Clinical trial NCT06047080: An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma
Official title: A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Large B-Cell Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 1130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).


Eligibility criteria: Inclusion Criteria:

* Previously untreated participants with CD20-positive LBCL
* Ability to provide tumor tissue
* International prognostic index (IPI) score 2-5
* Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2
* At least one bi-dimensionally measurable lesion, defined as \> 1.5 cm in its longest dimension as measured by CT or MRI
* Left ventricular ejection fraction (LVEF) \>/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
* Adequate hematologic function
* Negative HIV test at screening with exceptions as defined by the protocol
* Negative SARS-CoV-2 antigen or PCR test

Exclusion Criteria:

* Contraindication to any of the individual components of Pola-R-CHP or glofitamab, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
* Prior solid organ transplantation
* Participants receiving systemic immunosuppressive agent such as, but not limited to cyclosporin, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 4 weeks prior to first dose of study treatment
* Current Grade \> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
* History of indolent lymphoma (e.g., Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstrom macroglobulinemia)
* Current diagnosis of the following: Follicular lymphoma grade 3B; transformations of indolent B-cell lymphomas (e.g., de novo transformed follicular lymphoma); mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; primary large B-cell lymphoma of immune-privileged sites (encompassing primary diffuse large B-cell lymphoma of the CNS, primary large B-cell lymphoma of the vitreoretina and primary large B-cell lymphoma of the testis); primary effusion DLBCL; and primary cutaneous DLBCL, leg type
* Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
* Prior treatment with systemic immunotherapeutic agents
* Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1
* Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1
* Prior radiotherapy to the mediastinal/pericardial region
* Prior therapy for LBCL, with the exception of corticosteriods
* Corticosteroid use \> 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
* History of other malignant or non-malignant diseases that could affect compliance with the protocol or interpretation of results
* Significant or extensive history of cardiovascular disease
* Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
* Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* Known or suspected chronic active Epstein-Barr viral infection
* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
* Active autoimmune disease requiring treatment
* Clinically significant liver disease
* Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover are prohibited
* Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
* Suspected active or latent tuberculosis
* Positive test results for chronic hepatitis B infection, hepatitis C, or the human T-lymphotropic virus type 1 (HTLV-1)
* History of progressive multifocal leukoencephalopathy

Primary outcomes:
measure: Progression-free survival (PFS) as determined by Independent Review Facility (IRF)
timeFrame: From randomization to the first occurrence of disease progression or relapse, or death due to any cause, whichever occurs first (up to approximately 65 months)
Secondary outcomes:
measure: PFS as determined by the investigator
timeFrame: From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 65 months)
measure: PFS as determined by the investigator and IRF for participants with international prognostic index (IPI) 3-5
timeFrame: From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to 65 months)
measure: Event-free survival efficacy causes (EFSeff)
timeFrame: From randomization to the earliest occurrence of disease progression or relapse; death due to any cause; initiation of new anti-lymphoma treatment; or positive biopsy for residual disease after treatment completion (up to approximately 65 months)
measure: Complete response (CR) rate
timeFrame: At the end of treatment (up to approximately 65 months)
measure: Objective response rate (ORR)
timeFrame: At treatment completion or discontinuation (up to approximately 65 months)
measure: Overall survival (OS)
timeFrame: From randomization to death from any cause (up to approximately 65 months)
measure: Duration of response (DOR)
timeFrame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 65 months)
measure: Duration of complete response (DOCR)
timeFrame: From the first occurrence of a documented complete response (CR) to disease progression or death, whichever occurs first (up to approximately 65 months)
measure: Disease-free survival (DFS)
timeFrame: From a documented CR at the end of treatment to disease progression or death, whichever occurs first (up to approximately 65 months)
measure: Serum concentration of glofitamab
timeFrame: Up to approximately 65 months
measure: Incidence of anti-drug antibodies (ADAs)
timeFrame: Baseline up to approximately 65 months
measure: Proportion of participants experiencing a clinically meaningful improvement in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)
timeFrame: Up to approximately 65 months
measure: Time to deterioration in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)
timeFrame: Up to approximately 65 months
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: From randomization to the end of study (up to approximately 65 months)
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Oncology & Hematology, LLC
state: Alaska
city: Anaheim
country: United States
facility: Kaiser Permanente - Anaheim (E. La Palma)
state: California
city: Clovis
country: United States
facility: University of California, San Francisco-Fresno
state: California
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Irvine
country: United States
facility: City of Hope - Lennar Foundation Cancer Center
state: California
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines
state: California
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Los Angeles
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center
state: California
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland
state: California
city: Roseville
country: United States
facility: Kaiser Permanente - Roseville
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco (2238 Geary)
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente - Santa Clara
state: California
city: Stanford
country: United States
facility: Stanford Univ School of Med
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Ctr
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente - Walnut Creek
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Center - Denver
state: Colorado
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Washington
country: United States
facility: Medstar Franklin Square Medical Center
state: District of Columbia
city: Miami
country: United States
facility: Miami Cancer Institute of Baptist Health, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute at Memorial West
state: Florida
city: Honolulu
country: United States
facility: Hawaii Cancer Care
state: Hawaii
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
state: Illinois
city: Evanston
country: United States
facility: NorthShore Center for Advanced Imaging
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Wichita
country: United States
facility: Ascension Via Christi Research
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center
state: Minnesota
city: Chesterfield
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Basking Ridge
country: United States
facility: MSKCC at Basking Ridge
state: New Jersey
city: East Brunswick
country: United States
facility: Astera Cancer Care East Brunswick
state: New Jersey
city: Middletown
country: United States
facility: MSK Monmouth
state: New Jersey
city: Montvale
country: United States
facility: MSK Bergen
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center - Montefiore Medical Park
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Bronx
country: United States
facility: New York Cancer & Blood Specialists
state: New York
city: Brooklyn
country: United States
facility: NYU Langone Hospital?Brooklyn
state: New York
city: Commack
country: United States
facility: MSK Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Mineola
country: United States
facility: NYU Long Island Hospital
state: New York
city: New Hyde Park
country: United States
facility: New York Cancer and Blood Specialists - New Hyde Park
state: New York
city: New York
country: United States
facility: New York University Medical Center PRIME
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College-New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: New York Cancer and Blood Specialists-Central Park Hematology & Oncology
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Shirley
country: United States
facility: North Shore Hematology Oncology Association PC
state: New York
city: Uniondale
country: United States
facility: MSK Nassau
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc - Cincinnati - USOR
state: Ohio
city: Springfield
country: United States
facility: Willamette Valley Cancer Insitute and Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Kimmel Cancer Center Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Hospital
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Chattanooga
country: United States
facility: Greco-Hainesworth Tennessee Oncology Centers for Research
state: Tennessee
city: Germantown
country: United States
facility: West Cancer Center & Research Institute
state: Tennessee
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology
state: Texas
city: Houston
country: United States
facility: Harris Health System Smith Clinic
state: Texas
city: Houston
country: United States
facility: O'Quinn Medical Tower at McNair Campus
state: Texas
city: San Antonio
country: United States
facility: USOR - Texas Oncology - San Antonio Northeast
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Edmonds
country: United States
facility: Swedish Cancer Institute - Edmonds Campus
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington - Seattle Cancer Care Alliance
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Madison
country: United States
facility: Univ of Wisconsin Hosp & Clin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
city: Buenos Aires
country: Argentina
facility: FUNDALEU
city: Buenos Aires
country: Argentina
facility: Hospital Aleman de Buenos Aires
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: Pilar
country: Argentina
facility: Hospital Austral
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital- Department of Hematology
state: New South Wales
city: Douglas
country: Australia
facility: Townsville Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital Woolloongabba
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Box Hill
country: Australia
facility: Eastern Health
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Centre
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Brussel
country: Belgium
facility: UZ Brussel
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Paraná
city: Sao Paulo
country: Brazil
facility: Instituto D'Or Pesquisa e Ensino
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP, Oncologia
state: São Paulo
city: St. John's
country: Canada
facility: Eastern Health - General Hospital
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health Centre - Brampton Civic Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Quebec City
country: Canada
facility: CHA Hopital de I enfant-Jesus
state: Quebec
city: Trois-rivieres
country: Canada
facility: Centre Integre Universitaire de Sante et de Services Sociaux de la Mauricie-et-du-Centre-du-Quebec
state: Quebec
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changchun City
country: China
facility: The First Hospital of Jilin University
city: Changsha CITY
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chongqing
country: China
facility: Second Affiliated Hospital of Third Military Medical University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangdong Province Guangzhou City
country: China
facility: Southern Medical University Nanfang Hospital
city: Guangzhou
country: China
facility: Sun yat-sen University Cancer Center
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei City
country: China
facility: Anhui Province Cancer Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Nanchang City
country: China
facility: Jiangxi Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Nanning
country: China
facility: Guangxi Cancer Hospital of Guangxi Medical University
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Shenyang City
country: China
facility: Shengjing Hospital of China Medical University
city: Shenyang
country: China
facility: First Hospital of China Medical University
city: Suzhou
country: China
facility: First Affiliated Hospital of Soochow University
city: Tianjin City
country: China
facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Wuhan City
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuhan City
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital Skejby
city: Herning
country: Denmark
facility: Regionshospitalet Gødstrup
city: Lille
country: France
facility: CHRU de Lille - Hopital Claude Huriez
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU de Nantes - Hotel Dieu
city: Pessac
country: France
facility: CHU de Bordeaux
city: Rennes
country: France
facility: CHU DE RENNES - CHU Pontchaillou
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Strasbourg
country: France
facility: CHU Strasbourg Hpital Hautepierre
city: Toulouse
country: France
facility: IUCT Oncopole
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Brandenburg an der Havel
country: Germany
facility: Staedisches Klinikum Brandenburg
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Medizinische Klinik 5, Hämatologie und Internistische Onkologie
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: UKE Universitätsklinikum Hamburg-Eppendorf
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum GmbH
city: Kiel
country: Germany
facility: Städtisches Krankenhaus Kiel GmbH
city: Koeln
country: Germany
facility: Universitätsklinikum Köln
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig Holstein - Campus Luebeck
city: Magdeburg
country: Germany
facility: Otto von Guericke Uni Magdeburg Uniklinik
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München, III. Medizinische Klinik
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergman
city: Rostock
country: Germany
facility: Universitaet Rostock, Zentrum Innere Medizin
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart Katharinenhospital
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale
state: Campania
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena
state: Emilia-Romagna
city: Genova
country: Italy
facility: A.O. Universitaria S. Martino Di Genova
state: Liguria
city: Bergamo
country: Italy
facility: Asst Papa Giovanni Xxiii
state: Lombardia
city: Milano
country: Italy
facility: Fond. IRCCS Istituto Nazionale Tumori
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Catania
country: Italy
facility: A. O. U. Policlinico G. Rodolico
state: Sicilia
city: Prato
country: Italy
facility: USL 4 di Prato - Nuovo Ospeale di Prato
state: Toscana
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
state: Veneto
city: Aichi
country: Japan
facility: Anjo Kosei Hospital
city: Aichi
country: Japan
facility: Aichi Cancer Center
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Miyagi
country: Japan
facility: Tohoku University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Osaka
country: Japan
facility: Kansai Medical University Hospital
city: Osaka
country: Japan
facility: Kindai University Hospital
city: Shimane
country: Japan
facility: Shimane University Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: Komagome Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Busan
country: Korea, Republic of
facility: Inje university Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yeouido St. Mary's Hospital
city: Cdmx
country: Mexico
facility: Health Pharma Professional Research
state: Mexico CITY (federal District)
city: Mexico City
country: Mexico
facility: Inst. Nacional de Cancerologia
state: Mexico CITY (federal District)
city: Mexico
country: Mexico
facility: Hospital General de Mexico
state: Tlaxcala
city: Mexico City
country: Mexico
facility: Hospital de Especialidades Centro Medico Nacional La Raza
city: Brzozów
country: Poland
facility: Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
city: Gda?sk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
city: Kielce
country: Poland
facility: ?wi?tokrzyskie Centrum Onkologii SPZOZ
city: Kraków
country: Poland
facility: PRATIA MCM Kraków
city: Wroc?aw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
city: San Juan
country: Puerto Rico
facility: Auxilio Mutuo Cancer Center
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS)
state: LA Coruna
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra Madrid
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Chai Yi
country: Taiwan
facility: Chang Gung Medical Foundation - Chai Yi
city: Kaoisung
country: Taiwan
facility: Chang Gung Medical Foundation - Kaohsiung;Oncology
city: Kaoshiung
country: Taiwan
facility: E-Da Cancer Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: Chi-Mei Hospital, Liouying
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Ankara
country: Turkey
facility: Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul VKV American Hospital
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
city: Izmit
country: Turkey
facility: Kocaeli Univesity Medical Faculty
city: Barnet
country: United Kingdom
facility: Barnet Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation Trust
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hosp NHS Trust
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust - University College Hospital
city: London
country: United Kingdom
facility: Guy'S Hospital
city: Newcastle
country: United Kingdom
facility: Newcastle University
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital - Oxford Cancer & Haematology Centre
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: