Clinical trial NCT05609968: Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Programmed Cell Death-2 (PD2, PD-2)
Programmed Death-Ligand 2 (PDL2, PD-L2)
Trophoblast Cell Surface Antigen-2 (TROP-2)
Antibody-Drug Conjugate (ADC)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2022-11-08
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

* Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
* Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC
* Has previously received treatment with Topoisomerase 1 inhibitors or Trop-2 targeted therapy
* Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
* Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities requiring corticosteroids
* Has received radiation therapy to the lung that is \>30 Gray (Gy) within 6 months of the first dose of study intervention
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
* Has cardiac disease

  * Myocardial infarction or unstable angina pectoris within 6 months of enrollment
  * History of serious ventricular arrhythmia, high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications; history of QT interval prolongation
  * New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of \<40%
* Has active chronic inflammatory bowel disease
* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab or sacituzumab govitecan and/or any of their excipients
* Has active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy
* Has history of human immunodeficiency virus (HIV) infection
* History of hepatitis B or known active hepatitis C virus infection
* Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
* Have not adequately recovered from major surgery or have ongoing surgical complications

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 34 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 48 months
Secondary outcomes:
measure: Objective Response (OR)
timeFrame: Up to approximately 34 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 48 months
measure: 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)
timeFrame: Baseline and up to approximately 48 months
measure: Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
timeFrame: Baseline and up to approximately 48 months
measure: Change from Baseline in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30
timeFrame: Baseline and up to approximately 48 months
measure: Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
timeFrame: Baseline and up to approximately 48 months
measure: Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13)
timeFrame: Baseline and up to approximately 48 months
measure: Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
timeFrame: Baseline and up to approximately 48 months
measure: Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
timeFrame: Up to approximately 48 months
measure: TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
timeFrame: Up to approximately 48 months
measure: TTD in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30
timeFrame: Up to approximately 48 months
measure: TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 11
timeFrame: Up to approximately 48 months
measure: TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
timeFrame: Up to approximately 48 months
measure: TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
timeFrame: Up to approximately 48 months
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 48 months
measure: Number of Participants Who Discontinue Study Treatment Due To an AE
timeFrame: Up to approximately 48 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Infirmary Cancer Care ( Site 0418)
state: Alabama
city: Clermont
country: United States
facility: Clermont Oncology Center ( Site 0421)
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417)
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center ( Site 0416)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407)
state: Georgia
city: Baton Rouge
country: United States
facility: Our Lady of the Lake RMC ( Site 0424)
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital ( Site 0412)
state: Michigan
city: Farmington Hills
country: United States
facility: Profound Research LLC ( Site 0440)
state: Michigan
city: Minneapolis
country: United States
facility: Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0425)
state: Minnesota
city: Inwood
country: United States
facility: Basil Clinical ( Site 0441)
state: New York
city: White Plains
country: United States
facility: White Plains Hospital-Center for Cancer Care ( Site 0403)
state: New York
city: Portland
country: United States
facility: Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408)
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University ( Site 0427)
state: Oregon
city: Houston
country: United States
facility: Houston Methodist Hospital ( Site 0419)
state: Texas
city: Temple
country: United States
facility: Central Texas Veterans health care ( Site 0414)
state: Texas
city: Orange
country: Australia
facility: Orange Hospital-Clinical Trials Unit ( Site 0600)
state: New South Wales
city: Adelaide
country: Australia
facility: Cancer Research SA-St Andrews Hospital ( Site 0603)
state: South Australia
city: Frankston
country: Australia
facility: Frankston Hospital-Oncology and Haematology ( Site 0601)
state: Victoria
city: Fortaleza
country: Brazil
facility: CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0320)
state: Ceara
city: Bento Goncalves
country: Brazil
facility: Hospital Tacchini ( Site 0322)
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Hospital da Cidade de Passo Fundo ( Site 0321)
state: Rio Grande Do Sul
city: Santa Cruz do Sul
country: Brazil
facility: Instituto de Oncologia Saint Gallen ( Site 0317)
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0318)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: A. C. Camargo Cancer Center ( Site 0324)
city: Abbotsford
country: Canada
facility: BC Cancer Abbotsford-Medical Oncology ( Site 0433)
state: British Columbia
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre-Oncology Clinical Trials ( Site 0435)
state: Ontario
city: Greenfield Park
country: Canada
facility: Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0430)
state: Quebec
city: Montreal
country: Canada
facility: St. Marys Hospital Center-Oncology ( Site 0434)
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre integre universitaire de sante et de services sociaux-oncology ( Site 0431)
state: Quebec
city: Santiago.
country: Chile
facility: Oncovida ( Site 0334)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0332)
state: Region M. De Santiago
city: Hefei
country: China
facility: Second Affiliated hospital of Anhui Medical University ( Site 0126)
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital ( Site 0136)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer hospital ( Site 0104)
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital-pneumology department ( Site 0106)
state: Beijing
city: Beijing
country: China
facility: Beijing Chest Hospital,Capital Medical University ( Site 0105)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital-Medical Oncology ( Site 0130)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 0131)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University ( Site 0132)
state: Fujian
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0125)
state: Guangdong
city: Nanning
country: China
facility: Affiliated Cancer Hospital of Guangxi Medical University ( Site 0113)
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 0119)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 0127)
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 0116)
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0115)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 0107)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University ( Site 0124)
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University ( Site 0135)
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0112)
state: Jiangsu
city: Nantong
country: China
facility: Nantong Tumor Hospital-Medical Oncology ( Site 0122)
state: Jiangsu
city: Suzhou
country: China
facility: The First Affliated Hospital of Suzhou University ( Site 0114)
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University ( Site 0134)
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University ( Site 0117)
state: Jilin
city: Changchun
country: China
facility: Jilin Province Tumor Hospital-clinical research ( Site 0118)
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0133)
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital-oncology department ( Site 0121)
state: Shandong
city: Linyi
country: China
facility: LinYi Cancer Hospital ( Site 0120)
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital ( Site 0101)
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center-Oncology ( Site 0102)
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University ( Site 0103)
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital of Sichuan University ( Site 0129)
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer hospital. ( Site 0128)
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University ( Site 0109)
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0110)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital-Medical Oncology ( Site 0111)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 0108)
state: Zhejiang
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation-Chemotherapy ( Site 0621)
state: Harjumaa
city: Tartu
country: Estonia
facility: Tartu University Hospital-Radiotherapy and oncology ( Site 0620)
state: Tartumaa
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim ( Site 0654)
state: Baden-Wurttemberg
city: Kempten
country: Germany
facility: Klinikum Kempten ( Site 0655)
state: Bayern
city: Wuerzburg
country: Germany
facility: Klinikum Würzburg Mitte ( Site 0651)
state: Bayern
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz ( Site 0650)
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 0657)
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- ( Site 0656)
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 0653)
city: Athens
country: Greece
facility: Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 0141)
state: Attiki
city: Athens
country: Greece
facility: Sotiria Thoracic Diseases Hospital of Athens-3rd Dept of Internal Medicine, Oncology Unit ( Site 0140)
state: Attiki
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center-Oncology Department ( Site 0142)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center-Oncology ( Site 0176)
city: KfarSaba
country: Israel
facility: Meir Medical Center-oncology ( Site 0171)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center-Oncology ( Site 0174)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center-Oncology ( Site 0175)
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center. ( Site 0179)
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0677)
state: Lazio
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0674)
state: Lombardia
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0673)
state: Lombardia
city: Naples
country: Italy
facility: Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 0671)
state: Napoli
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0675)
state: Toscana
city: Peschiera del Garda
country: Italy
facility: Casa di Cura Dott. Pederzoli-LUNG-UNIT TORACIC ( Site 0670)
state: Verona
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 0676)
city: Nagoya
country: Japan
facility: Aichi Cancer Center ( Site 0018)
state: Aichi
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 0008)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 0014)
state: Fukuoka
city: Takarazuka
country: Japan
facility: Takarazuka City Hospital ( Site 0015)
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 0019)
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0016)
state: Kanagawa
city: Natori
country: Japan
facility: Miyagi Cancer Center ( Site 0001)
state: Miyagi
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 0012)
state: Miyagi
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital ( Site 0017)
state: Niigata
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital ( Site 0011)
state: Okayama
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 0005)
state: Osaka
city: Sayama
country: Japan
facility: Kindai University Hospital ( Site 0013)
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Prefectural Cancer Center ( Site 0002)
state: Saitama
city: Nagaizumi-cho,Sunto-gun
country: Japan
facility: Shizuoka Cancer Center ( Site 0004)
state: Shizuoka
city: Bunkyo ku
country: Japan
facility: Tokyo Metropolitan Komagome Hospital ( Site 0020)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 0009)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0010)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 0007)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 0003)
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital ( Site 0006)
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital-Pulmonology ( Site 0061)
state: Jeonranamdo
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital ( Site 0060)
state: Kyongsangnam-do
city: Daejeon
country: Korea, Republic of
facility: Chungnam national university hospital-Department of Internal Medicine ( Site 0063)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0064)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital-Internal Medicine ( Site 0062)
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital-Oncology Department ( Site 0194)
state: Daugavpils Novads
city: Liepaja
country: Latvia
facility: Liepjas reionl slimnca ( Site 0191)
city: Riga
country: Latvia
facility: Pauls Stradins Clinical Univeristy Hospital-Chemotherapy department ( Site 0192)
city: Riga
country: Latvia
facility: RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia-Out-patient and Day patient facility of Ch ( Site 0193)
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 0692)
state: Kauno Apskritis
city: Vilnius
country: Lithuania
facility: National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 0691)
state: Vilniaus Miestas
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II-Medical Department ( Site 0035)
state: Kelantan
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 0034)
state: Pulau Pinang
city: Petaling Jaya
country: Malaysia
facility: Beacon Hospital Sdn Bhd ( Site 0033)
state: Selangor
city: Tijuana
country: Mexico
facility: COI Tijuana - Centro Oncológico Internacional ( Site 0350)
state: Baja California
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0352)
state: Nuevo Leon
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization ( Site 0346)
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 0351)
city: Arequipa
country: Peru
facility: Clinica Vallesur - AUNA ( Site 0360)
state: Ariqipa
city: Concepcion
country: Peru
facility: Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0362)
state: Junin
city: Trujillo
country: Peru
facility: Centro de investigacion Clínica Trujillo ( Site 0358)
state: La Libertad
city: Surquillo
country: Peru
facility: Detecta Clínica ( Site 0364)
state: Lima
city: Lima
country: Peru
facility: Clínica Internacional - Sede San Borja ( Site 0356)
city: Lima
country: Peru
facility: Instituto Neuro Cardiovascular de las Americas ( Site 0365)
city: Lima
country: Peru
facility: Hospital Cayetano Heredia ( Site 0361)
city: Davao City
country: Philippines
facility: Metro Davao Medical and Research Center ( Site 0047)
state: Davao Del Sur
city: Quezon City
country: Philippines
facility: ST. LUKE'S MEDICAL CENTER ( Site 0046)
state: National Capital Region
city: Cebu
country: Philippines
facility: Cebu Doctors University Hospital ( Site 0045)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0208)
state: Kujawsko-pomorskie
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0201)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0200)
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0203)
state: Podkarpackie
city: Prabuty
country: Poland
facility: Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 0202)
state: Pomorskie
city: Racibórz
country: Poland
facility: Szpital Rejonowy im. dr. J. Rostka w Raciborzu ( Site 0207)
state: Slaskie
city: Poznan
country: Poland
facility: Med-Polonia Sp. z o. o. ( Site 0204)
state: Wielkopolskie
city: București
country: Romania
facility: Gral Medical SRL-Medical Oncology ( Site 0220)
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca ( Site 0217)
state: Cluj
city: Florești
country: Romania
facility: Amethyst Radiotherapy Center-Oncologie Medicala ( Site 0216)
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie-Medical ( Site 0215)
state: Dolj
city: Timisoara
country: Romania
facility: Cabinet Medical Oncomed ( Site 0219)
state: Timis
city: Cluj
country: Romania
facility: Institutul Oncologic-Oncologie Medicala ( Site 0218)
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital ( Site 0078)
state: Taichung
city: Taipei City
country: Taiwan
facility: National Taiwan University Cancer Center (NTUCC) ( Site 0079)
state: Taipei
city: Kaohsiung
country: Taiwan
facility: E-Da hospital ( Site 0075)
city: Taichung
country: Taiwan
facility: China Medical University Hospital-Internal Medicine ( Site 0083)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Clinical Trial Center ( Site 0076)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Internal Medicine ( Site 0080)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 0082)
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 0092)
state: Chiang Mai
city: Bangkok
country: Thailand
facility: Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0097)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 0090)
state: Krung Thep Maha Nakhon
city: Mueang Lampang
country: Thailand
facility: Lampang Cancer Hospital ( Site 0098)
state: Lampang
city: HatYai
country: Thailand
facility: Songklanagarind hospital ( Site 0091)
state: Songkhla
city: Ubon Ratchathani
country: Thailand
facility: Sunpasitthiprasong Hospital ( Site 0093)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 0265)
city: Ankara
country: Turkey
facility: Liv Hospital Ankara-Oncology ( Site 0274)
city: Ankara
country: Turkey
facility: Ankara City Hospital-Medical Oncology ( Site 0268)
city: Edirne
country: Turkey
facility: Trakya University-Medical Oncology ( Site 0270)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0267)
city: Istanbul
country: Turkey
facility: VM Medical Park Pendik Hospital ( Site 0271)
city: Izmir
country: Turkey
facility: I.E.U. Medical Point Hastanesi-Oncology ( Site 0266)
city: Mersin
country: Turkey
facility: Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 0275)
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 0300)
state: Leicestershire
city: London
country: United Kingdom
facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 0302)
state: London, City Of
city: London
country: United Kingdom
facility: University College London Hospital ( Site 0305)
state: London, City Of
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre ( Site 0303)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: