AzTrials
AzTrials

Metastatic Non-Small Cell Lung CancerPhase 3NCT05226598

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)

A Phase 3 study testing Pembrolizumab/Vibostolimab, Carboplatin and Cisplatin in people with Metastatic Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 149 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Non-Small Cell Lung Cancer
What is being tested?
Pembrolizumab/Vibostolimab, Carboplatin and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
739 participants
Where
149 sitesin 19 countries
Study dates
24 Mar 2022to 9 Jan 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 MK-7684, MK-7684A, 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, except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
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  • 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

Trial locations and contacts

149 sites in 19 countries.

149 sites in 19 countries

China28 sites

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

    Beijing, Beijing Municipality, 100142

  • Jilin Cancer Hospital-oncology department ( Site 2603)

    Changchun, Jilin, 132000

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

    Changsha, Hunan, 410008

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

    Changsha, Hunan, 410011

  • Hunan Cancer Hospital ( Site 2622)

    Changsha, Hunan, 410013

  • Sichuan Cancer hospital ( Site 2628)

    Chengdu, Sichuan, 610041

  • West China Hospital of Sichuan University ( Site 2610)

    Chengdu, Sichuan, 610041

  • Fujian Provincial Cancer Hospital-oncology department ( Site 2621)

    Fuzhou, Fujian, 350014

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

    Guangzhou, Guangdong, 510515

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

    Hangzhou, Zhejiang, 310003

  • Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615)

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital-Oncology ( Site 2612)

    Hangzhou, Zhejiang, 310022

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

    Hangzhou, Zhejiang, 310052

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

    Harbin, Heilongjiang, 150000

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

    Hefei, Anhui, 230036

  • Shandong Cancer Hospital-Oncology Department ( Site 2630)

    Jinan, Shandong, 250117

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

    Nanchang, Jiangxi, 330006

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

    Nanchang, Jiangxi, 330006

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

    Nanjing, Jiangsu, 210000

  • Fudan University Shanghai Cancer Center ( Site 2616)

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)

    Shanghai, Shanghai Municipality, 200433

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

    Tianjin, Tianjin Municipality, 300060

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

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430030

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

    Xi'an, Shaanxi, 710061

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

    Xiamen, Fujian, 361003

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

    Yibin, Sichuan, 644000

  • Henan Cancer Hospital ( Site 2608)

    Zhengzhou, Henan, 450000

Other trials in China

Japan15 sites

  • Hyogo Cancer Center-Thoracic Oncology ( Site 2409)

    Akashi, Hyōgo, 673-8558

  • National Hospital Organization Kyushu Medical Center ( Site 2413)

    Fukuoka, 810-8563

  • National Hospital Organization Kyushu Cancer Center ( Site 2412)

    Fukuoka, 811-1395

  • Kansai Medical University Hospital ( Site 2415)

    Hirakata, Osaka, 573-1191

  • Saitama Prefectural Cancer Center ( Site 2406)

    Ina-machi, Saitama, 362-0806

  • Kanazawa University Hospital ( Site 2407)

    Kanazawa, Ishikawa-ken, 920-8641

  • Japanese Foundation for Cancer Research ( Site 2402)

    Koto, Tokyo, 135-8550

  • National Hospital Organization Shikoku Cancer Center ( Site 2414)

    Matsuyama, Ehime, 791-0280

  • Shizuoka Cancer Center ( Site 2408)

    Nakatogari, Shizuoka, 411-8777

  • Miyagi Cancer Center ( Site 2401)

    Natori-shi, Miyagi, 981-1293

  • Okayama University Hospital ( Site 2410)

    Okayama, 700-8558

  • Showa University Hospital ( Site 2403)

    Shinagawa, Tokyo, 1428666

  • Nippon Medical School Hospital ( Site 2404)

    Tokyo, 113-8603

  • Ehime University Hospital ( Site 2411)

    Tōon, Ehime, 791-0295

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

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

United States12 sites

  • Charleston Oncology ( Site 0019)

    Charleston, South Carolina, 29414

  • University of Virginia Cancer Center ( Site 0018)

    Charlottesville, Virginia, 22903

  • Mount Sinai Hospital ( Site 0011)

    Chicago, Illinois, 60608

  • University of Chicago Medical Center ( Site 0015)

    Chicago, Illinois, 60637

  • UCHealth Memorial Hospital-Heme Onc ( Site 0003)

    Colorado Springs, Colorado, 80909

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

    Fort Collins, Colorado, 80528

  • Cancer and Hematology Centers of Western Michigan ( Site 0002)

    Grand Rapids, Michigan, 49503

  • Mayo Clinic in Florida ( Site 0022)

    Jacksonville, Florida, 32224

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

    Lancaster, Pennsylvania, 17604

  • Mayo Clinic in Rochester, Minnesota ( Site 0030)

    Rochester, Minnesota, 55905

  • New England Cancer Specialists ( Site 0008)

    Scarborough, Maine, 04074

  • Stony Brook University-Cancer Center ( Site 0013)

    Stony Brook, New York, 11794

Other trials in United States

Chile8 sites

  • Centro de Investigación Oncológica del Norte ( Site 0504)

    Antofagasta, 1240000

  • Biocenter ( Site 0514)

    Concepción, Biobio, 4070196

  • FALP-UIDO ( Site 0505)

    Santiago, Region M. de Santiago, 6900941

  • Centro de Oncología de Precisión ( Site 0515)

    Santiago, Region M. de Santiago, 7560908

  • Bradfordhill ( Site 0510)

    Santiago, Region M. de Santiago, 8420383

  • James Lind Centro de Investigación del Cáncer ( Site 0502)

    Temuco, Araucania, 4800827

  • CIDO SpA-Oncology ( Site 0508)

    Temuco, Araucania, 4810148

  • ONCOCENTRO APYS-ACEREY ( Site 0503)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Poland8 sites

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)

    Bystra, Silesian Voivodeship, 43-360

  • Przychodnia Lekarska KOMED ( Site 1902)

    Konin, Greater Poland Voivodeship, 62-500

  • Med-Polonia Sp. z o. o. ( Site 1909)

    Poznan, Greater Poland Voivodeship, 60-693

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

    Prabuty, Pomeranian Voivodeship, 82-550

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

    Przemyśl, Podkarpackie Voivodeship, 37-700

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

    Warsaw, Masovian Voivodeship, 02-781

  • Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)

    Warsaw, Masovian Voivodeship, 04-125

Other trials in Poland

Turkey (Türkiye)8 sites

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

    Adana, 01250

  • Hacettepe Universitesi-oncology hospital ( Site 1202)

    Ankara, 06230

  • Liv Hospital Ankara-Oncology ( Site 1205)

    Ankara, 06680

  • Ankara City Hospital ( Site 1204)

    Ankara, 06800

  • Trakya University-Medical Oncology ( Site 1203)

    Edirne, 22030

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

    Istanbul, 34722

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

    Istanbul, 34766

  • Acibadem Altunizade Hospital-Oncology ( Site 1207)

    Üsküdar / Stanbul, Istanbul, 34662

Other trials in Turkey (Türkiye)

Argentina7 sites

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

    ABB, Buenos Aires F.D., C1199ABB

  • Centro de Oncología e Investigación de Buenos Aires ( Site 0203)

    Berazategui, Buenos Aires, B1884BBF

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)

    Buenos Aires, Buenos Aires F.D., C1431FWO

  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)

    La Rioja, F5300COE

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

    Mar del Plata, Buenos Aires, B7600FZO

  • Sanatorio Parque ( Site 0205)

    Rosario, Santa Fe Province, 2000

  • Hospital Provincial del Centenario ( Site 0212)

    Rosario, Santa Fe Province, 2002

Other trials in Argentina

France7 sites

  • Institut de Cancérologie de l'Ouest ( Site 0802)

    Angers, Maine-et-Loire, 49055

  • Centre Hospitalier d'Avignon ( Site 0810)

    Avignon, Vaucluse, 84000

  • Centre Hospitalier d'Annecy ( Site 0807)

    Epagny Metz-Tessy, Haute-Savoie, 74370

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

    Lille, Hauts-de-France, 59037

  • CENTRE LEON BERARD ( Site 0803)

    Lyon, Rhone, 69373

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

    Orléans, Centre-Val de Loire, 45067

  • HIA Sainte Anne ( Site 0804)

    Toulon, Var, 83800 Cedex 9

Other trials in France

Austria6 sites

  • Medizinische Universität Graz ( Site 0704)

    Graz, Styria, 8036

  • Medizinische Universitaet Innsbruck ( Site 0703)

    Innsbruck, Tyrol, 6020

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

    Linz, Upper Austria, 4020

  • Kepler Universitätsklinikum ( Site 0707)

    Linz, Upper Austria, 4021

  • Klinik Penzing-2. Lungenabteilung ( Site 0702)

    Vienna, State of Vienna, 1140

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

    Vienna, 1210

Other trials in Austria

South Korea6 sites

  • Pusan National University Hospital ( Site 2205)

    Busan, Pusan-Kwangyokshi, 49241

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

    Daejeon, Taejon-Kwangyokshi, 35015

  • Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)

    Deagu, Taegu-Kwangyokshi, 41404

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

    Hwasun, Jeonranamdo, 58128

  • Korea University Guro Hospital-Internal Medicine ( Site 2204)

    Seoul

  • Asan Medical Center ( Site 2206)

    Songpa-gu, Seoul, 05505

Other trials in South Korea

Spain6 sites

  • CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106)

    A Coruña, La Coruna, 15006

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

    Barcelona, 08035

  • Hospital Insular de Gran Canaria-Oncology ( Site 1102)

    Las Palmas de Gran Canaria, Las Palmas, 35001

  • Hospital Clinico San Carlos-Oncology Department ( Site 1107)

    Madrid, 28040

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

    Seville, 41009

  • Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105)

    Zaragoza, 50009

Other trials in Spain

Brazil5 sites

  • Clínica de Oncologia Reichow ( Site 0407)

    Blumenau, Santa Catarina, 89010-340

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

    Natal, Rio Grande do Norte, 59075-740

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

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)

    Rio de Janeiro, 20230-130

  • Hospital Paulistano ( Site 0401)

    São Paulo, 01321-001

Other trials in Brazil

Colombia5 sites

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

    Bogotá, Bogota D.C., 110221

  • Fundación Colombiana de Cancerología Clínica Vida ( Site 0603)

    Medellín, Antioquia, 050030

  • Oncomedica S.A.-Oncomedica S.A ( Site 0609)

    Montería, Departamento de Córdoba, 230001

  • Oncologos del Occidente ( Site 0608)

    Pereira, Risaralda Department, 660001

  • Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Germany5 sites

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

    Berlin, 13353

  • GEFOS Gesellschaft f. onkologische Studien ( Site 0909)

    Dortmund, North Rhine-Westphalia, 44263

  • SRH Wald-Klinikum Gera ( Site 0911)

    Gera, Thuringia, 07548

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

    Giessen, Hesse, 35392

  • Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)

    Lübeck, Schleswig-Holstein, 23538

Other trials in Germany

Israel5 sites

  • Rambam Health Care Campus-Oncology ( Site 1303)

    Haifa, 3109601

  • Shaare Zedek Medical Center-Oncology ( Site 1306)

    Jerusalem, 9013102

  • Meir Medical Center-oncology ( Site 1301)

    Kfar Saba, 4428164

  • Sheba Medical Center-ONCOLOGY ( Site 1302)

    Ramat Gan, 5265601

  • Sourasky Medical Center-Oncology ( Site 1305)

    Tel Aviv, 6423906

Other trials in Israel

Taiwan5 sites

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

    Kaohsiung City, 807

  • China Medical University Hospital ( Site 2253)

    Taichung, 40447

  • NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252)

    Tainan, 704

  • National Taiwan University Hospital-Oncology ( Site 2255)

    Taipei, 100

  • Chang Gung Medical Foundation-Linkou Branch ( Site 2251)

    Taoyuan, 333

Other trials in Taiwan

Thailand5 sites

  • Faculty of Medicine Siriraj Hospital ( Site 2304)

    Bangkok, Bangkok, 10700

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

    Chiang Mai, 50200

  • Songklanagarind hospital ( Site 2302)

    Hat Yai, Changwat Songkhla, 90110

  • Chulabhorn Hospital ( Site 2305)

    Lak Si, Bangkok, 10210

  • Faculty of Medicine - Khon Kaen University ( Site 2303)

    Muang, Changwat Khon Kaen, 40002

Other trials in Thailand

Mexico4 sites

  • Hospital Civil Fray Antonio Alcalde ( Site 0307)

    Guadalajara, Jalisco, 44280

  • Arké SMO S.A. de C.V. ( Site 0301)

    Mexico City, Mexico City, 06700

  • Alivia Clínica de Alta Especialidad ( Site 0310)

    Mexico City, Mexico City, 06760

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

    Saltillo, Coahuila, 25279

Other trials in Mexico

United Kingdom4 sites

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

    Leicester, England

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

    London, England, SW10 9NH

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

    London, London, City of, EC1A 7BE

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

    London-Camden, London, City of, NW1 2PG

Other trials in United Kingdom

About this study

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)

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%.

Read the detailed description

Effective as of Amendment 5, Participants receiving coformulation of pembrolizumab/vibostolimab plus chemotherapy will be transitioned to standard of care (SOC, pembrolizumab plus chemotherapy). Participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from pembrolizumab plus chemotherapy, but unable to access it as SOC outside the study, may continue on study and receive treatment with pembrolizumab plus chemotherapy until discontinuation criteria are met.

Being tested
Pembrolizumab/Vibostolimab, Carboplatin, Cisplatin, Paclitaxel, Nab-paclitaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab/VibostolimabBiological

    Also called MK-7684A

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

  • CarboplatinDrug

    Also called PARAPLATIN®, Paraplatin NovaPlus ®

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

  • CisplatinDrug

    Also called Platinol-AQ®

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

  • PaclitaxelDrug

    Also called TAXOL®, ONXOL®

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

  • Nab-paclitaxelDrug

    Also called ABRAXANE®

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

  • PemetrexedDrug

    Also called Alimta®

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

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

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

Study groups in NCT05226598
Study groupRoleWhat they receive
MK-7684A + ChemotherapyExperimentalParticipants receive pembrolizumab/vibostolimab (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Receives: Biological: Pembrolizumab/Vibostolimab; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Pemetrexed
Pembrolizumab + ChemotherapyActive comparatorParticipants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Pemetrexed; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%

    OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (PD-L1 TPS≥1%). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to approximately 29 months

Secondary outcomes (18)

  1. Overall Survival (OS) in All Participants

    OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all randomized participants. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to approximately 29 months

  2. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) was planned to be presented.

    Measured: Up to approximately 29 months

  3. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by blinded independent central review (BICR) was planned to be presented.

    Measured: Up to approximately 29 months

  4. Duration of Response (DOR)

    For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by BICR was planned to be presented.

    Measured: Up to approximately 29 months

  5. Change From Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 was planned to be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.

    Measured: Baseline and Up to approximately 29 months

  6. Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

    Change from baseline in the score of EORTC QLQ-C30 Items 1-5 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.

    Measured: Baseline and Up to approximately 29 months

  7. Change From Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30

    Change from baseline in the score of EORTC QLQ-C30 Items 6-7 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.

    Measured: Baseline and up to approximately 29 months

  8. Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30

    Change from baseline in the score of EORTC QLQ-C30 Item 8 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.

    Measured: Baseline and Up to approximately 29 months

  9. Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)

    Change from baseline in the score of EORTC QLQ-LC13 Item 31 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.

    Measured: Baseline and Up to approximately 29 months

  10. Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13

    Change from baseline in the score of EORTC QLQ-LC13 Item 40 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.

    Measured: Baseline and Up to approximately 29 months

  11. Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30

    TTD in the score of EORTC QLQ-C30 Items 29 and 30 was planned to be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

    Measured: Up to approximately 29 months

  12. TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30

    TTD in the score of EORTC QLQ-C30 Items 1-5 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

    Measured: Up to approximately 29 months

  13. TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30

    TTD in the score of EORTC QLQ-C30 Items 6-7 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

    Measured: Up to approximately 29 months

  14. TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30

    TTD in the score of EORTC QLQ-C30 Item 8 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

    Measured: Up to approximately 29 months

  15. TTD in Cough Score (Item 31) on the EORTC QLQ-LC13

    TTD in the score of EORTC QLQ-LC13 Item 31 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

    Measured: Up to approximately 29 months

  16. TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

    TTD in the score of EORTC QLQ-LC13 Item 40 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

    Measured: Up to approximately 29 months

  17. Number of Participants Who Experienced One or More Adverse Events (AEs)

    The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.

    Measured: Up to approximately 46 months

  18. Number of Participants Who Discontinued Study Intervention Due to an AE

    The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.

    Measured: Up to approximately 46 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start24 Mar 2022
  3. Primary completion24 Sep 2024
  4. Study completion9 Jan 2026

Why it stopped: MK-7684A-007 was terminated early due to futility. A non-submission CSR, not intended to support any registration, was issued; therefore, an abbreviated CSR was generated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
739 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05226598
Sponsor's protocol ID
7684A-007
Other IDs
MK-7684A-007, KEYVIBE-007, jRCT2031220098, 2023-506074-12-00, U1111-1293-2114, 2023
Status last verified
Aug 2026
First submitted
26 Jan 2022
Last updated
11 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Shapira-Frommer R, Niu J, Perets R, Peters S, Shouse G, Lugowska I, Garassino MC, Sands J, Keenan T, Zhao B, Healy J, Ahn MJ. The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies. Future Oncol. 2024;20(27):1983-1991. doi: 10.1080/14796694.2024.2343272. Epub 2024 Sep 4.

    PubMed 39230120

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab/Vibostolimab, Carboplatin and Cisplatin in people with Metastatic Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 149 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in China, Japan, United States, Chile, Poland and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% (time frame: Up to approximately 29 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05226598, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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