Lung Cancer Clinical Trial

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)

Summary

The primary hypotheses are that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

View Eligibility Criteria

Eligibility Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC.
Has not received prior systemic treatment for metastatic NSCLC.
Has measurable disease based on RECIST 1.1, as determined by the local site assessment.
Has a life expectancy of at least 3 months.
Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method.

Exclusion Criteria:

Known additional malignancy that is progressing or has required active treatment within the past 3 years.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Severe hypersensitivity to vibostolimab, pembrolizumab, chemotherapy components, and/or any of its excipients.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus.
Received prior systemic anticancer therapy for metastatic disease.
Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
History of allogeneic tissue/solid organ transplant.
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
Is unable or unwilling to take folic acid or vitamin B12 supplementation.
Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

700

Study ID:

NCT05226598

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 142 Locations for this study

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UCHealth Memorial Hospital-Heme Onc ( Site 0003)
Colorado Springs Colorado, 80909, United States
University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)
Fort Collins Colorado, 80528, United States
Mayo Clinic in Florida ( Site 0022)
Jacksonville Florida, 32224, United States
Mount Sinai Hospital ( Site 0011)
Chicago Illinois, 60608, United States
University of Chicago Medical Center ( Site 0015)
Chicago Illinois, 60637, United States
New England Cancer Specialists ( Site 0008)
Scarborough Maine, 04074, United States
Cancer and Hematology Centers of Western Michigan ( Site 0002)
Grand Rapids Michigan, 49503, United States
Mayo Clinic in Rochester, Minnesota ( Site 0030)
Rochester Minnesota, 55905, United States
Stony Brook University-Cancer Center ( Site 0013)
Stony Brook New York, 11794, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)
Lancaster Pennsylvania, 17604, United States
Charleston Oncology ( Site 0019)
Charleston South Carolina, 29414, United States
University of Virginia Cancer Center ( Site 0018)
Charlottesville Virginia, 22903, United States
Centro de Oncología e Investigación de Buenos Aires ( Site 0203)
Berazategui Buenos Aires, B1884, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204)
Mar del Plata Buenos Aires, B7600, Argentina
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)
ABB Caba, C1199, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)
Buenos Aires Caba, C1431, Argentina
Sanatorio Parque ( Site 0205)
Rosario Santa Fe, 2000, Argentina
Hospital Provincial del Centenario ( Site 0212)
Rosario Santa Fe, 2002, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)
La Rioja , F5300, Argentina
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)
Linz Oberosterreich, 4020, Austria
Kepler Universitätsklinikum ( Site 0707)
Linz Oberosterreich, 4021, Austria
Medizinische Universität Graz ( Site 0704)
Graz Steiermark, 8036, Austria
Medizinische Universitaet Innsbruck ( Site 0703)
Innsbruck Tirol, 6020, Austria
Klinik Penzing-2. Lungenabteilung ( Site 0702)
Vienna Wien, 1140, Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701)
Wien , 1210, Austria
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403)
Natal Rio Grande Do Norte, 59075, Brazil
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405)
Porto Alegre Rio Grande Do Sul, 91350, Brazil
Clínica de Oncologia Reichow ( Site 0407)
Blumenau Santa Catarina, 89010, Brazil
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)
Rio de Janeiro , 20230, Brazil
Hospital Paulistano ( Site 0401)
Sao Paulo , 01321, Brazil
James Lind Centro de Investigación del Cáncer ( Site 0502)
Temuco Araucania, 48008, Chile
CIDO SpA-Oncology ( Site 0508)
Temuco Araucania, 48101, Chile
Biocenter ( Site 0514)
Concepción Biobio, 40701, Chile
FALP-UIDO ( Site 0505)
Santiago Region M. De Santiago, 69009, Chile
Centro de Oncología de Precisión ( Site 0515)
Santiago Region M. De Santiago, 75609, Chile
Bradfordhill ( Site 0510)
Santiago Region M. De Santiago, 84203, Chile
ONCOCENTRO APYS-ACEREY ( Site 0503)
Viña del Mar Valparaiso, 25205, Chile
Centro de Investigación Oncológica del Norte ( Site 0504)
Antofagasta , 12400, Chile
Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619)
Hefei Anhui, 23003, China
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602)
Beijing Beijing, 10014, China
Fujian Provincial Cancer Hospital-oncology department ( Site 2621)
Fuzhou Fujian, 35001, China
The First Affiliated hospital of Xiamen University ( Site 2626)
Xiamen City Fujian, 36100, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
Guangzhou Guangdong, 51051, China
Harbin Medical University Cancer Hospital-oncology of department ( Site 2604)
Harbin Heilongjiang, 15000, China
Henan Cancer Hospital ( Site 2608)
Zhengzhou Henan, 45000, China
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618)
Wuhan Hubei, 43002, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 2617)
Wuhan Hubei, 43003, China
Xiangya Hospital Central South University-Oncology department ( Site 2627)
Changsha Hunan, 41000, China
The Second Xiangya Hospital of Central South University ( Site 2623)
Changsha Hunan, 41001, China
Hunan Cancer Hospital ( Site 2622)
Changsha Hunan, 41001, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
Nanjing Jiangsu, 21000, China
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625)
Nanchang Jiangxi, 33000, China
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624)
Nanchang Jiangxi, 33000, China
Jilin Cancer Hospital-oncology department ( Site 2603)
Changchun Jilin, 13200, China
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607)
Xi'an Shaanxi, 71006, China
Shandong Cancer Hospital-Oncology Department ( Site 2630)
Jinan Shandong, 25011, China
Fudan University Shanghai Cancer Center ( Site 2616)
Shanghai Shanghai, 20003, China
Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)
Shanghai Shanghai, 20043, China
West China Hospital of Sichuan University ( Site 2610)
Cheng Du Sichuan, 61004, China
Sichuan Cancer hospital ( Site 2628)
Chengdu Sichuan, 61004, China
The Second People's Hospital of Yibin ( Site 2629)
Yibin Sichuan, 64400, China
Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606)
Tianjin Tianjin, 30006, China
The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613)
Hangzhou Zhejiang, 31000, China
Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615)
Hangzhou Zhejiang, 31001, China
Zhejiang Cancer Hospital-Oncology ( Site 2612)
Hangzhou Zhejiang, 31002, China
The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
Hangzhou Zhejiang, 31005, China
Fundación Colombiana de Cancerología Clínica Vida ( Site 0603)
Medellin Antioquia, 05003, Colombia
Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)
Valledupar Cesar, 20000, Colombia
Oncomedica S.A.-Oncomedica S.A ( Site 0609)
Montería Cordoba, 23000, Colombia
Administradora Country S.A. - Clinica del Country ( Site 0601)
Bogotá Distrito Capital De Bogota, 11022, Colombia
Oncologos del Occidente ( Site 0608)
Pereira Risaralda, 66000, Colombia
CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806)
Orléans Centre, 45067, France
Centre Hospitalier d'Annecy ( Site 0807)
Epagny Metz-Tessy Haute-Savoie, 74370, France
Institut de Cancérologie de l'Ouest ( Site 0802)
ANGERS cedex 02 Maine-et-Loire, 49055, France
Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th
Lille Nord-Pas-de-Calais, 59037, France
CENTRE LEON BERARD ( Site 0803)
Lyon CEDEX 08 Rhone, 69373, France
HIA Sainte Anne ( Site 0804)
Toulon Var, 83800, France
Centre Hospitalier d'Avignon ( Site 0810)
Avignon Vaucluse, 84000, France
UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)
Gießen Hessen, 35392, Germany
GEFOS Gesellschaft f. onkologische Studien ( Site 0909)
Dortmund Nordrhein-Westfalen, 44263, Germany
Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)
Lübeck Schleswig-Holstein, 23538, Germany
SRH Wald-Klinikum Gera ( Site 0911)
Gera Thuringen, 07548, Germany
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913
Berlin , 13353, Germany
Rambam Health Care Campus-Oncology ( Site 1303)
Haifa , 31096, Israel
Shaare Zedek Medical Center-Oncology ( Site 1306)
Jerusalem , 90131, Israel
Meir Medical Center-oncology ( Site 1301)
Kfar Saba , 44281, Israel
Sheba Medical Center-ONCOLOGY ( Site 1302)
Ramat Gan , 52656, Israel
Sourasky Medical Center-Oncology ( Site 1305)
Tel Aviv , 64239, Israel
National Hospital Organization Shikoku Cancer Center ( Site 2414)
Matsuyama Ehime, 791-0, Japan
Ehime University Hospital ( Site 2411)
Toon Ehime, 791-0, Japan
Hyogo Cancer Center-Thoracic Oncology ( Site 2409)
Akashi Hyogo, 673-8, Japan
Kanazawa University Hospital ( Site 2407)
Kanazawa Ishikawa, 920-8, Japan
Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405)
Yokohama Kanagawa, 241-8, Japan
Miyagi Cancer Center ( Site 2401)
Natori Miyagi, 981-1, Japan
Kansai Medical University Hospital ( Site 2415)
Hirakata Osaka, 573-1, Japan
Saitama Prefectural Cancer Center ( Site 2406)
Ina-machi Saitama, 362-0, Japan
Shizuoka Cancer Center ( Site 2408)
Nagaizumi Shizuoka, 411-8, Japan
Japanese Foundation for Cancer Research ( Site 2402)
Koto Tokyo, 135-8, Japan
Showa University Hospital ( Site 2403)
Shinagawa Tokyo, 14286, Japan
National Hospital Organization Kyushu Medical Center ( Site 2413)
Fukuoka , 810-8, Japan
National Hospital Organization Kyushu Cancer Center ( Site 2412)
Fukuoka , 811-1, Japan
Okayama University Hospital ( Site 2410)
Okayama , 700-8, Japan
Nippon Medical School Hospital ( Site 2404)
Tokyo , 113-8, Japan
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201)
Hwasun Jeonranamdo, 58128, Korea, Republic of
Pusan National University Hospital ( Site 2205)
Busan Pusan-Kwangyokshi, 49241, Korea, Republic of
Asan Medical Center ( Site 2206)
Songpa-gu Seoul, 05505, Korea, Republic of
Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)
Deagu Taegu-Kwangyokshi, 41404, Korea, Republic of
Chungnam national university hospital-Department of Internal Medicine ( Site 2203)
Daejeon Taejon-Kwangyokshi, 35015, Korea, Republic of
Korea University Guro Hospital-Internal Medicine ( Site 2204)
Seoul , , Korea, Republic of
CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304)
Saltillo Coahuila, 25279, Mexico
Alivia Clínica de Alta Especialidad ( Site 0310)
Ciudad de Mexico Distrito Federal, 06760, Mexico
Arké SMO S.A. de C.V. ( Site 0301)
Mexico Distrito Federal, 06700, Mexico
Hospital Civil Fray Antonio Alcalde ( Site 0307)
Guadalajara Jalisco, 44280, Mexico
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903)
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)
Warsaw Mazowieckie, 04-12, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
Warszawa Mazowieckie, 02-78, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904)
Przemysl Podkarpackie, 37-70, Poland
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906)
Prabuty Pomorskie, 82-55, Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)
Bystra Slaskie, 43-36, Poland
Przychodnia Lekarska KOMED ( Site 1902)
Konin Wielkopolskie, 62-50, Poland
Med-Polonia Sp. z o. o. ( Site 1909)
Poznan Wielkopolskie, 60-69, Poland
CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106)
A Coruña La Coruna, 15006, Spain
Hospital Insular de Gran Canaria-Oncology ( Site 1102)
Las Palmas de Gran Canaria Las Palmas, 35001, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)
Barcelona , 08035, Spain
Hospital Clinico San Carlos-Oncology Department ( Site 1107)
Madrid , 28040, Spain
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103)
Sevilla , 41009, Spain
Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105)
Zaragoza , 50009, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254)
Kaohsiung , 807, Taiwan
China Medical University Hospital ( Site 2253)
Taichung , 40447, Taiwan
NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252)
Tainan , 704, Taiwan
National Taiwan University Hospital-Oncology ( Site 2255)
Taipei , 100, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 2251)
Taoyuan , 333, Taiwan
Faculty of Medicine - Khon Kaen University ( Site 2303)
Muang Khon Kaen, 40002, Thailand
Faculty of Medicine Siriraj Hospital ( Site 2304)
Bangkok Krung Thep Maha Nakhon, 10700, Thailand
Chulabhorn Hospital ( Site 2305)
Lak Si Krung Thep Maha Nakhon, 10210, Thailand
Songklanagarind hospital ( Site 2302)
Hatyai Songkhla, 90110, Thailand
Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301)
Chiang Mai , 50200, Thailand
Acibadem Altunizade Hospital-Oncology ( Site 1207)
Üsküdar / Stanbul Istanbul, 34662, Turkey
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208)
Adana , 01250, Turkey
Hacettepe Universitesi-oncology hospital ( Site 1202)
Ankara , 06230, Turkey
Liv Hospital Ankara-Oncology ( Site 1205)
Ankara , 06680, Turkey
Ankara City Hospital ( Site 1204)
Ankara , 06800, Turkey
Trakya University-Medical Oncology ( Site 1203)
Edirne , 22030, Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209)
Istanbul , 34722, Turkey
Umraniye Training and Research Hospital-medical oncology ( Site 1206)
Istanbul , 34766, Turkey
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)
Leicester England, , United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501)
London England, SW10 , United Kingdom
University College London Hospital-Cancer Clinical Trials Unit ( Site 1509)
London-Camden London, City Of, NW1 2, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506)
London London, City Of, EC1A , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

700

Study ID:

NCT05226598

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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