzhou | Fujian | |
| Harbin Medical University Cancer Hospital-oncology of department ( Site 2920) | Harbin | Heilongjiang | |
| Henan Cancer Hospital ( Site 2916) | Zhengzhou | Henan | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2912) | Wuhan | Hubei | |
| Hubei Cancer Hospital ( Site 2922) | Wuhan | Hubei | |
| Hunan Cancer Hospital ( Site 2907) | Changsha | Hunan | |
| The First Affiliated Hospital of Soochow University ( Site 2913) | Suzhou | Jiangsu | |
| Jilin Cancer Hospital-GCP office ( Site 2909) | Changchun | Jilin | |
| The First Hospital of Jilin University ( Site 2914) | Changchun | Jilin | |
| The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910) | Xi'an | Shaanxi |
+ 100 more sites — see the full list on the official registry below.
On this site
📄 Tecentriq (atezolizumab) drug profile →More Merck Sharp & Dohme LLC trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05224141 on ClinicalTrials.gov ↗ ← All trials in Italy