Clinical trial NCT06717347: A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)
Official title: A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: Lymphoma, Large B-Cell, Diffuse
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-12-05
Enrollment: 1046
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.


Eligibility criteria: Inclusion Criteria:

* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues
* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale
* Has received no prior treatment for their DLBCL
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria:

* Has a history of transformation of indolent disease to DLBCL
* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma
* Has Ann Arbor Stage I DLBCL
* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication
* Has clinically significant pericardial or pleural effusion
* Has ongoing Grade \>1 peripheral neuropathy
* Has a demyelinating form of Charcot-Marie-Tooth disease
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has ongoing corticosteroid therapy
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
* Known additional malignancy that is progressing or has required active treatment within the past 2 years
* Known active central nervous system (CNS) lymphoma
* Has active autoimmune disease that has required systemic treatment in the past 2 years
* Has active infection requiring systemic therapy
* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection
* Has history of allogeneic tissue/solid organ transplant

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to ~ 50 months
Secondary outcomes:
measure: Complete Response at End of Treatment (CR at EOT)
timeFrame: Up to ~ 32 months
measure: Overall Survival (OS)
timeFrame: Up to ~ 74 months
measure: Event-free Survival (EFS)
timeFrame: Up to ~ 74 months
measure: Duration of Complete Response (DurCR)
timeFrame: Up to ~ 74 months
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to ~ 9 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to ~ 6 months
measure: Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI) Score
timeFrame: Baseline and Week 25
measure: Change From Baseline in HRQoL on FACT-Lym Total Score
timeFrame: Baseline and Week 25
measure: Change From Baseline in HRQoL on FACT-Lym Physical Wellbeing (PWB) Score
timeFrame: Baseline and Week 25
measure: Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score
timeFrame: Baseline and Week 25
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Cancer Center - North Campus ( Site 0124)
state: Arizona
city: Los Alamitos
country: United States
facility: Cancer Blood and Specialty Clinic ( Site 0109)
state: California
city: O'Fallon
country: United States
facility: Cancer Care Specialists of Illinois ( Site 0152)
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology ( Site 0149)
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Cancer Center ( Site 0108)
state: Kansas
city: Kansas City
country: United States
facility: Truman Medical Center ( Site 0122)
state: Missouri
city: Las Vegas
country: United States
facility: OptumCare Cancer Care ( Site 0121)
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada ( Site 0113)
state: Nevada
city: Albany
country: United States
facility: New York Oncology Hematology, P.C. ( Site 0129)
state: New York
city: Knoxville
country: United States
facility: The University of Tennessee Medical Center ( Site 0142)
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center ( Site 0138)
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute ( Site 0148)
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care ( Site 0132)
state: Virginia
city: Madison
country: United States
facility: SSM Health Dean Medical Group ( Site 0140)
state: Wisconsin
city: Caba.
country: Argentina
facility: Clinica Adventista Belgrano ( Site 0309)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306)
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austral ( Site 0307)
state: Buenos Aires
city: Buenos Aites
country: Argentina
facility: Hospital Aleman ( Site 0301)
state: Caba
city: Rosario.
country: Argentina
facility: Fundacion Estudios Clinicos ( Site 0311)
state: Santa Fe
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires ( Site 0304)
city: San Juan
country: Argentina
facility: Clinica EL Castaño ( Site 0312)
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 1102)
state: Antwerpen
city: Mons
country: Belgium
facility: ASBL CHU Helora - Hôpital de Mons - Site Kennedy ( Site 1103)
state: Hainaut
city: Cascavel
country: Brazil
facility: CEONC ( Site 0412)
state: Parana
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner ( Site 0401)
state: Parana
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer ( Site 0407)
state: Rio Grande Do Norte
city: Florianópolis
country: Brazil
facility: CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0403)
state: Santa Catarina
city: Ribeirao Preto
country: Brazil
facility: Hope ( Site 0413)
state: Sao Paulo
city: Sao Carlos
country: Brazil
facility: Clinica Advanze ( Site 0411)
state: Sao Paulo
city: Sjrp
country: Brazil
facility: F. F. R. M. São Jose do Rio Preto ( Site 0404)
state: Sao Paulo
city: Concepcion.
country: Chile
facility: Biocenter ( Site 0510)
state: Biobio
city: La Serena
country: Chile
facility: IC La Serena Research ( Site 0504)
state: Coquimbo
city: Valdivia
country: Chile
facility: Oncocentro Valdivia ( Site 0506)
state: Los Rios
city: Santiago.
country: Chile
facility: Centro de Estudios Clínicos SAGA ( Site 0508)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: FALP ( Site 0501)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clinica Inmunocel ( Site 0503)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica RedSalud Vitacura ( Site 0512)
state: Region M. De Santiago
city: Vina del mar
country: Chile
facility: Centro de Investigaciones ( Site 0511)
state: Valparaiso
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital ( Site 3124)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 3101)
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital ( Site 3113)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital. ( Site 3119)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 3120)
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center ( Site 3121)
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University ( Site 3122)
state: Guangdong
city: Nanning
country: China
facility: Affiliated Cancer Hospital of Guangxi Medical University ( Site 3123)
state: Guangxi
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University ( Site 3112)
state: Guizhou
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 3125)
state: Hubei
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University ( Site 3117)
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital ( Site 3118)
state: Jiangxi
city: Jinan
country: China
facility: Shandong Cancer Hospital ( Site 3108)
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital ( Site 3106)
state: Shanxi
city: XI An
country: China
facility: 1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 3107)
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Cancer Hospital. ( Site 3111)
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University ( Site 3110)
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hosp CAMS&PUMC ( Site 3105)
state: Tianjin
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital ( Site 3109)
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang Medical University ( Site 3116)
state: Zhejiang
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe ( Site 0604)
state: Antioquia
city: Montería
country: Colombia
facility: IMAT S.A.S ( Site 0603)
state: Cordoba
city: Bogota.
country: Colombia
facility: Hospital Universitario San Ignacio ( Site 0607)
state: Distrito Capital De Bogota
city: Pereira.
country: Colombia
facility: Oncologos del Occidente ( Site 0601)
state: Risaralda
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0602)
state: Valle Del Cauca
city: Aalborg
country: Denmark
facility: Aalborg University Hospital ( Site 1302)
state: Nordjylland
city: Dijon
country: France
facility: CHU Dijon Bourgogne ( Site 1516)
state: Cote-d Or
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1512)
state: Limousin
city: Metz
country: France
facility: Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy ( Site 1515)
state: Moselle
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque ( Site 1513)
state: Nord
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque ( Site 1509)
state: Pyrenees-Atlantiques
city: Toulon
country: France
facility: HIA Sainte Anne ( Site 1506)
state: Var
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon ( Site 1505)
state: Vaucluse
city: La Roche-sur-Yon
country: France
facility: CHD Vendee ( Site 1502)
state: Vendee
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens ( Site 1602)
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko"-Hematology Department ( Site 1603)
state: Attiki
city: Athens
country: Greece
facility: Attikon University General Hospital of Athens ( Site 1604)
state: Attiki
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupoli ( Site 1601)
state: Evros
city: Guatemala.
country: Guatemala
facility: CELAN,S.A ( Site 0702)
city: Guatemala
country: Guatemala
facility: MEDI-K ( Site 0701)
city: Guatemala
country: Guatemala
facility: Cen Integral Onco Gastro y Hemato Onco Guatemala S.A. ( Site 0703)
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital ( Site 3202)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 3201)
city: Haifa
country: Israel
facility: Carmel Hospital ( Site 1903)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 1901)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1904)
city: Tiberias
country: Israel
facility: Poria Medical Center ( Site 1902)
city: Rionero in Vulture
country: Italy
facility: IRCCS Crob ( Site 2002)
state: Potenza
city: Candiolo
country: Italy
facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia ( Site 2010)
state: Torino
city: Ancona
country: Italy
facility: AOU delle Marche Ospedali Riuniti di Ancona ( Site 2011)
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele ( Site 2012)
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia ( Site 2009)
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2004)
city: Palermo
country: Italy
facility: Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 2005)
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci ( Site 2006)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2003)
city: Nagoya
country: Japan
facility: Nagoya University Hospital ( Site 3309)
state: Aichi
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 3321)
state: Ehime
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital ( Site 3318)
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 3308)
state: Ishikawa
city: Isehara
country: Japan
facility: Tokai University Hospital ( Site 3302)
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital ( Site 3301)
state: Miyagi
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 3310)
state: Osaka
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital ( Site 3305)
state: Saitama
city: Bunkyo
country: Japan
facility: Juntendo University Hospital ( Site 3307)
state: Tokyo
city: Chuo
country: Japan
facility: University of Yamanashi Hospital ( Site 3320)
state: Yamanashi
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 3314)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 3313)
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 3322)
city: Kyoto
country: Japan
facility: University Hospital,Kyoto Prefectural University of Medicine ( Site 3315)
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital ( Site 3319)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 3311)
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital ( Site 3317)
city: Yamagata
country: Japan
facility: Yamagata University Hospital ( Site 3312)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center- Center for Hemotologic malignancy ( Site 3806)
state: Kyonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital ( Site 3804)
state: Pusan-Kwangyokshi
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital ( Site 3801)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System ( Site 3802)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 3803)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 3807)
city: Seoul
country: Korea, Republic of
facility: St.Mary's H., Youido ( Site 3805)
city: Kota Kinabalu
country: Malaysia
facility: Queen Elizabeth Hospital ( Site 3405)
state: Sabah
city: Kuching
country: Malaysia
facility: Sarawak General Hospital ( Site 3402)
state: Sarawak
city: Miri
country: Malaysia
facility: Hospital Miri ( Site 3403)
state: Sarawak
city: Petaling Jaya
country: Malaysia
facility: Sunway Medical Centre ( Site 3406)
state: Selangor
city: Ciudad de Mexico
country: Mexico
facility: Centro de Infusion Superare ( Site 0804)
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V. ( Site 0801)
state: Distrito Federal
city: Pachuca
country: Mexico
facility: Grupo Ollin Care ( Site 0806)
state: Hidalgo
city: Morelia
country: Mexico
facility: Centro de Investigacion Clinica Chapultepec ( Site 0803)
state: Michoacan
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 0805)
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum ( Site 2101)
state: Utrecht
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis ( Site 2103)
state: Zuid-Holland
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2201)
state: Mazowieckie
city: Słupsk
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 2210)
state: Pomorskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2208)
state: Slaskie
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice ( Site 2204)
state: Slaskie
city: Olsztyn
country: Poland
facility: Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko ( Site 2205)
state: Warminsko-mazurskie
city: Braga
country: Portugal
facility: Unidade Local de Saude de Braga - Hospital de Braga ( Site 2306)
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2302)
city: Mayaguez
country: Puerto Rico
facility: BRCR Global - Mayaguez ( Site 1003)
city: San Juan
country: Puerto Rico
facility: Auxilio Mutuo Cancer Center ( Site 1001)
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Cluj ( Site 2404)
state: Cluj
city: Sibiu
country: Romania
facility: Spital Judetean Sibiu ( Site 2405)
city: Singapore
country: Singapore
facility: National University Hospital ( Site 3702)
state: Central Singapore
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore ( Site 3701)
state: Central Singapore
city: Cape Town
country: South Africa
facility: Haemalife ( Site 2501)
state: Western Cape
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena ( Site 2608)
state: Andalucia
city: Hospitalet de Llobregat
country: Spain
facility: ICO L Hospitalet ( Site 2601)
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: H. Insular de Gran Canaria ( Site 2606)
state: Las Palmas
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis ( Site 2604)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital del Mar ( Site 2610)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 2611)
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria ( Site 2609)
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet ( Site 2607)
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale Bellinzona e Valli ( Site 2701)
state: Ticino
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 3903)
state: Taoyuan
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 3905)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 3902)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 3901)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 3908)
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital ( Site 3906)
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 4002)
state: Chiang Mai
city: Pathumwan
country: Thailand
facility: Chulalongkorn University ( Site 4003)
state: Krung Thep Maha Nakhon
city: Cherkasy
country: Ukraine
facility: MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2904)
state: Cherkaska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 2906)
state: Ivano-Frankivska Oblast
city: Khmelnytskiy
country: Ukraine
facility: Khmelnytskyi Regional Hospital ( Site 2907)
state: Khmelnytska Oblast
city: Lviv
country: Ukraine
facility: Institute of Blood Pathology and Transfusion Medicine AMS Ukraine ( Site 2903)
state: Lvivska Oblast
city: Kyiv
country: Ukraine
facility: SNPE National Cancer Institute ( Site 2902)
city: Kyiv
country: Ukraine
facility: Universal Clinic Oberig ( Site 2908)
city: Kyiv
country: Ukraine
facility: Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 under the Executive Body of Kyiv City Co ( Site 2905)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: