An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator-Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater Than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTE D46/EVOKE-03)
Status: Recruiting
Location: See all (179) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ The main inclusion criteria include but are not limited to the following:
• Has a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
• Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase 1 (ALK-1), or ROS proto-oncogene 1 (ROS-1)-directed therapy is not indicated as primary therapy
• Has provided tumor tissue that demonstrates PD-L1 tumor proportion score (TPS) ≥50% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
• Has a life expectancy of at least 3 months
Locations
United States
Alabama
Infirmary Cancer Care ( Site 0418)
RECRUITING
Mobile
California
Profound Research LLC ( Site 0444)
RECRUITING
Oceanside
Florida
Clermont Oncology Center ( Site 0421)
COMPLETED
Clermont
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417)
COMPLETED
Miami
Mid Florida Hematology and Oncology Center ( Site 0416)
RECRUITING
Orange City
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407)
COMPLETED
Marietta
Louisiana
Our Lady of the Lake RMC ( Site 0424)
RECRUITING
Baton Rouge
Michigan
Henry Ford Hospital ( Site 0412)
COMPLETED
Detroit
Profound Research LLC ( Site 0440)
RECRUITING
Farmington Hills
Minnesota
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0425)
RECRUITING
Minneapolis
New York
Basil Clinical ( Site 0441)
RECRUITING
Inwood
White Plains Hospital-Center for Cancer Care ( Site 0403)
COMPLETED
White Plains
Oregon
Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408)
RECRUITING
Portland
Oregon Health & Science University ( Site 0427)
RECRUITING
Portland
Texas
Houston Methodist Hospital ( Site 0419)
RECRUITING
Houston
Central Texas Veterans health care ( Site 0414)
COMPLETED
Temple
Other Locations
Australia
Cancer Research SA-St Andrews Hospital ( Site 0603)
RECRUITING
Adelaide
Frankston Hospital-Oncology and Haematology ( Site 0601)
RECRUITING
Frankston
Orange Hospital-Clinical Trials Unit ( Site 0600)
RECRUITING
Orange
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0318)
RECRUITING
Barretos
Hospital Tacchini ( Site 0322)
RECRUITING
Bento Gonçalves
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0320)
RECRUITING
Fortaleza
Hospital da Cidade de Passo Fundo ( Site 0321)
RECRUITING
Passo Fundo
Instituto de Oncologia Saint Gallen ( Site 0317)
RECRUITING
Santa Cruz Do Sul
A. C. Camargo Cancer Center ( Site 0324)
RECRUITING
São Paulo
Canada
BC Cancer Abbotsford-Medical Oncology ( Site 0433)
RECRUITING
Abbotsford
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0430)
RECRUITING
Greenfield Park
St. Marys Hospital Center-Oncology ( Site 0434)
RECRUITING
Montreal
Southlake Regional Health Centre-Oncology Clinical Trials ( Site 0435)
RECRUITING
Newmarket
Centre integre universitaire de sante et de services sociaux-oncology ( Site 0431)
RECRUITING
Trois-rivières
Chile
Oncovida ( Site 0334)
RECRUITING
Santiago
Pontificia Universidad Catolica de Chile ( Site 0332)
RECRUITING
Santiago
China
Beijing Cancer hospital ( Site 0104)
ACTIVE_NOT_RECRUITING
Beijing
Beijing Chest Hospital,Capital Medical University ( Site 0105)
ACTIVE_NOT_RECRUITING
Beijing
Beijing Peking Union Medical College Hospital-pneumology department ( Site 0106)
ACTIVE_NOT_RECRUITING
Beijing
Jilin Province Tumor Hospital-clinical research ( Site 0118)
ACTIVE_NOT_RECRUITING
Changchun
The First Hospital of Jilin University ( Site 0117)
ACTIVE_NOT_RECRUITING
Changchun
The Second Xiangya Hospital of Central South University ( Site 0135)
ACTIVE_NOT_RECRUITING
Changsha
Xiangya Hospital Central South University ( Site 0124)
ACTIVE_NOT_RECRUITING
