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 allogenic 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:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 116 Locations for this study

See Locations Near You

UCHealth Memorial Hospital-Heme Onc ( Site 0003)
Colorado Springs Colorado, 80909, United States More Info
Study Coordinator
Contact
719-365-2406
University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)
Fort Collins Colorado, 80528, United States More Info
Study Coordinator
Contact
970-297-6150
Mount Sinai Hospital ( Site 0011)
Chicago Illinois, 60608, United States More Info
Study Coordinator
Contact
772-257-6120
New England Cancer Specialists ( Site 0008)
Scarborough Maine, 04074, United States More Info
Study Coordinator
Contact
207-303-3300
Cancer and Hematology Centers of Western Michigan ( Site 0002)
Grand Rapids Michigan, 49503, United States More Info
Study Coordinator
Contact
616-954-9800
Stony Brook University-Cancer Center ( Site 0013)
Stony Brook New York, 11794, United States More Info
Study Coordinator
Contact
631-444-2296
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)
Lancaster Pennsylvania, 17604, United States More Info
Study Coordinator
Contact
717-544-9400
Charleston Oncology ( Site 0019)
Charleston South Carolina, 29414, United States More Info
Study Coordinator
Contact
8435776957x291
University of Virginia Cancer Center ( Site 0018)
Charlottesville Virginia, 22903, United States More Info
Study Coordinator
Contact
434-243-6303
Centro de Oncología e Investigación de Buenos Aires ( Site 0203)
Berazategui Buenos Aires, B1884, Argentina More Info
Study Coordinator
Contact
541142262013
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204)
Mar del Plata Buenos Aires, 7600, Argentina More Info
Study Coordinator
Contact
542234963224
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)
ABB Caba, C1199, Argentina More Info
Study Coordinator
Contact
+541149590200
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)
Buenos Aires Caba, C1431, Argentina More Info
Study Coordinator
Contact
541144031470
Sanatorio Parque ( Site 0205)
Rosario Santa Fe, 2000, Argentina More Info
Study Coordinator
Contact
54 0341 4200250
Hospital Provincial del Centenario ( Site 0212)
Rosario Santa Fe, 2002, Argentina More Info
Study Coordinator
Contact
543414724649
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)
La Rioja , F5300, Argentina More Info
Study Coordinator
Contact
543804425438
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)
Linz Oberosterreich, 4020, Austria More Info
Study Coordinator
Contact
+4373276763220
Kepler Universitätsklinikum ( Site 0707)
Linz Oberosterreich, 4021, Austria More Info
Study Coordinator
Contact
+4357680836911
Medizinische Universität Graz ( Site 0704)
Graz Steiermark, 8036, Austria More Info
Study Coordinator
Contact
004331638512183
Medizinische Universitaet Innsbruck ( Site 0703)
Innsbruck Tirol, 6020, Austria More Info
Study Coordinator
Contact
+4350125040
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403)
Natal Rio Grande Do Norte, 59075, Brazil More Info
Study Coordinator
Contact
+558440095595
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405)
Porto Alegre Rio Grande Do Sul, 91350, Brazil More Info
Study Coordinator
Contact
+5551993590437
Clínica de Oncologia Reichow ( Site 0407)
Blumenau Santa Catarina, 89010, Brazil More Info
Study Coordinator
Contact
554733805858
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)
Rio de Janeiro , 20230, Brazil More Info
Study Coordinator
Contact
+552132076569
Hospital Paulistano ( Site 0401)
Sao Paulo , 01321, Brazil More Info
Study Coordinator
Contact
+551131411083
James Lind Centro de Investigación del Cáncer ( Site 0502)
Temuco Araucania, 48008, Chile More Info
Study Coordinator
Contact
56452982404
CIDO SpA-Oncology ( Site 0508)
Temuco Araucania, 48101, Chile More Info
Study Coordinator
Contact
569 5 798 31 73
Biocenter ( Site 0514)
Concepción Biobio, 40701, Chile More Info
Study Coordinator
Contact
+56974779078
FALP-UIDO ( Site 0505)
Santiago Region M. De Santiago, 69009, Chile More Info
Study Coordinator
Contact
56224457254
Centro de Oncología de Precisión ( Site 0515)
Santiago Region M. De Santiago, 75609, Chile More Info
Study Coordinator
Contact
56991612199
Bradfordhill ( Site 0510)
Santiago Region M. De Santiago, 84203, Chile More Info
Study Coordinator
Contact
+56998744662
ONCOCENTRO APYS-ACEREY ( Site 0503)
Viña del Mar Valparaiso, 25205, Chile More Info
Study Coordinator
Contact
56 9 9236 9820
Centro de Investigación Oncológica del Norte ( Site 0504)
Antofagasta , 12400, Chile More Info
Study Coordinator
Contact
+56994198125
Fujian Provincial Cancer Hospital-oncology department ( Site 2621)
Fuzhou Fujian, 35001, China More Info
Study Coordinator
Contact
138 0950 0871
The First Affiliated hospital of Xiamen University ( Site 2626)
Xiamen City Fujian, 36100, China More Info
Study Coordinator
Contact
138 6045 8889
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
Guangzhou Guangdong, 51051, China More Info
Study Coordinator
Contact
020-61641575
Henan Cancer Hospital ( Site 2608)
Zhengzhou Henan, 45000, China More Info
Study Coordinator
Contact
+8613938252350
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618)
Wuhan Hubei, 43002, China More Info
Study Coordinator
Contact
+86 027-85726300
Hunan Cancer Hospital ( Site 2622)
Changsha Hunan, 41001, China More Info
Study Coordinator
Contact
0731-88651669
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625)
Nanchang Jiangxi, 33000, China More Info
Study Coordinator
Contact
0791-88695125
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624)
Nanchang Jiangxi, 33000, China More Info
Study Coordinator
Contact
0791-86300985
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607)
Xi'an Shaanxi, 71006, China More Info
Study Coordinator
Contact
8613572101611
Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)
Shanghai Shanghai, 20043, China More Info
Study Coordinator
Contact
021-65115006-1207
West China Hospital of Sichuan University ( Site 2610)
Cheng Du Sichuan, 61004, China More Info
Study Coordinator
Contact
18980602258
Sichuan Cancer hospital ( Site 2628)
Chengdu Sichuan, 61004, China More Info
Study Coordinator
Contact
18908190269
The Second People's Hospital of Yibin ( Site 2629)
Yibin Sichuan, 64400, China More Info
Study Coordinator
Contact
13990903661
Zhejiang Cancer Hospital-Oncology ( Site 2612)
Hangzhou Zhejiang, 31002, China More Info
Study Coordinator
Contact
0571- 88122222
The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
Hangzhou Zhejiang, 31005, China More Info
Study Coordinator
Contact
0571-87783777
Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)
Valledupar Cesar, 20000, Colombia More Info
Study Coordinator
Contact
573128385292
Oncomedica S.A.-Oncomedica S.A ( Site 0609)
Montería Cordoba, 23000, Colombia More Info
Study Coordinator
Contact
+576047854344
Administradora Country S.A. - Clinica del Country ( Site 0601)
Bogotá Distrito Capital De Bogota, 11022, Colombia More Info
Study Coordinator
Contact
+573108627483
Oncologos del Occidente ( Site 0608)
Pereira Risaralda, 66000, Colombia More Info
Study Coordinator
Contact
573114746650
CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806)
Orléans Centre, 45067, France More Info
Study Coordinator
Contact
+33238514719
Centre Hospitalier d'Annecy ( Site 0807)
Epagny Metz-Tessy Haute-Savoie, 74370, France More Info
Study Coordinator
Contact
33450637133
Institut de Cancérologie de l'Ouest ( Site 0802)
ANGERS cedex 02 Maine-et-Loire, 49055, France More Info
Study Coordinator
Contact
+33244853754
Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th
Lille Nord-Pas-de-Calais, 59037, France More Info
Study Coordinator
Contact
33320444998
CENTRE LEON BERARD ( Site 0803)
Lyon CEDEX 08 Rhone, 69373, France More Info
Study Coordinator
Contact
33426556842
HIA Sainte Anne ( Site 0804)
Toulon Var, 83800, France More Info
Study Coordinator
Contact
0033483162937
Centre Hospitalier d'Avignon ( Site 0810)
Avignon Vaucluse, 84000, France More Info
Study Coordinator
Contact
0432759330
UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)
Gießen Hessen, 35392, Germany More Info
Study Coordinator
Contact
+49 (0)641 985 59253
GEFOS Gesellschaft f. onkologische Studien ( Site 0909)
Dortmund Nordrhein-Westfalen, 44263, Germany More Info
