Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

739

Participants

Timeline

Start Date

March 24, 2022

Primary Completion Date

September 24, 2024

Study Completion Date

January 9, 2026

Conditions
Metastatic Non-Small Cell Lung Cancer
Interventions
BIOLOGICAL

Pembrolizumab/Vibostolimab

Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations

DRUG

Carboplatin

Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations

DRUG

Cisplatin

Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations

DRUG

Paclitaxel

Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations

DRUG

Nab-paclitaxel

Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations

DRUG

Pemetrexed

Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision

BIOLOGICAL

Pembrolizumab

Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations

Trial Locations (149)

100

National Taiwan University Hospital-Oncology ( Site 2255), Taipei

333

Chang Gung Medical Foundation-Linkou Branch ( Site 2251), Taoyuan District

704

NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252), Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254), Kaohsiung City

1140

Klinik Penzing-2. Lungenabteilung ( Site 0702), Vienna

1210

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701), Vienna

2000

Sanatorio Parque ( Site 0205), Rosario

2002

Hospital Provincial del Centenario ( Site 0212), Rosario

4020

Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705), Linz

4021

Kepler Universitätsklinikum ( Site 0707), Linz

6020

Medizinische Universitaet Innsbruck ( Site 0703), Innsbruck

8036

Medizinische Universität Graz ( Site 0704), Graz

10210

Chulabhorn Hospital ( Site 2305), Lak Si

10700

Faculty of Medicine Siriraj Hospital ( Site 2304), Bangkok

11794

Stony Brook University-Cancer Center ( Site 0013), Stony Brook

13353

Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913, Berlin

15006

CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106), A Coruña

17604

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012), Lancaster

22030

Trakya University-Medical Oncology ( Site 1203), Edirne

22903

University of Virginia Cancer Center ( Site 0018), Charlottesville

23538

Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902), Lübeck

25279

CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304), Saltillo

28040

Hospital Clinico San Carlos-Oncology Department ( Site 1107), Madrid

29414

Charleston Oncology ( Site 0019), Charleston

32224

Mayo Clinic in Florida ( Site 0022), Jacksonville

34662

Acibadem Altunizade Hospital-Oncology ( Site 1207), Üsküdar / Stanbul

34722

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209), Istanbul

34766

Umraniye Training and Research Hospital-medical oncology ( Site 1206), Istanbul

35001

Hospital Insular de Gran Canaria-Oncology ( Site 1102), Las Palmas de Gran Canaria

35015

Chungnam national university hospital-Department of Internal Medicine ( Site 2203), Daejeon

35392

UKGM Gießen/Marburg-Medical Clinic V ( Site 0912), Giessen

40002

Faculty of Medicine - Khon Kaen University ( Site 2303), Muang

40447

China Medical University Hospital ( Site 2253), Taichung

41009

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103), Seville

41404

Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202), Deagu

44263

GEFOS Gesellschaft f. onkologische Studien ( Site 0909), Dortmund

44280

Hospital Civil Fray Antonio Alcalde ( Site 0307), Guadalajara

45067

CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806), Orléans

49055

Institut de Cancérologie de l'Ouest ( Site 0802), Angers

49241

Pusan National University Hospital ( Site 2205), Busan

49503

Cancer and Hematology Centers of Western Michigan ( Site 0002), Grand Rapids

50009

Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105), Zaragoza

50200

Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301), Chiang Mai

55905

Mayo Clinic in Rochester, Minnesota ( Site 0030), Rochester

58128

Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201), Hwasun

59037

Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th, Lille

60608

Mount Sinai Hospital ( Site 0011), Chicago

60637

University of Chicago Medical Center ( Site 0015), Chicago

69373

CENTRE LEON BERARD ( Site 0803), Lyon

74370

Centre Hospitalier d'Annecy ( Site 0807), Epagny Metz-Tessy

80528

University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031), Fort Collins

80909

UCHealth Memorial Hospital-Heme Onc ( Site 0003), Colorado Springs

84000

Centre Hospitalier d'Avignon ( Site 0810), Avignon

90110

Songklanagarind hospital ( Site 2302), Hat Yai

100142

Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602), Beijing

110221

Administradora Country S.A. - Clinica del Country ( Site 0601), Bogotá

132000

Jilin Cancer Hospital-oncology department ( Site 2603), Changchun

150000

Harbin Medical University Cancer Hospital-oncology of department ( Site 2604), Harbin

200001

Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606), Valledupar

200032

Fudan University Shanghai Cancer Center ( Site 2616), Shanghai

200433

Shanghai Pulmonary Hospital-Oncology Department ( Site 2601), Shanghai

210000

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (, Nanjing

230001

Oncomedica S.A.-Oncomedica S.A ( Site 0609), Montería

230036

Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619), Hefei

250117

Shandong Cancer Hospital-Oncology Department ( Site 2630), Jinan

300060

Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606), Tianjin

310003

The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613), Hangzhou

310016

Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615), Hangzhou

310022

Zhejiang Cancer Hospital-Oncology ( Site 2612), Hangzhou

310052

The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site, Hangzhou

330006

The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625), Nanchang

The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624), Nanchang

350014

Fujian Provincial Cancer Hospital-oncology department ( Site 2621), Fuzhou

361003

The First Affiliated hospital of Xiamen University ( Site 2626), Xiamen

410008

Xiangya Hospital Central South University-Oncology department ( Site 2627), Changsha

410011

The Second Xiangya Hospital of Central South University ( Site 2623), Changsha

410013

Hunan Cancer Hospital ( Site 2622), Changsha

430022

Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618), Wuhan

430030

Tongji Hospital Tongji Medical,Science & Technology ( Site 2617), Wuhan

450000

Henan Cancer Hospital ( Site 2608), Zhengzhou

510515

Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (, Guangzhou

610041

Sichuan Cancer hospital ( Site 2628), Chengdu

West China Hospital of Sichuan University ( Site 2610), Chengdu

644000

The Second People's Hospital of Yibin ( Site 2629), Yibin

660001

Oncologos del Occidente ( Site 0608), Pereira

710061

The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607), Xi'an

1240000

Centro de Investigación Oncológica del Norte ( Site 0504), Antofagasta

1428666

Showa University Hospital ( Site 2403), Shinagawa

2520598

ONCOCENTRO APYS-ACEREY ( Site 0503), Viña del Mar

3109601

Rambam Health Care Campus-Oncology ( Site 1303), Haifa

4070196

Biocenter ( Site 0514), Concepción

4428164

Meir Medical Center-oncology ( Site 1301), Kfar Saba

4800827

James Lind Centro de Investigación del Cáncer ( Site 0502), Temuco

4810148

CIDO SpA-Oncology ( Site 0508), Temuco

5265601

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

6423906

Sourasky Medical Center-Oncology ( Site 1305), Tel Aviv

6900941

FALP-UIDO ( Site 0505), Santiago

7560908

Centro de Oncología de Precisión ( Site 0515), Santiago

8420383

Bradfordhill ( Site 0510), Santiago

9013102

Shaare Zedek Medical Center-Oncology ( Site 1306), Jerusalem

04074

New England Cancer Specialists ( Site 0008), Scarborough

B1884BBF

Centro de Oncología e Investigación de Buenos Aires ( Site 0203), Berazategui

B7600FZO

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204), Mar del Plata

C1199ABB

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209), ABB

C1431FWO

Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202), Buenos Aires

F5300COE

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206), La Rioja

59075-740

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403), Natal

91350-200

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405), Porto Alegre

89010-340

Clínica de Oncologia Reichow ( Site 0407), Blumenau

20230-130

Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406), Rio de Janeiro

01321-001

Hospital Paulistano ( Site 0401), São Paulo

050030

Fundación Colombiana de Cancerología Clínica Vida ( Site 0603), Medellín

83800 Cedex 9

HIA Sainte Anne ( Site 0804), Toulon

07548

SRH Wald-Klinikum Gera ( Site 0911), Gera

791-0280

National Hospital Organization Shikoku Cancer Center ( Site 2414), Matsuyama

791-0295

Ehime University Hospital ( Site 2411), Tōon

673-8558

Hyogo Cancer Center-Thoracic Oncology ( Site 2409), Akashi

920-8641

Kanazawa University Hospital ( Site 2407), Kanazawa

241-8515

Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405), Yokohama

981-1293

Miyagi Cancer Center ( Site 2401), Natori-shi

573-1191

Kansai Medical University Hospital ( Site 2415), Hirakata

362-0806

Saitama Prefectural Cancer Center ( Site 2406), Ina-machi

411-8777

Shizuoka Cancer Center ( Site 2408), Nakatogari

135-8550

Japanese Foundation for Cancer Research ( Site 2402), Koto

810-8563

National Hospital Organization Kyushu Medical Center ( Site 2413), Fukuoka

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 2412), Fukuoka

700-8558

Okayama University Hospital ( Site 2410), Okayama

113-8603

Nippon Medical School Hospital ( Site 2404), Tokyo

06700

Arké SMO S.A. de C.V. ( Site 0301), Mexico City

06760

Alivia Clínica de Alta Especialidad ( Site 0310), Mexico City

62-500

Przychodnia Lekarska KOMED ( Site 1902), Konin

60-693

Med-Polonia Sp. z o. o. ( Site 1909), Poznan

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903), Bydgoszcz

02-781

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

04-125

Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908), Warsaw

37-700

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904), Przemyśl

82-550

Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906), Prabuty

43-360

Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907), Bystra

05505

Asan Medical Center ( Site 2206), Songpa-gu

Unknown

Korea University Guro Hospital-Internal Medicine ( Site 2204), Seoul

Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502), Leicester

08035

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101), Barcelona

01250

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208), Adana

06230

Hacettepe Universitesi-oncology hospital ( Site 1202), Ankara

06680

Liv Hospital Ankara-Oncology ( Site 1205), Ankara

06800

Ankara City Hospital ( Site 1204), Ankara

SW10 9NH

Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501), London

EC1A 7BE

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506), London

NW1 2PG

University College London Hospital-Cancer Clinical Trials Unit ( Site 1509), London-Camden

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY