Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,264

Participants

Timeline

Start Date

April 7, 2021

Primary Completion Date

September 5, 2024

Study Completion Date

January 26, 2026

Conditions
Lung NeoplasmsNon-Small-Cell Lung Carcinoma
Interventions
BIOLOGICAL

Pembrolizumab/Vibostolimab

Coformulation of pembrolizumab (MK-3475) 200mg and vibostolimab (MK-7684) 200mg. Participants receive the coformulation by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years).

BIOLOGICAL

Pembrolizumab

Participants receive 200 mg of pembrolizumab by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years).

Trial Locations (188)

1083

Semmelweis University-Pulmonológiai Klinika ( Site 1209), Budapest

1100

East Avenue Medical Center-Department of Medicine ( Site 1605), Quezon City

Veterans Memorial Medical Center-Section of Oncology ( Site 1608), Quezon City

1121

Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 1204), Budapest

1502

CARDINAL SANTOS MEDICAL CENTER ( Site 1606), San Juan City, Metro Manila

2013

Wits Clinical Research-Wits Clinical Research Bara ( Site 0908), Soweto

2045

Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1208), Törökbálint

2193

Wits Clinical Research ( Site 0900), Johannesburg

2196

Medical Oncology Centre of Rosebank ( Site 0906), Johannesburg

Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0902), Sandton

3233

Mátrai Gyógyintézet ( Site 1214), Kékestető

3900

Abraham Oncology ( Site 0907), Richards Bay

4091

The Oncology Centre ( Site 0905), Durban

5000

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1200), Szolnok

5700

Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1207), Gyula

6000

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1201), Kecskemét

7570

Cape Town Oncology Trials ( Site 0903), Cape Town

8900

Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 1202), Zalaegerszeg

9024

Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia ( Site 1205), Győr

10002

Zhytomyr Regional Oncology Center-Chemotherapy Department ( Site 1103), Zhytomyr

10050

Gleneagles Penang Medical Center-Clinical Research Center (CRC) ( Site 1503), George Town

10065

Memorial Sloan Kettering Cancer Center ( Site 0013), New York

10102

Instituto de Oncologia ( Site 2300), Santo Domingo

10104

CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 2301), Santo Domingo

10330

Chulalongkorn University ( Site 1802), Bangkok

10400

Ramathibodi Clinical Research Centre ( Site 1801), Bangkok

10408

National Cancer Center-Lung Cancer Center ( Site 1407), Goyang-si

10450

Hospital Pulau Pinang ( Site 1501), George Town

10700

Faculty of Medicine Siriraj Hospital ( Site 1800), Bangkok

11501

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022), Mineola

13620

Seoul National University Bundang Hospital ( Site 1403), Seongnam

14029

Chernihiv Medical Center of Modern Oncology-Clinical oncology and gynecology department ( Site 1113), Chernihiv

14050

Human Science Research Trials ( Site 0406), Mexico City

15001

Hospital Guillermo Almenara Irigoyen-Oncology ( Site 0508), Lima

15024

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0507), San Isidro

15036

Clínica Internacional - Sede San Borja ( Site 0506), Lima

15038

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0500), Lima

15076

Hospital Militar Central Luis Arias Schereiber ( Site 0502), Lima

16247

The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1405), Suwon

18009

Cherkasy Regional Oncology Dispensary ( Site 1110), Cherkassy

19111

Fox Chase Cancer Center-Hematology/Oncology ( Site 0030), Philadelphia

21029

Vinnytsia Regional Clinical Oncological Hospital ( Site 1102), Vinnytsia

25100

Hospital Tengku Ampuan Afzan ( Site 1502), Kuantan

28644

Chungbuk National University Hospital-Internal medicine ( Site 1406), Cheongju-si

31217

Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 0402), Chihuahua City

33486

Boca Raton Regional Hospital ( Site 0004), Boca Raton

34457

Acıbadem Maslak Hastanesi ( Site 1008), Istanbul

34668

Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1000), Istanbul

38039

Erciyes University Medical Oncology Department ( Site 1007), Talas

44680

Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0411), Guadalajara

49102

Municipal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council ( Site 1100), Dnipro

50048

MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 1104), Kryvyi Rih

55200

Samsun Medical Park Hastanesi-medical oncology ( Site 1005), Samsun

58260

Centro de Investigacion Clinica Chapultepec ( Site 0400), Morelia

59100

University Malaya Medical Centre ( Site 1504), Lembah Pantai

61103

Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1119), Kharkiv

61615

Illinois Cancer Care ( Site 0026), Peoria

62250

National Cancer Institute ( Site 1505), Putrajaya

63141

Mercy Research - David C. Pratt Cancer Center ( Site 0025), St Louis

64710

iCan Oncology Center Centro Medico AVE ( Site 0405), Monterrey

65804

Mercy Research - Cancer and Hematology Center ( Site 0032), Springfield

68000

Oaxaca Site Management Organization ( Site 0403), Oaxaca City

69059

Oncolife LLC-day-stay department ( Site 1107), Zaporizhzhia

76000

Hospital H+ Queretaro ( Site 0416), Querétaro City

76018

Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio, Ivano-Frankivsk

88000

Uzhgorod Central City Clinical Hospital-City oncology center ( Site 1120), Uzhhorod

97070

Medical Care and Research SA de CV ( Site 0409), Mérida

100000

Hanoi Oncology Hospital ( Site 2502), Hanoi

K Hospital - National Cancer Hospital ( Site 2506), Hanoi

National Lung Hospital-Oncology Department ( Site 2503), Hanoi

100010

SC Medical Center Gral SRL ( Site 2203), Ploieşti

100021

Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 2030), Beijing

100142

Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2001), Beijing

Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2003), Beijing

100730

Beijing Peking Union Medical College Hospital-pneumology department ( Site 2009), Beijing

101149

Beijing Chest Hospital,Capital Medical University ( Site 2020), Beijing

110029

All India Institute of Medical Sciences ( Site 2403), New Delhi

110085

Rajiv Gandhi Cancer Institute And Research Centre ( Site 2400), New Delhi

121205

Hadassah Medical-Oncology department ( Site 0814), Moscow

121359

Central Clinical Hospital of the Presidential Administrative Department ( Site 0802), Moscow

122001

Artemis hospital ( Site 2401), Gurugram

132000

Jilin Cancer Hospital-oncology department ( Site 2000), Changchun

143900

Moscow Regional Oncological Dispensary ( Site 0812), Balashikha

150081

Harbin Medical University Cancer Hospital ( Site 2006), Harbin

194291

GBUZ LOKB-Oncology department #1 ( Site 0804), Saint Petersburg

197758

Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 0803), Saint Petersburg

200032

Fudan University Shanghai Cancer Center ( Site 2032), Shanghai

200347

"Centrul de Oncologie Sfântul Nectarie-Medical Oncology ( Site 2202)", Craiova

225001

Northern Jiangsu People's Hospital-General Surgery Department ( Site 2016), Yangzhou

230000

The First Affiliated Hospital of Anhui Medical University ( Site 2022), Hefei

230036

Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2017), Hefei

276001

LinYi Cancer Hospital ( Site 2034), Linyi

310002

Hangzhou Cancer Hospital-Medical Oncology ( Site 2039), Hangzhou

310022

Zhejiang Cancer Hospital-Breast Oncology ( Site 2008), Hangzhou

310052

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

317000

Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2027), Linhai

325015

The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2031), Wenzhou

350014

Fujian Provincial Cancer Hospital-oncology department ( Site 2023), Fuzhou

350025

Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 2029), Fuzhou

400012

Tata Memorial Hospital-Medical Oncology ( Site 2404), Mumbai

400015

Cardiomed SRL Cluj-Napoca ( Site 2201), Cluj-Napoca

400030

Chongqing Cancer Hospital-Medical Oncology ( Site 2028), Chongqing

400042

Army Medical Center of People's Liberation Army-respiratory ( Site 2025), Chongqing

410008

Xiangya Hospital Central South University-Respiratory -Asthma&COPD ( Site 2026), Changsha

410013

Hunan Cancer Hospital-thoracic oncology II ( Site 2013), Changsha

420029

Republican Clinical Oncology Dispensary ( Site 0805), Kazan'

430010

Wuhan Union Hospital-Medical Oncology ( Site 2019), Wuhan

450008

Henan Cancer Hospital ( Site 2015), Zhengzhou

510515

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

603081

Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0809), Nizhny Novgorod

610041

West China Hospital Sichuan University-respiratory ( Site 2018), Chengdu

700000

HCMC University Medical Center-Chemotherapy Department ( Site 2501), Ho Chi Minh City

710038

Tang Du Hospital ( Site 2004), Xi'an

710061

The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2012), Xi'an

999007

Princess Margaret Hospital ( Site 1304), Lai Chi Kok

1240000

Bradford Hill Norte ( Site 0708), Antofagasta

1720430

IC La Serena Research ( Site 0710), La Serena

3465584

Clinica Universidad Catolica del Maule-Oncology ( Site 0703), Talca

4800827

James Lind Centro de Investigacion del Cancer ( Site 0711), Temuco

4810218

CIDO SpA-Oncology ( Site 0707), Temuco

5112129

Oncocentro Valdivia ( Site 0715), Valdivia

5500243

Clínica Puerto Montt ( Site 0713), Port Montt

7500653

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0712), Santiago

7500713

Orlandi Oncologia ( Site 0700), Santiago

7500921

FALP ( Site 0702), Santiago

8420383

Bradfordhill ( Site 0701), Santiago

60135-237

Hospital São Carlos-Oncocentro Ce ( Site 0208), Fortaleza

59075-740

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0201), Natal

98700-000

ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206), Ijuí

90050-170

Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa Novos Tratamentos em Cân, Porto Alegre

88020-210

CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0209), Florianópolis

20231-050

Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0204), Rio de Janeiro

01246-000

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0200), São Paulo

04014-002

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0207), São Paulo

V8R 6V5

BC Cancer Victoria-Clinical Trials Unit ( Site 0107), Victoria

L8V 5C2

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104), Hamilton

K7L 2V7

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0102), Kingston

L1G 2B9

Lakeridge Health ( Site 0106), Oshawa

H7M 3L9

Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava, Laval

Unknown

Linyi People's Hospital-Oncology ( Site 2035), Linyi

Queen Mary Hospital ( Site 1303), Hksar

Hong Kong United Oncology Centre ( Site 1302), Jordan

01010

CELAN,S.A ( Site 0304), Guatemala City

Gastrosoluciones ( Site 0302), Guatemala City

INTEGRA Cancer Institute ( Site 0303), Guatemala City

Onco Go, S.A ( Site 0306), Guatemala City

Oncomedica-Guatemala ( Site 0301), Guatemala City

01015

Grupo Medico Angeles ( Site 3007), Guatemala City

0000

Hong Kong Integrated Oncology Centre ( Site 1301), Central

460-0001

National Hospital Organization Nagoya Medical Center ( Site 1920), Nagoya

470-1192

Fujita Health University ( Site 1906), Toyoake

791-0295

Ehime University Hospital ( Site 1911), Tōon

830-0011

Kurume University Hospital ( Site 1912), Kurume

373-8550

Gunma Prefectural Cancer Center ( Site 1925), Otashi

003-0804

National Hospital Organization Hokkaido Cancer Center ( Site 1923), Sapporo

663-8501

Hyogo College of Medicine-Respiratory Medicine and Hematology ( Site 1922), Nishinomiya

665-0827

Takarazuka City Hospital ( Site 1924), Takarazuka

236-0051

Kanagawa Cardiovascular and Respiratory Center ( Site 1921), Yokohama

241-8515

Kanagawa cancer center ( Site 1916), Yokohama

981-0914

Sendai Kousei Hospital ( Site 1900), Sendai

951-8566

Niigata Cancer Center Hospital ( Site 1904), Niigata

573-1191

Kansai Medical University Hospital ( Site 1914), Hirakata

589-8511

Kindai University Hospital- Osakasayama Campus ( Site 1907), Ōsaka-sayama

591-8555

National Hospital Organization Kinki-chuo Chest Medical Center-Department of Thoracic Oncology ( Sit, Sakai

569-8686

Osaka Medical and Pharmaceutical University Hospital ( Site 1908), Takatsuki

411-8777

Shizuoka Cancer Center ( Site 1905), Nakatogari

320-0834

Tochigi Cancer Center ( Site 1927), Utsunomiya

260-8677

Chiba University Hospital-Medical Oncology ( Site 1926), Chiba

700-8558

Okayama University Hospital ( Site 1913), Okayama

541-8567

Osaka International Cancer Institute ( Site 1915), Osaka

770-8503

Tokushima University Hospital ( Site 1917), Tokushima

113-8431

Juntendo University Hospital ( Site 1902), Tokyo

135-8550

Japanese Foundation for Cancer Research ( Site 1901), Tokyo

641-8510

Wakayama Medical University Hospital ( Site 1910), Wakayama

06700

Arké SMO S.A. de C.V. ( Site 0417), Mexico City

CUSCO 84

UNIDAD DE ONCOLOGIA HOSPITAL NACIONAL ADOLFO GUEVARA VELASCO ESSSALUD CUSCO ( Site 0504), Cusco

0181

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0901), Pretoria

03080

Seoul National University Hospital ( Site 1401), Seoul

03181

Kangbuk Samsung Hospital ( Site 1409), Seoul

03312

The Catholic University of Korea, Eunpyeong St. Mary's Hospital-Cancer center ( Site 1410), Seoul

03722

Severance Hospital, Yonsei University Health System ( Site 1402), Seoul

05505

Asan Medical Center ( Site 1400), Seoul

06591

The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1408), Seoul

06230

Hacettepe Universitesi-oncology hospital ( Site 1001), Ankara

06520

Memorial Ankara Hastanesi-Medical Oncology ( Site 1002), Ankara

06560

Gazi Universitesi-Oncology ( Site 1003), Ankara

03022

National Cancer Institute ( Site 1114), Kyiv

700 000

Ho Chi Minh City Oncology Hospital - Tan Phu Ward ( Site 2505), Ho Chi Minh City

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY