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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

460

Participants

Timeline

Start Date

March 24, 2022

Primary Completion Date

June 4, 2024

Study Completion Date

June 7, 2027

Conditions
Small Cell Lung Carcinoma
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.

Trial Locations (140)

1140

Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0502), Vienna

1210

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501), Vienna

2002

Hospital Provincial del Centenario ( Site 0205), Rosario

2045

Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1101), Törökbálint

2298

Calvary Mater Newcastle ( Site 2703), Waratah

2747

Nepean Hospital ( Site 2700), Kingswood

3021

Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701), Melbourne

3199

Frankston Hospital-Oncology and Haematology ( Site 2702), Frankston

4020

Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505), Linz

4021

Kepler Universitätsklinikum ( Site 0507), Linz

6000

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105), Kecskemét

7400

Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104), Kaposvár

8036

Medizinische Universität Graz ( Site 0504), Graz

9024

Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102), Győr

11527

Sotiria Thoracic Diseases Hospital of Athens ( Site 1003), Athens

13915

Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805), Marseille

17601

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005), Lancaster

20089

Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403), Rozzano

20133

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401), Milan

20520

Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701), Turku

22903

University of Virginia Cancer Center ( Site 0019), Charlottesville

22927

LungenClinic Grosshansdorf-Onkologie ( Site 0903), Großhansdorf

24060

Blue Ridge Cancer Care ( Site 0015), Blacksburg

28041

Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102), Madrid

29011

H.R.U Málaga - Hospital General-Oncology ( Site 2104), Málaga

30625

Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901), Hanover

31400

CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800), Toulouse

33486

Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014), Boca Raton

34214

Medipol University Medical Faculty-oncology ( Site 2400), Istanbul

34376

Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907), Immenhausen

34722

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401), Istanbul

35015

Chungnam national university hospital-Department of Internal Medicine ( Site 2802), Daejeon

35100

Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402), Bornova

35575

I.E.U. Medical Point Hastanesi-Oncology ( Site 2408), Izmir

36607

Infirmary Cancer Care ( Site 0022), Mobile

39401

Hattiesburg Clinic Hematology/Oncology ( Site 0003), Hattiesburg

41009

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103), Seville

41404

Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801), Deagu

44280

Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407), Guadalajara

44680

Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403), Guadalajara

46804

Fort Wayne Medical Oncology and Hematology ( Site 0013), Fort Wayne

49503

Cancer and Hematology Centers of Western Michigan ( Site 0001), Grand Rapids

58128

Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800), Hwasun

64710

iCan Oncology Center Centro Medico AVE ( Site 0406), Monterrey

65130

Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700), Vaasa

68020

Centro de Investigacion Clinica de Oaxaca ( Site 0410), Oaxaca City

69126

Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905), Heidelberg

71500

University General Hospital of Heraklion ( Site 1004), Heraklion

80131

Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402), Naples

87042

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 0803), Limoges

90017

Los Angeles Hematology Oncology Medical Group ( Site 0006), Los Angeles

90073

VA West Los Angeles Medical Center ( Site 0004), Los Angeles

90220

Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702), Oulu

92288

Klaipeda University Hospital-Oncology chemotherapy ( Site 1502), Klaipėda

100142

Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901), Beijing

100730

Beijing Peking Union Medical College Hospital ( Site 2921), Beijing

130000

Jilin Cancer Hospital-GCP office ( Site 2909), Changchun

130021

The First Hospital of Jilin University ( Site 2914), Changchun

150000

Harbin Medical University Cancer Hospital-oncology of department ( Site 2920), Harbin

200030

Shanghai Chest Hospital-Oncology department ( Site 2900), Shanghai

200032

Fudan University Shanghai Cancer Center ( Site 2908), Shanghai

200385

Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904), Craiova

200746

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1901), Craiova

215006

The First Affiliated Hospital of Soochow University ( Site 2913), Suzhou

230031

Anhui Cancer Hospital ( Site 2915), Hefei

300239

Cabinet Medical Oncomed ( Site 1902), Timișoara

310016

Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906), Hangzhou

310022

Zhejiang Cancer Hospital-Oncology ( Site 2919), Hangzhou

350014

Fujian Provincial Cancer Hospital-oncology department ( Site 2904), Fuzhou

400015

Cardiomed SRL Cluj-Napoca ( Site 1900), Cluj-Napoca

410013

Hunan Cancer Hospital ( Site 2907), Changsha

430048

Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2912), Wuhan

430079

Hubei Cancer Hospital ( Site 2922), Wuhan

450008

Henan Cancer Hospital ( Site 2916), Zhengzhou

610042

Sichuan Cancer hospital. ( Site 2923), Chengdu

611135

West China Hospital Sichuan University ( Site 2903), Chengdu

710061

The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910), Xi'an

3109601

Rambam Health Care Campus-Oncology ( Site 1301), Haifa

5265601

Sheba Medical Center-ONCOLOGY ( Site 1302), Ramat Gan

9103102

Shaare Zedek Medical Center-Oncology ( Site 1300), Jerusalem

02215

Dana-Farber Cancer Institute ( Site 0018), Boston

C1199ABB

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203), Ciudad Autonoma de Buenos Aires

B7600FZO

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201), Mar del Plata

C1431FWO

Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200), Buenos Aires

S2000DVC

Sanatorio Parque ( Site 0202), Rosario

K7L 2V7

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106), Kingston

L1G 2B9

Lakeridge Health ( Site 0102), Oshawa

07548

SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900), Gera

115 26

Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002), Athens

185 47

Metropolitan Hospital ( Site 1001), Athens

570 01

European Interbalkan Medical Center ( Site 1000), Thessaloniki

D08 E9P6

St. James's Hospital ( Site 1200), Dublin

Dublin 9

Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201), Dublin

00144

Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400), Rome

464-8681

Aichi Cancer Center ( Site 3016), Nagoya

277-8577

National Cancer Center Hospital East ( Site 3002), Kashiwa

791-0280

National Hospital Organization Shikoku Cancer Center ( Site 3012), Matsuyama

830-0011

Kurume University Hospital ( Site 3014), Kurume

003-0804

National Hospital Organization Hokkaido Cancer Center ( Site 3015), Sapporo

920-8641

Kanazawa University Hospital ( Site 3006), Kanazawa

241-8515

Kanagawa Cancer Center ( Site 3004), Yokohama

981-0914

Sendai Kousei Hospital ( Site 3001), Sendai

951-8566

Niigata Cancer Center Hospital ( Site 3005), Niigata

573-1191

Kansai Medical University Hospital ( Site 3009), Hirakata

411-8777

Shizuoka Cancer Center ( Site 3007), Nakatogari

135-8550

Cancer Institute Hospital of JFCR ( Site 3003), Koto

810-8563

National Hospital Organization Kyushu Medical Center ( Site 3013), Fukuoka

700-8558

Okayama University Hospital ( Site 3011), Okayama

08660

National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501), Vilnius

LT-50161

Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500), Kaunas

06700

Arké SMO S.A. de C.V. ( Site 0401), Mexico City

6815 AD

Ziekenhuis Rijnstate ( Site 1606), Arnhem

6229 HX

Maastricht UMC+-Pulmonary disease ( Site 1602), Maastricht

5223 GZ

Jeroen Bosch Hospital-Pulmonology ( Site 1605), 's-Hertogenbosch

8025 AB

Isala, locatie Zwolle-Poli Longziekten ( Site 1612), Zwolle

8934 AD

Medische Centrum Leeuwarden ( Site 1619), Leeuwarden

3015 GD

Erasmus Medisch Centrum ( Site 1621), Rotterdam

9728 NT

Martini Ziekenhuis ( Site 1618), Groningen

62-500

Przychodnia Lekarska KOMED ( Site 1701), Konin

60-693

Med-Polonia Sp. z o. o. ( Site 1710), Poznan

08-110

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709), Siedlce

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1700), Warsaw

37-700

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703), Przemyśl

82-550

Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706), Prabuty

43-360

Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707), Bystra

1400-038

Champalimaud Foundation ( Site 1812), Lisbon

1998-018

Hospital CUF Descobertas ( Site 1815), Lisbon

4099-001

Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813), Porto

4200-072

Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810), Porto

022343

MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905), Bucharest

022548

Centrul medical Focus ( Site 1903), Bucharest

Unknown

Korea University Guro Hospital-Internal Medicine ( Site 2803), Seoul

08035

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100), Barcelona

01250

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407), Adana

06230

Hacettepe Universitesi-oncology hospital ( Site 2409), Ankara

06520

Memorial Ankara Hastanesi-Medical Oncology ( Site 2406), Ankara

06800

Ankara Bilkent City Hospital ( Site 2403), Ankara

M20 4BX

The Christie-Clinical Research Facility ( Site 2607), Manchester

HA6 2RN

Mount Vernon Hospital ( Site 2602), Northwood

B9 5SS

Heartlands Hospital-Oncology Research ( Site 2604), Birmingham

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY