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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)
Sponsor: Merck Sharp & Dohme LLC
Summary
The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.
Official title: A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
739
Start Date
2022-03-24
Completion Date
2026-01-09
Last Updated
2026-09-11
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab/Vibostolimab
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations
Carboplatin
Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations
Cisplatin
Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations
Paclitaxel
Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations
Nab-paclitaxel
Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations
Pemetrexed
Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision
Pembrolizumab
Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations
Locations (149)
UCHealth Memorial Hospital-Heme Onc ( Site 0003)
Colorado Springs, Colorado, United States
University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)
Fort Collins, Colorado, United States
Mayo Clinic in Florida ( Site 0022)
Jacksonville, Florida, United States
Mount Sinai Hospital ( Site 0011)
Chicago, Illinois, United States
University of Chicago Medical Center ( Site 0015)
Chicago, Illinois, United States
New England Cancer Specialists ( Site 0008)
Scarborough, Maine, United States
Cancer and Hematology Centers of Western Michigan ( Site 0002)
Grand Rapids, Michigan, United States
Mayo Clinic in Rochester, Minnesota ( Site 0030)
Rochester, Minnesota, United States
Stony Brook University-Cancer Center ( Site 0013)
Stony Brook, New York, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)
Lancaster, Pennsylvania, United States
Charleston Oncology ( Site 0019)
Charleston, South Carolina, United States
University of Virginia Cancer Center ( Site 0018)
Charlottesville, Virginia, United States
Centro de Oncología e Investigación de Buenos Aires ( Site 0203)
Berazategui, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204)
Mar del Plata, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)
ABB, Buenos Aires F.D., Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)
Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Parque ( Site 0205)
Rosario, Santa Fe Province, Argentina
Hospital Provincial del Centenario ( Site 0212)
Rosario, Santa Fe Province, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)
La Rioja, Argentina
Klinik Penzing-2. Lungenabteilung ( Site 0702)
Vienna, State of Vienna, Austria
Medizinische Universität Graz ( Site 0704)
Graz, Styria, Austria
Medizinische Universitaet Innsbruck ( Site 0703)
Innsbruck, Tyrol, Austria
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)
Linz, Upper Austria, Austria
Kepler Universitätsklinikum ( Site 0707)
Linz, Upper Austria, Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701)
Vienna, Austria
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403)
Natal, Rio Grande do Norte, Brazil
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405)
Porto Alegre, Rio Grande do Sul, Brazil
Clínica de Oncologia Reichow ( Site 0407)
Blumenau, Santa Catarina, Brazil
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)
Rio de Janeiro, Brazil
Hospital Paulistano ( Site 0401)
São Paulo, Brazil
James Lind Centro de Investigación del Cáncer ( Site 0502)
Temuco, Araucania, Chile
CIDO SpA-Oncology ( Site 0508)
Temuco, Araucania, Chile
Biocenter ( Site 0514)
Concepción, Biobio, Chile
FALP-UIDO ( Site 0505)
Santiago, Region M. de Santiago, Chile
Centro de Oncología de Precisión ( Site 0515)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0510)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 0503)
Viña del Mar, Valparaiso, Chile
Centro de Investigación Oncológica del Norte ( Site 0504)
Antofagasta, Chile
Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619)
Hefei, Anhui, China
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602)
Beijing, Beijing Municipality, China
Fujian Provincial Cancer Hospital-oncology department ( Site 2621)
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University ( Site 2626)
Xiamen, Fujian, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital-oncology of department ( Site 2604)
Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 2608)
Zhengzhou, Henan, China
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618)
Wuhan, Hubei, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 2617)
Wuhan, Hubei, China
Xiangya Hospital Central South University-Oncology department ( Site 2627)
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University ( Site 2623)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 2622)
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625)
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624)
Nanchang, Jiangxi, China
Jilin Cancer Hospital-oncology department ( Site 2603)
Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607)
Xi'an, Shaanxi, China
Shandong Cancer Hospital-Oncology Department ( Site 2630)
Jinan, Shandong, China
Fudan University Shanghai Cancer Center ( Site 2616)
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)
Shanghai, Shanghai Municipality, China
Sichuan Cancer hospital ( Site 2628)
Chengdu, Sichuan, China
West China Hospital of Sichuan University ( Site 2610)
Chengdu, Sichuan, China
The Second People's Hospital of Yibin ( Site 2629)
Yibin, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606)
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613)
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital-Oncology ( Site 2612)
Hangzhou, Zhejiang, China
The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
Hangzhou, Zhejiang, China
Fundación Colombiana de Cancerología Clínica Vida ( Site 0603)
Medellín, Antioquia, Colombia
Administradora Country S.A. - Clinica del Country ( Site 0601)
Bogotá, Bogota D.C., Colombia
Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)
Valledupar, Cesar Department, Colombia
Oncomedica S.A.-Oncomedica S.A ( Site 0609)
Montería, Departamento de Córdoba, Colombia
Oncologos del Occidente ( Site 0608)
Pereira, Risaralda Department, Colombia
CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806)
Orléans, Centre-Val de Loire, France
Centre Hospitalier d'Annecy ( Site 0807)
Epagny Metz-Tessy, Haute-Savoie, France
Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th
Lille, Hauts-de-France, France
Institut de Cancérologie de l'Ouest ( Site 0802)
Angers, Maine-et-Loire, France
CENTRE LEON BERARD ( Site 0803)
Lyon, Rhone, France
HIA Sainte Anne ( Site 0804)
Toulon, Var, France
Centre Hospitalier d'Avignon ( Site 0810)
Avignon, Vaucluse, France
UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)
Giessen, Hesse, Germany
GEFOS Gesellschaft f. onkologische Studien ( Site 0909)
Dortmund, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)
Lübeck, Schleswig-Holstein, Germany
SRH Wald-Klinikum Gera ( Site 0911)
Gera, Thuringia, Germany
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913
Berlin, Germany
Rambam Health Care Campus-Oncology ( Site 1303)
Haifa, Israel
Shaare Zedek Medical Center-Oncology ( Site 1306)
Jerusalem, Israel
Meir Medical Center-oncology ( Site 1301)
Kfar Saba, Israel
Sheba Medical Center-ONCOLOGY ( Site 1302)
Ramat Gan, Israel
Sourasky Medical Center-Oncology ( Site 1305)
Tel Aviv, Israel
National Hospital Organization Shikoku Cancer Center ( Site 2414)
Matsuyama, Ehime, Japan
Ehime University Hospital ( Site 2411)
Tōon, Ehime, Japan
Hyogo Cancer Center-Thoracic Oncology ( Site 2409)
Akashi, Hyōgo, Japan
Kanazawa University Hospital ( Site 2407)
Kanazawa, Ishikawa-ken, Japan
Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405)
Yokohama, Kanagawa, Japan
Miyagi Cancer Center ( Site 2401)
Natori-shi, Miyagi, Japan
Kansai Medical University Hospital ( Site 2415)
Hirakata, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 2406)
Ina-machi, Saitama, Japan
Shizuoka Cancer Center ( Site 2408)
Nakatogari, Shizuoka, Japan
Japanese Foundation for Cancer Research ( Site 2402)
Koto, Tokyo, Japan
Showa University Hospital ( Site 2403)
Shinagawa, Tokyo, Japan
National Hospital Organization Kyushu Medical Center ( Site 2413)
Fukuoka, Japan