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)
Who is this study for? Patients with Small Cell Lung Carcinoma
What treatments are being studied? Etoposide+Cisplatin+Carboplatin
Status: Active_not_recruiting
Location: See all (140) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ The main inclusion criteria include but are not limited to the following:
• Has histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) in need of first-line therapy
• Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
• Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
• Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
• Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
• Has a predicted life expectancy of \>3 months
Locations
United States
Alabama
Infirmary Cancer Care ( Site 0022)
Mobile
California
Los Angeles Hematology Oncology Medical Group ( Site 0006)
Los Angeles
VA West Los Angeles Medical Center ( Site 0004)
Los Angeles
Florida
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)
Boca Raton
Indiana
Fort Wayne Medical Oncology and Hematology ( Site 0013)
Fort Wayne
Massachusetts
Dana-Farber Cancer Institute ( Site 0018)
Boston
Michigan
Cancer and Hematology Centers of Western Michigan ( Site 0001)
Grand Rapids
Mississippi
Hattiesburg Clinic Hematology/Oncology ( Site 0003)
Hattiesburg
Pennsylvania
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)
Lancaster
Virginia
Blue Ridge Cancer Care ( Site 0015)
Blacksburg
University of Virginia Cancer Center ( Site 0019)
Charlottesville
Other Locations
Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)
Buenos Aires
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)
Ciudad Autonoma De Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)
Mar Del Plata
Hospital Provincial del Centenario ( Site 0205)
Rosario
Sanatorio Parque ( Site 0202)
Rosario
Australia
Frankston Hospital-Oncology and Haematology ( Site 2702)
Frankston
Nepean Hospital ( Site 2700)
Kingswood
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)
Melbourne
Calvary Mater Newcastle ( Site 2703)
Waratah
Austria
Medizinische Universität Graz ( Site 0504)
Graz
Kepler Universitätsklinikum ( Site 0507)
Linz
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)
Linz
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501)
Vienna
Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0502)
Vienna
Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106)
Kingston
Lakeridge Health ( Site 0102)
Oshawa
China
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)
Beijing
Beijing Peking Union Medical College Hospital ( Site 2921)
Beijing
Jilin Cancer Hospital-GCP office ( Site 2909)
Changchun
The First Hospital of Jilin University ( Site 2914)
Changchun
Hunan Cancer Hospital ( Site 2907)
Changsha
Sichuan Cancer hospital. ( Site 2923)
Chengdu
West China Hospital Sichuan University ( Site 2903)
Chengdu
Fujian Provincial Cancer Hospital-oncology department ( Site 2904)
Fuzhou
Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)
Hangzhou
Zhejiang Cancer Hospital-Oncology ( Site 2919)
Hangzhou
Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)
Harbin
Anhui Cancer Hospital ( Site 2915)
Hefei
Fudan University Shanghai Cancer Center ( Site 2908)
Shanghai
Shanghai Chest Hospital-Oncology department ( Site 2900)
Shanghai
The First Affiliated Hospital of Soochow University ( Site 2913)
Suzhou
Hubei Cancer Hospital ( Site 2922)
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2912)
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)
Xi'an
Henan Cancer Hospital ( Site 2916)
Zhengzhou
Finland
Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)
Oulu
Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)
Turku
Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)
Vaasa
France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 0803)
Limoges
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)
Marseille
CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)
Toulouse
Germany
SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)
Gera
LungenClinic Grosshansdorf-Onkologie ( Site 0903)
Großhansdorf
Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901)
Hanover
Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)
Heidelberg
Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)
Immenhausen
Greece
Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)
Athens
Metropolitan Hospital ( Site 1001)
Athens
Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)
Athens
University General Hospital of Heraklion ( Site 1004)
Heraklion
European Interbalkan Medical Center ( Site 1000)
Thessaloniki
Hungary
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)
Győr
Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)
Kaposvár
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)
Kecskemét
Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)
Törökbálint
Ireland
Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)
Dublin
St. James's Hospital ( Site 1200)
Dublin
Israel
Rambam Health Care Campus-Oncology ( Site 1301)
Haifa
Shaare Zedek Medical Center-Oncology ( Site 1300)
Jerusalem
Sheba Medical Center-ONCOLOGY ( Site 1302)
Ramat Gan
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)
Milan
Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)
Naples
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400)
Rome
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403)
Rozzano
Japan
National Hospital Organization Kyushu Medical Center ( Site 3013)
Fukuoka
Kansai Medical University Hospital ( Site 3009)
Hirakata
Kanazawa University Hospital ( Site 3006)
Kanazawa
National Cancer Center Hospital East ( Site 3002)
Kashiwa
Cancer Institute Hospital of JFCR ( Site 3003)
Koto
Kurume University Hospital ( Site 3014)
Kurume
National Hospital Organization Shikoku Cancer Center ( Site 3012)
Matsuyama
Aichi Cancer Center ( Site 3016)
Nagoya
Shizuoka Cancer Center ( Site 3007)
Nakatogari
Niigata Cancer Center Hospital ( Site 3005)
Niigata
Okayama University Hospital ( Site 3011)
Okayama
National Hospital Organization Hokkaido Cancer Center ( Site 3015)
Sapporo
Sendai Kousei Hospital ( Site 3001)
Sendai
Kanagawa Cancer Center ( Site 3004)
Yokohama
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)
Kaunas
Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)
Klaipėda
National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)
Vilnius
Mexico
Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)
Guadalajara
Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)
Guadalajara
Arké SMO S.A. de C.V. ( Site 0401)
Mexico City
iCan Oncology Center Centro Medico AVE ( Site 0406)
Monterrey
Centro de Investigacion Clinica de Oaxaca ( Site 0410)
Oaxaca City
Netherlands
Jeroen Bosch Hospital-Pulmonology ( Site 1605)
's-hertogenbosch
Ziekenhuis Rijnstate ( Site 1606)
Arnhem
Martini Ziekenhuis ( Site 1618)
Groningen
Medische Centrum Leeuwarden ( Site 1619)
Leeuwarden
Maastricht UMC+-Pulmonary disease ( Site 1602)
Maastricht
Erasmus Medisch Centrum ( Site 1621)
Rotterdam
Isala, locatie Zwolle-Poli Longziekten ( Site 1612)
Zwolle
Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)
Bystra
Przychodnia Lekarska KOMED ( Site 1701)
Konin
Med-Polonia Sp. z o. o. ( Site 1710)
Poznan
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706)
Prabuty
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703)
Przemyśl
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709)
Siedlce
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1700)
Warsaw
Portugal
Champalimaud Foundation ( Site 1812)
Lisbon
Hospital CUF Descobertas ( Site 1815)
Lisbon
Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813)
Porto
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810)
Porto
Republic of Korea
Chungnam national university hospital-Department of Internal Medicine ( Site 2802)
Daejeon
Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)
Deagu
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)
Hwasun
Korea University Guro Hospital-Internal Medicine ( Site 2803)
Seoul
Romania
Centrul medical Focus ( Site 1903)
Bucharest
MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905)
Bucharest
Cardiomed SRL Cluj-Napoca ( Site 1900)
Cluj-napoca
Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904)
Craiova
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1901)
Craiova
Cabinet Medical Oncomed ( Site 1902)
Timișoara
Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100)
Barcelona
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102)
Madrid
H.R.U Málaga - Hospital General-Oncology ( Site 2104)
Málaga
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103)
Seville
Turkey
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407)
Adana
Ankara Bilkent City Hospital ( Site 2403)
Ankara
Hacettepe Universitesi-oncology hospital ( Site 2409)
Ankara
Memorial Ankara Hastanesi-Medical Oncology ( Site 2406)
Ankara
Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402)
Bornova
Medipol University Medical Faculty-oncology ( Site 2400)
Istanbul
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401)
Istanbul
I.E.U. Medical Point Hastanesi-Oncology ( Site 2408)
Izmir
United Kingdom
Heartlands Hospital-Oncology Research ( Site 2604)
Birmingham
The Christie-Clinical Research Facility ( Site 2607)
Manchester
Mount Vernon Hospital ( Site 2602)
Northwood
Time Frame
Start Date: 2022-03-24
Completion Date: 2027-06-07
Participants
Target number of participants: 460
Treatments
Experimental: Pembrolizumab/Vibostolimab
Participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Active_comparator: Atezolizumab
Participants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC