Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05224141
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

DRUG

Saline placebo

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

DRUG

Etoposide

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

DRUG

Cisplatin

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

BIOLOGICAL

Atezolizumab

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

DRUG

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