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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)
Sponsor: Merck Sharp & Dohme LLC
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.
Official 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 (KEYVIBE-008)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
460
Start Date
2022-03-24
Completion Date
2027-06-07
Last Updated
2025-07-08
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (140)
Infirmary Cancer Care ( Site 0022)
Mobile, Alabama, United States
Los Angeles Hematology Oncology Medical Group ( Site 0006)
Los Angeles, California, United States
VA West Los Angeles Medical Center ( Site 0004)
Los Angeles, California, United States
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)
Boca Raton, Florida, United States
Fort Wayne Medical Oncology and Hematology ( Site 0013)
Fort Wayne, Indiana, United States
Dana-Farber Cancer Institute ( Site 0018)
Boston, Massachusetts, United States
Cancer and Hematology Centers of Western Michigan ( Site 0001)
Grand Rapids, Michigan, United States
Hattiesburg Clinic Hematology/Oncology ( Site 0003)
Hattiesburg, Mississippi, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)
Lancaster, Pennsylvania, United States
Blue Ridge Cancer Care ( Site 0015)
Blacksburg, Virginia, United States
University of Virginia Cancer Center ( Site 0019)
Charlottesville, Virginia, United States
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)
Mar del Plata, Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Provincial del Centenario ( Site 0205)
Rosario, Santa Fe Province, Argentina
Sanatorio Parque ( Site 0202)
Rosario, Santa Fe Province, Argentina
Nepean Hospital ( Site 2700)
Kingswood, New South Wales, Australia
Calvary Mater Newcastle ( Site 2703)
Waratah, New South Wales, Australia
Frankston Hospital-Oncology and Haematology ( Site 2702)
Frankston, Victoria, Australia
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)
Melbourne, Victoria, Australia
Medizinische Universität Graz ( Site 0504)
Graz, Styria, Austria
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)
Linz, Upper Austria, Austria
Kepler Universitätsklinikum ( Site 0507)
Linz, Upper Austria, 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, Canada
Lakeridge Health ( Site 0102)
Oshawa, Ontario, Canada
Anhui Cancer Hospital ( Site 2915)
Hefei, Anhui, China
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)
Beijing, Beijing Municipality, China
Beijing Peking Union Medical College Hospital ( Site 2921)
Beijing, Beijing Municipality, China
Fujian Provincial Cancer Hospital-oncology department ( Site 2904)
Fuzhou, Fujian, China
Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)
Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 2916)
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2912)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 2922)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 2907)
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University ( Site 2913)
Suzhou, Jiangsu, China
Jilin Cancer Hospital-GCP office ( Site 2909)
Changchun, Jilin, China
The First Hospital of Jilin University ( Site 2914)
Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)
Xi'an, Shaanxi, China
Shanghai Chest Hospital-Oncology department ( Site 2900)
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center ( Site 2908)
Shanghai, Shanghai Municipality, China
Sichuan Cancer hospital. ( Site 2923)
Chengdu, Sichuan, China
West China Hospital Sichuan University ( Site 2903)
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital-Oncology ( Site 2919)
Hangzhou, Zhejiang, China
Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)
Oulu, North Ostrobothnia, Finland
Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)
Vaasa, Pohjanmaa, Finland
Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)
Turku, Southwest Finland, Finland
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)
Marseille, Bouches-du-Rhone, France
CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)
Toulouse, Haute-Garonne, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 0803)
Limoges, Haute-Vienne, France
Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)
Heidelberg, Baden-Wurttemberg, Germany
Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)
Immenhausen, Hesse, Germany
Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901)
Hanover, Lower Saxony, Germany
LungenClinic Grosshansdorf-Onkologie ( Site 0903)
Großhansdorf, Schleswig-Holstein, Germany
SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)
Gera, Thuringia, Germany
Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)
Athens, Attica, Greece
Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)
Athens, Attica, Greece
Metropolitan Hospital ( Site 1001)
Athens, Attica, Greece
University General Hospital of Heraklion ( Site 1004)
Heraklion, Irakleio, Greece
European Interbalkan Medical Center ( Site 1000)
Thessaloniki, Greece
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)
Kecskemét, Bács-Kiskun county, Hungary
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)
Győr, Győr-Moson-Sopron, Hungary
Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)
Törökbálint, Pest County, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)
Kaposvár, Somogy County, Hungary
St. James's Hospital ( Site 1200)
Dublin, Ireland
Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)
Dublin, Ireland
Rambam Health Care Campus-Oncology ( Site 1301)
Haifa, Israel
Shaare Zedek Medical Center-Oncology ( Site 1300)
Jerusalem, Israel
Sheba Medical Center-ONCOLOGY ( Site 1302)
Ramat Gan, Israel
Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)
Naples, Campania, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)
Milan, Lombardy, Italy
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403)
Rozzano, Milano, Italy
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400)
Rome, Roma, Italy
Aichi Cancer Center ( Site 3016)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 3002)
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 3012)
Matsuyama, Ehime, Japan
Kurume University Hospital ( Site 3014)
Kurume, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 3015)
Sapporo, Hokkaido, Japan
Kanazawa University Hospital ( Site 3006)
Kanazawa, Ishikawa-ken, Japan
Kanagawa Cancer Center ( Site 3004)
Yokohama, Kanagawa, Japan
Sendai Kousei Hospital ( Site 3001)
Sendai, Miyagi, Japan
Niigata Cancer Center Hospital ( Site 3005)
Niigata, Niigata, Japan
Kansai Medical University Hospital ( Site 3009)
Hirakata, Osaka, Japan
Shizuoka Cancer Center ( Site 3007)
Nakatogari, Shizuoka, Japan
Cancer Institute Hospital of JFCR ( Site 3003)
Koto, Tokyo, Japan
National Hospital Organization Kyushu Medical Center ( Site 3013)
Fukuoka, Japan
Okayama University Hospital ( Site 3011)
Okayama, Japan
Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)
Klaipėda, Klaipedos Miestas, Lithuania
National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)
Vilnius, Vilniaus Miestas, Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)
Kaunas, Lithuania
Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)
Guadalajara, Jalisco, Mexico
Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)
Guadalajara, Jalisco, Mexico
Arké SMO S.A. de C.V. ( Site 0401)
Mexico City, Mexico City, Mexico
iCan Oncology Center Centro Medico AVE ( Site 0406)
Monterrey, Nuevo León, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0410)
Oaxaca City, Mexico
Ziekenhuis Rijnstate ( Site 1606)
Arnhem, Gelderland, Netherlands
Maastricht UMC+-Pulmonary disease ( Site 1602)
Maastricht, Limburg, Netherlands
Jeroen Bosch Hospital-Pulmonology ( Site 1605)
's-Hertogenbosch, North Brabant, Netherlands
Isala, locatie Zwolle-Poli Longziekten ( Site 1612)
Zwolle, Overijssel, Netherlands
Medische Centrum Leeuwarden ( Site 1619)
Leeuwarden, Provincie Friesland, Netherlands
Erasmus Medisch Centrum ( Site 1621)
Rotterdam, South Holland, Netherlands
Martini Ziekenhuis ( Site 1618)
Groningen, Netherlands
Przychodnia Lekarska KOMED ( Site 1701)
Konin, Greater Poland Voivodeship, Poland
Med-Polonia Sp. z o. o. ( Site 1710)
Poznan, Greater Poland Voivodeship, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709)
Siedlce, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1700)
Warsaw, Masovian Voivodeship, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703)
Przemyśl, Podkarpackie Voivodeship, Poland
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706)
Prabuty, Pomeranian Voivodeship, Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)
Bystra, Silesian Voivodeship, Poland
Champalimaud Foundation ( Site 1812)
Lisbon, Lisbon District, Portugal
Hospital CUF Descobertas ( Site 1815)
Lisbon, Lisbon District, Portugal
Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813)
Porto, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810)
Porto, Portugal
MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905)
Bucharest, București, Romania
Centrul medical Focus ( Site 1903)
Bucharest, București, Romania
Cardiomed SRL Cluj-Napoca ( Site 1900)
Cluj-Napoca, Cluj, Romania
Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904)
Craiova, Dolj, Romania
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1901)
Craiova, Dolj, Romania
Cabinet Medical Oncomed ( Site 1902)
Timișoara, Timiș County, Romania
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)
Hwasun, Jeonranamdo, South Korea
Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)
Deagu, Taegu-Kwangyokshi, South Korea
Chungnam national university hospital-Department of Internal Medicine ( Site 2802)
Daejeon, Taejon-Kwangyokshi, South Korea
Korea University Guro Hospital-Internal Medicine ( Site 2803)
Seoul, South Korea
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102)
Madrid, Madrid, Comunidad de, Spain
H.R.U Málaga - Hospital General-Oncology ( Site 2104)
Málaga, Malaga, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100)
Barcelona, Spain
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103)
Seville, Spain
Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402)
Bornova, İzmir, Turkey (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407)
Adana, Turkey (Türkiye)
Hacettepe Universitesi-oncology hospital ( Site 2409)
Ankara, Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 2406)
Ankara, Turkey (Türkiye)
Ankara Bilkent City Hospital ( Site 2403)
Ankara, Turkey (Türkiye)
Medipol University Medical Faculty-oncology ( Site 2400)
Istanbul, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401)
Istanbul, Turkey (Türkiye)
I.E.U. Medical Point Hastanesi-Oncology ( Site 2408)
Izmir, Turkey (Türkiye)
The Christie-Clinical Research Facility ( Site 2607)
Manchester, England, United Kingdom
Mount Vernon Hospital ( Site 2602)
Northwood, Hillingdon, United Kingdom
Heartlands Hospital-Oncology Research ( Site 2604)
Birmingham, United Kingdom