Study Coordinator
Contact
+49231 206-1692
Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)
Lübeck Schleswig-Holstein, 23538, Germany More Info
Study Coordinator
Contact
+49 451 500-45023
SRH Wald-Klinikum Gera ( Site 0911)
Gera Thuringen, 07548, Germany More Info
Study Coordinator
Contact
+49 3658282151
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913
Berlin , 13353, Germany More Info
Study Coordinator
Contact
004930450665005
Rambam Health Care Campus-Oncology ( Site 1303)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+972-4-7776412
Shaare Zedek Medical Center-Oncology ( Site 1306)
Jerusalem , 91031, Israel More Info
Study Coordinator
Contact
+97239377951
Meir Medical Center-oncology ( Site 1301)
Kfar Saba , 44281, Israel More Info
Study Coordinator
Contact
+97297472414
Sheba Medical Center-ONCOLOGY ( Site 1302)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
+97235307096
Sourasky Medical Center-Oncology ( Site 1305)
Tel Aviv , 64239, Israel More Info
Study Coordinator
Contact
+972 3-6972063
National Hospital Organization Shikoku Cancer Center ( Site 2414)
Matsuyama Ehime, 791-0, Japan More Info
Study Coordinator
Contact
+81-89-999-1111
Ehime University Hospital ( Site 2411)
Toon Ehime, 791-0, Japan More Info
Study Coordinator
Contact
+81-89-964-5111
Hyogo Cancer Center-Thoracic Oncology ( Site 2409)
Akashi Hyogo, 673-8, Japan More Info
Study Coordinator
Contact
+81-78-929-1151
Kanazawa University Hospital ( Site 2407)
Kanazawa Ishikawa, 920-8, Japan More Info
Study Coordinator
Contact
+81-76-265-2000
Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405)
Yokohama Kanagawa, 241-8, Japan More Info
Study Coordinator
Contact
+81-45-520-2222
Miyagi Cancer Center ( Site 2401)
Natori Miyagi, 981-1, Japan More Info
Study Coordinator
Contact
+81-22-384-3151
Kansai Medical University Hospital ( Site 2415)
Hirakata Osaka, 57211, Japan More Info
Study Coordinator
Contact
'+81-72-804-0101
Saitama Prefectural Cancer Center ( Site 2406)
Ina-machi Saitama, 362-0, Japan More Info
Study Coordinator
Contact
+81-48-722-1111
Shizuoka Cancer Center ( Site 2408)
Nagaizumi Shizuoka, 411-8, Japan More Info
Study Coordinator
Contact
+81-55-989-5222
Japanese Foundation for Cancer Research ( Site 2402)
Koto Tokyo, 135-8, Japan More Info
Study Coordinator
Contact
+81-3-3520-0111
Showa University Hospital ( Site 2403)
Shinagawa Tokyo, 14286, Japan More Info
Study Coordinator
Contact
+81-3-3784-8000
National Hospital Organization Kyushu Medical Center ( Site 2413)
Fukuoka , 810-8, Japan More Info
Study Coordinator
Contact
+81-92-852-0700
National Hospital Organization Kyushu Cancer Center ( Site 2412)
Fukuoka , 811-1, Japan More Info
Study Coordinator
Contact
+81-92-541-3231
Okayama University Hospital ( Site 2410)
Okayama , 700-8, Japan More Info
Study Coordinator
Contact
+81-86-223-7151
Nippon Medical School Hospital ( Site 2404)
Tokyo , 113-8, Japan More Info
Study Coordinator
Contact
+81-3-3822-2131
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201)
Hwasun Jeonranamdo, 58128, Korea, Republic of More Info
Study Coordinator
Contact
+82613797614
Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)
Deagu Taegu-Kwangyokshi, 41404, Korea, Republic of More Info
Study Coordinator
Contact
+82532002632
Chungnam national university hospital-Department of Internal Medicine ( Site 2203)
Daejeon Taejon-Kwangyokshi, 35015, Korea, Republic of More Info
Study Coordinator
Contact
+82422608584
Korea University Guro Hospital-Internal Medicine ( Site 2204)
Seoul , , Korea, Republic of More Info
Study Coordinator
Contact
+82226261914
CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304)
Saltillo Coahuila, 25279, Mexico More Info
Study Coordinator
Contact
+52 844 688-7477
Arké SMO S.A. de C.V. ( Site 0301)
Mexico Distrito Federal, 06700, Mexico More Info
Study Coordinator
Contact
+52 55 5511-5833
Hospital Civil Fray Antonio Alcalde ( Site 0307)
Guadalajara Jalisco, 44280, Mexico More Info
Study Coordinator
Contact
+52 +52 33 1606-3096
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903)
Bydgoszcz Kujawsko-pomorskie, 85796, Poland More Info
Study Coordinator
Contact
48501446778
Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)
Warsaw Mazowieckie, 04-12, Poland More Info
Study Coordinator
Contact
48796987644
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
Warszawa Mazowieckie, 02-78, Poland More Info
Study Coordinator
Contact
+48225463066
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904)
Przemysl Podkarpackie, 37-70, Poland More Info
Study Coordinator
Contact
4816 6775000
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906)
Prabuty Pomorskie, 82-55, Poland More Info
Study Coordinator
Contact
48503022396
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)
Bystra Slaskie, 43-36, Poland More Info
Study Coordinator
Contact
48334991801
Przychodnia Lekarska KOMED ( Site 1902)
Konin Wielkopolskie, 62-50, Poland More Info
Study Coordinator
Contact
48632428009
CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106)
A Coruña La Coruna, 15006, Spain More Info
Study Coordinator
Contact
+34981178000
Hospital Insular de Gran Canaria-Oncology ( Site 1102)
Las Palmas de Gran Canaria Las Palmas, 35001, Spain More Info
Study Coordinator
Contact
+34928441738
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)
Barcelona , 08035, Spain More Info
Study Coordinator
Contact
+34932746085
Hospital Clinico San Carlos-Oncology Department ( Site 1107)
Madrid , 28040, Spain More Info
Study Coordinator
Contact
+34913303000
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103)
Sevilla , 41009, Spain More Info
Study Coordinator
Contact
+34955926578
Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105)
Zaragoza , 50009, Spain More Info
Study Coordinator
Contact
+34 976 765769
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254)
Kaohsiung , 807, Taiwan More Info
Study Coordinator
Contact
+886-7-3121101 ext.5651
China Medical University Hospital ( Site 2253)
Taichung , 40447, Taiwan More Info
Study Coordinator
Contact
+886-4-22052121
NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252)
Tainan , 704, Taiwan More Info
Study Coordinator
Contact
06-2353535
National Taiwan University Hospital-Oncology ( Site 2255)
Taipei , 10002, Taiwan More Info
Study Coordinator
Contact
02-23123456
Chang Gung Medical Foundation-Linkou Branch ( Site 2251)
Taoyuan , 333, Taiwan More Info
Study Coordinator
Contact
03-3281200
Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301)
Chiang Mai , 50200, Thailand More Info
Study Coordinator
Contact
6653 9360 46-49
Acibadem Altunizade Hospital-Oncology ( Site 1207)
Üsküdar / Stanbul Istanbul, 34662, Turkey More Info
Study Coordinator
Contact
05421572862
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208)
Adana , 01250, Turkey More Info
Study Coordinator
Contact
05421572862
Hacettepe Universitesi-oncology hospital ( Site 1202)
Ankara , 06230, Turkey More Info
Study Coordinator
Contact
+903123053432
Liv Hospital Ankara-Oncology ( Site 1205)
Ankara , 06680, Turkey More Info
Study Coordinator
Contact
+903126664616
Ankara City Hospital ( Site 1204)
Ankara , 06800, Turkey More Info
Study Coordinator
Contact
+903125526000
Trakya University-Medical Oncology ( Site 1203)
Edirne , 22030, Turkey More Info
Study Coordinator
Contact
05421572862
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209)
Istanbul , 34722, Turkey More Info
Study Coordinator
Contact
05421572862
Umraniye Training and Research Hospital-medical oncology ( Site 1206)
Istanbul , 34766, Turkey More Info
Study Coordinator
Contact
05421572862
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)
Leicester England, , United Kingdom More Info
Study Coordinator
Contact
0116 258 6318
Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501)
London England, SW10 , United Kingdom More Info
Study Coordinator
Contact
0203 3158000
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506)
London London, City Of, EC1A , United Kingdom More Info
Study Coordinator
Contact
0207 3777 000
University College London Hospital-Cancer Clinical Trials Unit ( Site 1509)
London London, City Of, NW1 2, United Kingdom More Info
Study Coordinator
Contact
07852219920

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:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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