Changsha
Sichuan Cancer hospital. ( Site 0128)
ACTIVE_NOT_RECRUITING
Chengdu
West China Hospital of Sichuan University ( Site 0129)
ACTIVE_NOT_RECRUITING
Chengdu
Chongqing University Cancer Hospital-Medical Oncology ( Site 0130)
ACTIVE_NOT_RECRUITING
Chongqing
Fujian Provincial Cancer Hospital ( Site 0131)
ACTIVE_NOT_RECRUITING
Fuzhou
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0125)
ACTIVE_NOT_RECRUITING
Guangzhou
Sir Run Run Shaw Hospital-Medical Oncology ( Site 0111)
ACTIVE_NOT_RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University ( Site 0109)
ACTIVE_NOT_RECRUITING
Hangzhou
The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0110)
ACTIVE_NOT_RECRUITING
Hangzhou
Zhejiang Cancer Hospital ( Site 0108)
ACTIVE_NOT_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital ( Site 0119)
ACTIVE_NOT_RECRUITING
Harbin
Anhui Provincial Hospital ( Site 0136)
RECRUITING
Hefei
Second Affiliated hospital of Anhui Medical University ( Site 0126)
ACTIVE_NOT_RECRUITING
Hefei
Jinan Central Hospital-oncology department ( Site 0121)
ACTIVE_NOT_RECRUITING
Jinan
LinYi Cancer Hospital ( Site 0120)
ACTIVE_NOT_RECRUITING
Linyi
The Second Affiliated Hospital of Nanchang University ( Site 0134)
ACTIVE_NOT_RECRUITING
Nanchang
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0112)
RECRUITING
Nanjing
Affiliated Cancer Hospital of Guangxi Medical University ( Site 0113)
RECRUITING
Nanning
Nantong Tumor Hospital-Medical Oncology ( Site 0122)
COMPLETED
Nantong
Fudan University Shanghai Cancer Center-Oncology ( Site 0102)
ACTIVE_NOT_RECRUITING
Shanghai
Huashan Hospital, Fudan University ( Site 0103)
ACTIVE_NOT_RECRUITING
Shanghai
Shanghai Chest Hospital ( Site 0101)
ACTIVE_NOT_RECRUITING
Shanghai
The First Affliated Hospital of Suzhou University ( Site 0114)
ACTIVE_NOT_RECRUITING
Suzhou
Hubei Cancer Hospital ( Site 0107)
RECRUITING
Wuhan
Tongji Hospital Tongji Medical,Science & Technology ( Site 0116)
ACTIVE_NOT_RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0115)
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0133)
COMPLETED
Xi'an
The First Affiliated hospital of Xiamen University ( Site 0132)
ACTIVE_NOT_RECRUITING
Xiamen
Henan Cancer Hospital ( Site 0127)
COMPLETED
Zhengzhou
Estonia
North Estonia Medical Centre Foundation-Chemotherapy ( Site 0621)
RECRUITING
Tallinn
Tartu University Hospital-Radiotherapy and oncology ( Site 0620)
RECRUITING
Tartu
Germany
Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 0653)
RECRUITING
Berlin
Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- ( Site 0656)
RECRUITING
Berlin
Krankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 0657)
RECRUITING
Halle
Klinikum Kempten ( Site 0655)
RECRUITING
Kempten (allgäu)
Katholisches Klinikum Koblenz ( Site 0650)
RECRUITING
Koblenz
Universitätsmedizin Mannheim ( Site 0654)
RECRUITING
Mannheim
Klinikum Würzburg Mitte ( Site 0651)
RECRUITING
Würzburg
Greece
Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 0141)
RECRUITING
Athens
Sotiria Thoracic Diseases Hospital of Athens-3rd Dept of Internal Medicine, Oncology Unit ( Site 0140)
RECRUITING
Athens
European Interbalkan Medical Center-Oncology Department ( Site 0142)
RECRUITING
Thessaloniki
Israel
Shaare Zedek Medical Center-Oncology ( Site 0176)
RECRUITING
Jerusalem
Meir Medical Center-oncology ( Site 0171)
COMPLETED
Kfarsaba
Rabin Medical Center-Oncology ( Site 0174)
RECRUITING
Petah Tikva
Sourasky Medical Center-Oncology ( Site 0175)
RECRUITING
Tel Aviv
Yitzhak Shamir Medical Center. ( Site 0179)
RECRUITING
Ẕerifin
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0674)
RECRUITING
Bergamo
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0675)
RECRUITING
Florence
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0673)
RECRUITING
Milan
Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 0671)
RECRUITING
Naples
Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 0676)
RECRUITING
Parma
Casa di Cura Dott. Pederzoli-LUNG-UNIT TORACIC ( Site 0670)
RECRUITING
Peschiera Del Garda
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0677)
RECRUITING
Rome
Japan
Tokyo Metropolitan Komagome Hospital ( Site 0020)
RECRUITING
Bunkyo Ku
Kyushu University Hospital ( Site 0010)
RECRUITING
Fukuoka
National Hospital Organization Kyushu Medical Center ( Site 0009)
RECRUITING
Fukuoka
Kansai Medical University Hospital ( Site 0005)
RECRUITING
Hirakata
Kanazawa University Hospital ( Site 0019)
RECRUITING
Kanazawa
Saitama Prefectural Cancer Center ( Site 0002)
RECRUITING
Kitaadachi-gun
Kurashiki Central Hospital ( Site 0011)
RECRUITING
Kurashiki
Kurume University Hospital ( Site 0014)
RECRUITING
Kurume
National Hospital Organization Shikoku Cancer Center ( Site 0008)
RECRUITING
Matsuyama
Shizuoka Cancer Center ( Site 0004)
RECRUITING
Nagaizumi-cho,sunto-gun
Aichi Cancer Center ( Site 0018)
RECRUITING
Nagoya
Miyagi Cancer Center ( Site 0001)
RECRUITING
Natori-shi
Niigata Cancer Center Hospital ( Site 0017)
RECRUITING
Niigata
Okayama University Hospital ( Site 0007)
RECRUITING
Okayama
Kindai University Hospital ( Site 0013)
RECRUITING
Sayama
Sendai Kousei Hospital ( Site 0012)
RECRUITING
Sendai
Takarazuka City Hospital ( Site 0015)
RECRUITING
Takarazuka
Nippon Medical School Hospital ( Site 0003)
RECRUITING
Tokyo
Wakayama Medical University Hospital ( Site 0006)
RECRUITING
Wakayama
Kanagawa Cancer Center ( Site 0016)
RECRUITING
Yokohama
Latvia
Daugavpils Regional Hospital-Oncology Department ( Site 0194)
RECRUITING
Daugavpils
Liepjas reionl slimnca ( Site 0191)
COMPLETED
Liepāja
Pauls Stradins Clinical Univeristy Hospital-Chemotherapy department ( Site 0192)
RECRUITING
Riga
RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia-Out-patient and Day patient facility of Ch ( Site 0193)
RECRUITING
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 0692)
RECRUITING
Kaunas
Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 0691)
RECRUITING
Vilnius
Malaysia
Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 0034)
RECRUITING
George Town
Hospital Raja Perempuan Zainab II-Medical Department ( Site 0035)
RECRUITING
Kota Bharu
Beacon Hospital Sdn Bhd ( Site 0033)
RECRUITING
Petaling Jaya
Mexico
Centro de Investigacion Medica Aguascalientes ( Site 0340)
RECRUITING
Aguascalientes
Medical Care and Research SA de CV ( Site 0353)
RECRUITING
Mérida
Hospital Universitario Dr. Jose Eleuterio Gonzalez-Servicio de Oncología ( Site 0352)
RECRUITING
Monterrey
Centro de Investigacion Clinica de Oaxaca ( Site 0351)
RECRUITING
Oaxaca City
Oaxaca Site Management Organization ( Site 0346)
RECRUITING
Oaxaca City
COI Tijuana - Centro Oncológico Internacional ( Site 0350)
RECRUITING
Tijuana
Peru
Clinica Vallesur - AUNA ( Site 0360)
RECRUITING
Arequipa
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0362)
RECRUITING
Concepción
Clínica Internacional - Sede San Borja ( Site 0356)
ACTIVE_NOT_RECRUITING
Lima
Hospital Cayetano Heredia ( Site 0361)
RECRUITING
Lima
Instituto Neuro Cardiovascular de las Americas ( Site 0365)
RECRUITING
Lima
Detecta Clínica ( Site 0364)
RECRUITING
Surquillo
Centro de investigacion Clínica Trujillo ( Site 0358)
RECRUITING
Trujillo
Philippines
Cebu Doctors University Hospital ( Site 0045)
RECRUITING
Cebu
Metro Davao Medical and Research Center ( Site 0047)
RECRUITING
Davao City
ST. LUKE'S MEDICAL CENTER ( Site 0046)
RECRUITING
Quezon City
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0208)
RECRUITING
Bydgoszcz
Med-Polonia Sp. z o. o. ( Site 0204)
RECRUITING
Poznan
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 0202)
RECRUITING
Prabuty
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0203)
ACTIVE_NOT_RECRUITING
Przemyśl
Szpital Rejonowy im. dr. J. Rostka w Raciborzu ( Site 0207)
RECRUITING
Racibórz
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0201)
RECRUITING
Siedlce
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0200)
RECRUITING
Warsaw
Republic of Korea
Chungnam national university hospital-Department of Internal Medicine ( Site 0063)
RECRUITING
Daejeon
Chonnam National University Hwasun Hospital-Pulmonology ( Site 0061)
RECRUITING
Hwasun
Pusan National University Yangsan Hospital ( Site 0060)
RECRUITING
Pusan
Asan Medical Center ( Site 0064)
RECRUITING
Seoul
Korea University Guro Hospital-Internal Medicine ( Site 0062)
RECRUITING
Seoul
Romania
Gral Medical SRL-Medical Oncology ( Site 0220)
RECRUITING
Bucharest
Cardiomed SRL Cluj-Napoca ( Site 0217)
RECRUITING
Cluj-napoca
Institutul Oncologic-Oncologie Medicala ( Site 0218)
RECRUITING
Cluj-napoca
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 0215)
RECRUITING
Craiova
Amethyst Radiotherapy Center-Oncologie Medicala ( Site 0216)
RECRUITING
Florești
Cabinet Medical Oncomed ( Site 0219)
RECRUITING
Timișoara
Taiwan
E-Da hospital ( Site 0075)
RECRUITING
Kaohsiung City
China Medical University Hospital-Internal Medicine ( Site 0083)
RECRUITING
Taichung
Chung Shan Medical University Hospital ( Site 0078)
COMPLETED
Taichung
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0076)
COMPLETED
Tainan City
National Taiwan University Hospital-Internal Medicine ( Site 0080)
RECRUITING
Taipei
National Taiwan University Cancer Center (NTUCC) ( Site 0079)
RECRUITING
Taipei City
Chang Gung Medical Foundation-Linkou Branch ( Site 0082)
RECRUITING
Taoyuan District
Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0097)
RECRUITING
Bangkok
Faculty of Medicine Siriraj Hospital ( Site 0090)
RECRUITING
Bangkok
Songklanagarind hospital ( Site 0091)
RECRUITING
Hat Yai
Lampang Cancer Hospital ( Site 0098)
RECRUITING
Lampang
Maharaj Nakorn Chiang Mai Hospital ( Site 0092)
RECRUITING
Muang
Sunpasitthiprasong Hospital ( Site 0093)
ACTIVE_NOT_RECRUITING
Ubon Ratchathani
Turkey
Ankara City Hospital-Medical Oncology ( Site 0268)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0265)
RECRUITING
Ankara
Liv Hospital Ankara-Oncology ( Site 0274)
RECRUITING
Ankara
Trakya University-Medical Oncology ( Site 0270)
RECRUITING
Edirne
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0267)
RECRUITING
Istanbul
VM Medical Park Pendik Hospital ( Site 0271)
RECRUITING
Istanbul
I.E.U. Medical Point Hastanesi-Oncology ( Site 0266)
RECRUITING
Izmir
Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 0275)
RECRUITING
Mersin
United Kingdom
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 0300)
RECRUITING
Leicester
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 0302)
RECRUITING
London
University College London Hospital ( Site 0305)
COMPLETED
London
The Clatterbridge Cancer Centre ( Site 0303)
RECRUITING
Metropolitan Borough Of Wirral
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2028-08-23
Participants
Target number of participants: 614
Treatments
Experimental: Pembrolizumab + Sacituzumab Govitecan
Participants receive sacituzumab govitecan 10mg/kg intravenous (IV) infusion once weekly on Day 1 and Day 8 of a continuous 21-day cycle until progressive disease (PD) requiring discontinuation, unacceptable toxicity, withdrawal of consent, or death. Participants receive pembrolizumab 200mg IV infusion on Day 1 every 3 weeks (Q3W) for up to 35 cycles (each cycle length = 21 days).
Experimental: Pembrolizumab
Participants receive pembrolizumab 200mg IV infusion on Day 1 Q3W for up to 35 cycles (each cycle length = 21 days).
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC
Collaborators: Gilead Sciences