Clinical trial NCT05226598: 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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Metastatic Non-Small Cell Lung Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 739
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 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 treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

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.

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 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
* 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

Primary outcomes:
measure: Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
timeFrame: Up to approximately 30 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 30 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 30 months
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 30 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 26 months
measure: Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
timeFrame: Baseline and Up to approximately 26 months
measure: Change from Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
timeFrame: Baseline and up to approximately 26 months
measure: Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
timeFrame: Baseline and Up to approximately 26 months
measure: 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)
timeFrame: Baseline and Up to approximately 26 months
measure: Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13
timeFrame: Baseline and Up to approximately 26 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 26 months
measure: TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30
timeFrame: Up to approximately 26 months
measure: TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
timeFrame: Up to approximately 26 months
measure: TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
timeFrame: Up to approximately 26 months
measure: TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
timeFrame: Up to approximately 26 months
measure: TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
timeFrame: Up to approximately 26 months
measure: Number of Participants Who Experienced One or More Adverse Events (AEs)
timeFrame: Up to approximately 53 months
measure: Number of Participants Who Discontinued Study Intervention Due to an AE
timeFrame: Up to approximately 53 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 30 months
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital-Heme Onc ( Site 0003)
state: Colorado
city: Fort Collins
country: United States
facility: University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida ( Site 0022)
state: Florida
city: Chicago
country: United States
facility: Mount Sinai Hospital ( Site 0011)
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center ( Site 0015)
state: Illinois
city: Scarborough
country: United States
facility: New England Cancer Specialists ( Site 0008)
state: Maine
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan ( Site 0002)
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota ( Site 0030)
state: Minnesota
city: Stony Brook
country: United States
facility: Stony Brook University-Cancer Center ( Site 0013)
state: New York
city: Lancaster
country: United States
facility: Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Oncology ( Site 0019)
state: South Carolina
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center ( Site 0018)
state: Virginia
city: Berazategui
country: Argentina
facility: Centro de Oncología e Investigación de Buenos Aires ( Site 0203)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204)
state: Buenos Aires
city: ABB
country: Argentina
facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)
state: Caba
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)
state: Caba
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0205)
state: Santa Fe
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario ( Site 0212)
state: Santa Fe
city: La Rioja
country: Argentina
facility: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)
state: Oberosterreich
city: Linz
country: Austria
facility: Kepler Universitätsklinikum ( Site 0707)
state: Oberosterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz ( Site 0704)
state: Steiermark
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck ( Site 0703)
state: Tirol
city: Vienna
country: Austria
facility: Klinik Penzing-2. Lungenabteilung ( Site 0702)
state: Wien
city: Wien
country: Austria
facility: Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701)
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403)
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405)
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Clínica de Oncologia Reichow ( Site 0407)
state: Santa Catarina
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano ( Site 0401)
city: Temuco
country: Chile
facility: James Lind Centro de Investigación del Cáncer ( Site 0502)
state: Araucania
city: Temuco
country: Chile
facility: CIDO SpA-Oncology ( Site 0508)
state: Araucania
city: Concepción
country: Chile
facility: Biocenter ( Site 0514)
state: Biobio
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0505)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Oncología de Precisión ( Site 0515)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 0510)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS-ACEREY ( Site 0503)
state: Valparaiso
city: Antofagasta
country: Chile
facility: Centro de Investigación Oncológica del Norte ( Site 0504)
city: Hefei
country: China
facility: Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital-oncology department ( Site 2621)
state: Fujian
city: Xiamen City
country: China
facility: The First Affiliated hospital of Xiamen University ( Site 2626)
state: Fujian
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital-oncology of department ( Site 2604)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 2608)
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618)
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 2617)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University-Oncology department ( Site 2627)
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University ( Site 2623)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 2622)
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625)
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624)
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital-oncology department ( Site 2603)
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607)
state: Shaanxi
city: Jinan
country: China
facility: Shandong Cancer Hospital-Oncology Department ( Site 2630)
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 2616)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital of Sichuan University ( Site 2610)
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer hospital ( Site 2628)
state: Sichuan
city: Yibin
country: China
facility: The Second People's Hospital of Yibin ( Site 2629)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606)
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital-Oncology ( Site 2612)
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
state: Zhejiang
city: Medellin
country: Colombia
facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 0603)
state: Antioquia
city: Valledupar
country: Colombia
facility: Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)
state: Cesar
city: Montería
country: Colombia
facility: Oncomedica S.A.-Oncomedica S.A ( Site 0609)
state: Cordoba
city: Bogotá
country: Colombia
facility: Administradora Country S.A. - Clinica del Country ( Site 0601)
state: Distrito Capital De Bogota
city: Pereira
country: Colombia
facility: Oncologos del Occidente ( Site 0608)
state: Risaralda
city: Orléans
country: France
facility: CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806)
state: Centre
city: Epagny Metz-Tessy
country: France
facility: Centre Hospitalier d'Annecy ( Site 0807)
state: Haute-Savoie
city: ANGERS cedex 02
country: France
facility: Institut de Cancérologie de l'Ouest ( Site 0802)
state: Maine-et-Loire
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th
state: Nord-Pas-de-Calais
city: Lyon CEDEX 08
country: France
facility: CENTRE LEON BERARD ( Site 0803)
state: Rhone
city: Toulon
country: France
facility: HIA Sainte Anne ( Site 0804)
state: Var
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon ( Site 0810)
state: Vaucluse
city: Gießen
country: Germany
facility: UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)
state: Hessen
city: Dortmund
country: Germany
facility: GEFOS Gesellschaft f. onkologische Studien ( Site 0909)
state: Nordrhein-Westfalen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)
state: Schleswig-Holstein
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera ( Site 0911)
state: Thuringen
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology ( Site 1303)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center-Oncology ( Site 1306)
city: Kfar Saba
country: Israel
facility: Meir Medical Center-oncology ( Site 1301)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-ONCOLOGY ( Site 1302)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center-Oncology ( Site 1305)
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 2414)
state: Ehime
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 2411)
state: Ehime
city: Akashi
country: Japan
facility: Hyogo Cancer Center-Thoracic Oncology ( Site 2409)
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 2407)
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405)
state: Kanagawa
city: Natori
country: Japan
facility: Miyagi Cancer Center ( Site 2401)
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 2415)
state: Osaka
city: Ina-machi
country: Japan
facility: Saitama Prefectural Cancer Center ( Site 2406)
state: Saitama
city: Nagaizumi
country: Japan
facility: Shizuoka Cancer Center ( Site 2408)
state: Shizuoka
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research ( Site 2402)
state: Tokyo
city: Shinagawa
country: Japan
facility: Showa University Hospital ( Site 2403)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 2413)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 2412)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 2410)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 2404)
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201)
state: Jeonranamdo
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital ( Site 2205)
state: Pusan-Kwangyokshi
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center ( Site 2206)
state: Seoul
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)
state: Taegu-Kwangyokshi
city: Daejeon
country: Korea, Republic of
facility: Chungnam national university hospital-Department of Internal Medicine ( Site 2203)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital-Internal Medicine ( Site 2204)
city: Saltillo
country: Mexico
facility: CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304)
state: Coahuila
city: Ciudad de Mexico
country: Mexico
facility: Alivia Clínica de Alta Especialidad ( Site 0310)
state: Distrito Federal
city: Mexico
country: Mexico
facility: Arké SMO S.A. de C.V. ( Site 0301)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde ( Site 0307)
state: Jalisco
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903)
state: Kujawsko-pomorskie
city: Warsaw
country: Poland
facility: Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904)
state: Podkarpackie
city: Prabuty
country: Poland
facility: Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906)
state: Pomorskie
city: Bystra
country: Poland
facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)
state: Slaskie
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED ( Site 1902)
state: Wielkopolskie
city: Poznan
country: Poland
facility: Med-Polonia Sp. z o. o. ( Site 1909)
state: Wielkopolskie
city: A Coruña
country: Spain
facility: CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106)
state: La Coruna
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria-Oncology ( Site 1102)
state: Las Palmas
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos-Oncology Department ( Site 1107)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103)
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 2253)
city: Tainan
country: Taiwan
facility: NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Oncology ( Site 2255)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 2251)
city: Muang
country: Thailand
facility: Faculty of Medicine - Khon Kaen University ( Site 2303)
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 2304)
state: Krung Thep Maha Nakhon
city: Lak Si
country: Thailand
facility: Chulabhorn Hospital ( Site 2305)
state: Krung Thep Maha Nakhon
city: Hatyai
country: Thailand
facility: Songklanagarind hospital ( Site 2302)
state: Songkhla
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301)
city: Üsküdar / Stanbul
country: Turkey
facility: Acibadem Altunizade Hospital-Oncology ( Site 1207)
state: Istanbul
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi-oncology hospital ( Site 1202)
city: Ankara
country: Turkey
facility: Liv Hospital Ankara-Oncology ( Site 1205)
city: Ankara
country: Turkey
facility: Ankara City Hospital ( Site 1204)
city: Edirne
country: Turkey
facility: Trakya University-Medical Oncology ( Site 1203)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209)
city: Istanbul
country: Turkey
facility: Umraniye Training and Research Hospital-medical oncology ( Site 1206)
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)
state: England
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501)
state: England
city: London-Camden
country: United Kingdom
facility: University College London Hospital-Cancer Clinical Trials Unit ( Site 1509)
state: London, City Of
city: London
country: United Kingdom
facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506)
state: London, City Of
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: