Clinical trial NCT05578976: A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Official title: A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Non-Hodgkins Lymphoma
Cancer
Epcoritamab
ABBV-GMAB-3013
R-CHOP
Rituximab
EPCORE
Lead sponsor: Genmab
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.

In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.


Eligibility criteria: Inclusion Criteria:

* Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
* Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma \[DLBCL\] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:

  * DLBCL, Not Otherwise Specified (NOS).
  * High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
  * T-cell/histiocyte-rich large B-cell lymphoma.
  * Epstein Barr virus-positive DLBCL, NOS.
  * Follicular lymphoma Grade 3b.

Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.

Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.

* Availability of archival or fresh or paraffin embedded tissue at Screening.
* Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status \>= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
* Has at least one target lesion defined as:

  * \>= 1 measurable nodal lesion (long axis \> 1.5 cm ) or \>= 1 measurable extra-nodal lesion (long axis \> 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
  * Positron emission tomography (PET)-positive on PET-CT scan.
* Laboratory values meeting the criteria laid out in the protocol.
* Left ventricular ejection fraction must be \>= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.

Exclusion Criteria:

* History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent\] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
* Clinically significant cardiovascular disease as per the protocol.

Primary outcomes:
measure: Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5
timeFrame: Up to Approximately 46 Months
Secondary outcomes:
measure: Number of Participants with PFS
timeFrame: Up to Approximately 46 Months
measure: Number of Participants with Event-free survival (EFS)
timeFrame: Up to Approximately 46 Months
measure: Percentage of Participants with Complete Remission (CR)
timeFrame: On or After to Approximately 28 Weeks
measure: Overall survival (OS)
timeFrame: Up to Approximately 76 Months
measure: Percentage of Participants with Minimal Residual Disease (MRD) Negativity
timeFrame: Up to Approximately 46 Months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center - North Campus /ID# 227463
state: Arizona
city: Yuma
country: United States
facility: Yuma Regional Medical Center /ID# 261527
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences /ID# 225703
state: Arkansas
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc. /ID# 262037
state: California
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center for Research /ID# 229427
state: California
city: Fountain Valley
country: United States
facility: Orange Coast Memorial Medical Center /ID# 229632
state: California
city: Fullerton
country: United States
facility: Providence - St. Jude Medical Center /ID# 262042
state: California
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center /ID# 229631
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Ct /ID# 228996
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Speciality Clinic - Los Alamitos /ID# 262032
state: California
city: Los Angeles
country: United States
facility: University of Southern California /ID# 225443
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 226887
state: California
city: Aurora
country: United States
facility: Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228618
state: Colorado
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida /ID# 226826
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Florida Cancer Affiliates - Main /ID# 262785
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute /ID# 232626
state: Florida
city: Honolulu
country: United States
facility: Straub Medical Center /ID# 229464
state: Hawaii
city: Chicago
country: United States
facility: University of Illinois at Chicago /ID# 226889
state: Illinois
city: Springfield
country: United States
facility: Southern IL Univ School of Med /ID# 228999
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic Main Campus /ID# 262584
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Institute /ID# 228338
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Comprehensive Cancer Center /ID# 227026
state: Indiana
city: Goshen
country: United States
facility: Goshen Center for Cancer Care /ID# 225534
state: Indiana
city: Des Moines
country: United States
facility: University of Iowa Health Care /ID# 261945
state: Iowa
city: Wichita
country: United States
facility: Cancer Center of Kansas /ID# 261983
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute - St. Matthews /ID# 225420
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland, Baltimore /ID# 225421
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital /ID# 225369
state: Maryland
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland /ID# 226859
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Medical Center /ID# 226939
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 225462
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health St. Joseph Mercy Ann Arbor /ID# 228206
state: Michigan
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 226680
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center /ID# 228045
state: Mississippi
city: Billings
country: United States
facility: Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 259014
state: Montana
city: Lincoln
country: United States
facility: NHO Revive Research Institute, LLC /ID# 261113
state: Nebraska
city: Camden
country: United States
facility: MDACC Cooper /ID# 260320
state: New Jersey
city: East Brunswick
country: United States
facility: Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 226654
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center /ID# 239457
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico /ID# 227332
state: New Mexico
city: Albuquerque
country: United States
facility: Presbyterian Kaseman Hospital /ID# 262084
state: New Mexico
city: Rio Rancho
country: United States
facility: Presbyterian Rust Medical Center /ID# 262068
state: New Mexico
city: Bronx
country: United States
facility: New York Cancer and Blood Specialists- Eastchester, Bronx /ID# 265396
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute /ID# 239127
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island /ID# 262412
state: New York
city: New Hyde Park
country: United States
facility: New York Cancer and Blood Specialists- New Hyde Park /ID# 265392
state: New York
city: New York
country: United States
facility: NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 226141
state: New York
city: New York
country: United States
facility: New York Cancer and Blood Specialists- Manhattan /ID# 265391
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai /ID# 225370
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 225379
state: New York
city: Port Jefferson Station
country: United States
facility: New York Cancer and Blood Specialists /ID# 261114
state: New York
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center /ID# 227753
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University - Brody School of Medicine /ID# 225992
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center /ID# 228339
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 225374
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Arthur G.H. Bing, MD Cancer Center /ID# 260790
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma, Stephenson Cancer Center /ID# 225556
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente - Northwest /ID# 225488
state: Oregon
city: Houston
country: United States
facility: Houston Methodist Hospital /ID# 258957
state: Texas
city: Kingwood
country: United States
facility: Millennium Research & Clinical Development /ID# 228284
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research /ID# 227217
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center- Temple /ID# 225935
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center /ID# 231184
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center - West Complex /ID# 225433
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 225796
state: Virginia
city: Olympia
country: United States
facility: Vista Oncology - East Olympia /ID# 229375
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation /ID# 225432
state: Washington
city: Tacoma
country: United States
facility: MultiCare Regional Cancer Center - Tacoma /ID# 265285
state: Washington
city: Liverpool
country: Australia
facility: Liverpool Hospital /ID# 230072
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 225683
state: South Australia
city: Clayton
country: Australia
facility: Monash Health - Monash Medical Centre /ID# 225680
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health /ID# 225716
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital /ID# 225999
state: Victoria
city: Nedlands
country: Australia
facility: Hollywood Private Hospital /ID# 251837
state: Western Australia
city: Nedlands
country: Australia
facility: Perth Blood Institute Ltd /ID# 225679
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital /ID# 226583
state: Western Australia
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum St. Poelten /ID# 234016
state: Niederoesterreich
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 252095
state: Wien
city: Vienna
country: Austria
facility: Klinik Ottakring /ID# 243941
state: Wien
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228360
city: Antwerp
country: Belgium
facility: Duplicate_ZAS Middelheim /ID# 225741
state: Antwerpen
city: Antwerp
country: Belgium
facility: ZAS Cadix /ID# 264327
state: Antwerpen
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 225737
state: Bruxelles-Capitale
city: La Louvière
country: Belgium
facility: Hospital La Louviere Site Jolimont - Helora /ID# 225738
state: Hainaut
city: Liège
country: Belgium
facility: CHU de Liège /ID# 225952
state: Liege
city: Yvoir
country: Belgium
facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 225742
state: Namur
city: Gent
country: Belgium
facility: UZ Gent /ID# 250031
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: Vitaz /Id# 226153
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 225951
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ-Delta /ID# 225736
state: West-Vlaanderen
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet /ID# 225954
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 225735
city: Curitiba
country: Brazil
facility: Hospital de Clinicas da Universidade Federal do Parana /ID# 226027
state: Parana
city: Jaú
country: Brazil
facility: Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 252832
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer (INCA) /ID# 226026
city: Sao Paulo
country: Brazil
facility: Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz /ID# 252833
city: Sao Paulo
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 262394
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 226048
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi /ID# 245780
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski /ID# 244615
city: Sofia
country: Bulgaria
facility: SHAT Hematologic Diseases /ID# 250102
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre Pharmacy /ID# 226077
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver /ID# 230573
state: British Columbia
city: Brampton
country: Canada
facility: William Osler Health System /ID# 250973
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre /ID# 226084
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre /ID# 226082
state: Saskatchewan
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital /ID# 230941
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital /ID# 229819
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 230975
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital /ID# 238430
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University /ID# 238426
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center /ID# 238371
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital /ID# 230945
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 238436
state: Guangdong
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University /ID# 238656
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital /Id# 241755
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital /ID# 230398
state: Henan
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234152
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital /ID# 232256
state: Hubei
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University /ID# 232569
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College /ID# 233174
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University /ID# 230399
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital /ID# 233379
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University /ID# 239618
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University /ID# 233201
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital /ID# 233200
state: Shandong
city: Shanghai
country: China
facility: Fudan University Cancer Hospital /ID# 251516
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital /ID# 250745
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Cancer Hospital /ID# 230974
state: Tianjin
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 259904
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230387
state: Zhejiang
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University school of medicine /ID# 231249
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer hospital /ID# 231388
state: Zhejiang
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava /ID# 251809
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicka bolnica Merkur /ID# 252481
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb /ID# 250709
state: Grad Zagreb
city: Rijeka
country: Croatia
facility: Klinicki bolnicki centar Rijeka /ID# 251811
state: Primorsko-goranska Zupanija
city: Split
country: Croatia
facility: Klinicki Bolnicki Centar (KBC) Split /ID# 250729
state: Splitsko-dalmatinska Zupanija
city: Slavonski Brod
country: Croatia
facility: Opca bolnica Dr. Josip Bencevic /ID# 251812
city: Brno
country: Czechia
facility: Fakultní Nemocnice Brno - Jihlavská /ID# 225953
state: Brno-mesto
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové - Sokolská /ID# 225955
state: Hradec Kralove
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava /ID# 225957
state: Ostrava-mesto
city: Prague
country: Czechia
facility: Duplicate_Fakultni Nemocnice v Motole /ID# 225958
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady /ID# 225956
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze /ID# 225396
city: Copenhagen Ø
country: Denmark
facility: Rigshospitalet /ID# 226576
state: Hovedstaden
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital - Skejby /ID# 226594
state: Midtjylland
city: Roskilde
country: Denmark
facility: Roskilde Sygehus /ID# 226597
state: Sjælland
city: Odense
country: Denmark
facility: Odense University Hospital /ID# 226593
state: Syddanmark
city: Vejle
country: Denmark
facility: Sygehus Lillebalt, Vejle /ID# 226592
state: Syddanmark
city: Nice
country: France
facility: CHU de Nice - Hôpital Archet 1 /ID# 226127
state: Alpes-Maritimes
city: Clermont
country: France
facility: CHU Clermont-Ferrand /ID# 229283
state: Auvergne-Rhone-Alpes
city: Marseille
country: France
facility: Institut Paoli-Calmettes /ID# 226557
state: Bouches-du-Rhone
city: Rennes
country: France
facility: CHU de Rennes - PONTCHAILLOU /ID# 228207
state: Bretagne
city: Dijon
country: France
facility: CHU Dijon /ID# 238345
state: Cote-d Or
city: Limoges CEDEX 1
country: France
facility: CHU Limoges - Dupuytren 1 /ID# 234235
state: Franche-Comte
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hopital Saint Eloi /ID# 228191
state: Herault
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 238343
state: Ile-de-France
city: La Tronche
country: France
facility: CHU Grenoble - Hopital Michallon /ID# 226128
state: Isere
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU Nancy - Hopitaux de Brabois /ID# 226102
state: Meurthe-et-Moselle
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 226101
state: Nord
city: Creteil
country: France
facility: Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 226560
state: Paris
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 226125
state: Pays-de-la-Loire
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque /ID# 249143
state: Pyrenees-Atlantiques
city: Pierre Benite CEDEX
country: France
facility: HCL - Hopital Lyon Sud /ID# 227086
state: Rhone
city: Rouen
country: France
facility: Centre Henri Becquerel /ID# 226103
state: Seine-Maritime
city: Amiens CEDEX 1
country: France
facility: CHU Amiens-Picardie Site Sud /ID# 238347
state: Somme
city: La Roche Sur Yon
country: France
facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 243899
state: Vendee
city: Poitiers
country: France
facility: CHU Poitiers - La miletrie /ID# 226578
state: Vienne
city: Angers
country: France
facility: Chu Angers /Id# 245931
city: Caen
country: France
facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582
city: Paris
country: France
facility: Hôpital Saint-Louis /ID# 226126
city: Saint-cloud
country: France
facility: Institut Curie - site CLCC René Huguenin /ID# 253519
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 225399
state: Attiki
city: Athens
country: Greece
facility: Alexandra General Hospital /ID# 225402
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 225401
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina /ID# 225400
city: Thessaloniki
country: Greece
facility: General University Hospital of Thessaloniki AXEPA /ID# 225398
city: Thessaloniki
country: Greece
facility: Theageneio Anticancer Hospital /ID# 225516
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 257189
state: Gyor-Moson-Sopron
city: Debrecen
country: Hungary
facility: Debreceni Egyetem-Klinikai Kozpont /ID# 226821
state: Hajdu-Bihar
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245938
state: Somogy
city: Szekszard
country: Hungary
facility: Tolna Varmegyei Balassa Janos Korhaz /ID# 250063
state: Tolna
city: Szombathely
country: Hungary
facility: Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 226846
state: Vas
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 227239
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet /ID# 227294
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem /ID# 226838
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 225981
state: H_efa
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 225612
state: HaMerkaz
city: Tel Aviv
country: Israel
facility: Assuta Tel Aviv Medical Center /ID# 226066
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 225600
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 225891
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 259796
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah /ID# 225614
state: Yerushalayim
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 225862
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 225551
state: Emilia-Romagna
city: San Giovanni Rotondo
country: Italy
facility: Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 225554
state: Foggia
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele /ID# 225555
state: Milano
city: Milan
country: Italy
facility: Istituto Europeo Di Oncologia /ID# 225545
state: Milano
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 225543
state: Napoli
city: Torino
country: Italy
facility: A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 225775
state: Piemonte
city: Aviano
country: Italy
facility: Duplicate_Centro di Riferimento Oncologico /ID# 225553
state: Pordenone
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 252192
state: Reggio Emilia
city: Candiolo
country: Italy
facility: Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 225751
state: Torino
city: Alessandria
country: Italy
facility: Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Aless /ID# 225542
city: Bari
country: Italy
facility: I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 225548
city: Brescia
country: Italy
facility: Duplicate_ASST Spedali civili di Brescia /ID# 225549
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 225541
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana /ID# 225575
city: Ravenna
country: Italy
facility: Ospedale Santa Maria Delle Croci /ID# 225571
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 230677
state: Aichi
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital /ID# 226090
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 250151
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital /ID# 251068
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center /ID# 251622
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 226091
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 250869
state: Fukushima
city: Sapporo-shi
country: Japan
facility: Duplicate_Hokkaido University Hospital /ID# 250149
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital /ID# 250597
state: Hyogo
city: Tsukuba-shi
country: Japan
facility: University of Tsukuba Hospital /ID# 251282
state: Ibaraki
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital /ID# 251770
state: Ishikawa
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Hospital /ID# 250163
state: Kagoshima
city: Isehara
country: Japan
facility: Tokai University Hospital /ID# 251281
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 250150
state: Miyagi
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 250161
state: Okayama
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 250160
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 251283
state: Osaka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 226089
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR /ID# 230269
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 230003
state: Yamagata
city: Busan
country: Korea, Republic of
facility: Inje University - Busan Paik Hospital /ID# 232262
state: Busan Gwang Yeogsi
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 225763
state: Gyeonggido
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital /ID# 232264
state: Gyeongsangbugdo
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center /ID# 228451
state: Gyeongsangnamdo
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital /ID# 232263
state: Jeonrabugdo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 225760
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 225758
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 225759
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 225761
state: Seoul Teugbyeolsi
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital /ID# 226971
state: Ulsan Gwang Yeogsi
city: Almere
country: Netherlands
facility: Flevo Ziekenhuis /ID# 229606
state: Flevoland
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden /ID# 225605
state: Friesland
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen /ID# 229762
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis /ID# 231291
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum /ID# 225607
state: Limburg
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis /ID# 229550
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis /ID# 230465
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum /ID# 225603
state: Noord-Brabant
city: Tilburg
country: Netherlands
facility: Elisabeth Tweesteden Ziekenhuis /ID# 229773
state: Noord-Brabant
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep /ID# 230613
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum /ID# 225608
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Olvg /Id# 229761
state: Noord-Holland
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis, Haarlem Zuid /ID# 229621
state: Noord-Holland
city: Hilversum
country: Netherlands
facility: Tergooi /ID# 229772
state: Noord-Holland
city: Hoorn Nh
country: Netherlands
facility: Dijklander Ziekenhuis /ID# 229900
state: Noord-Holland
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum /ID# 230614
state: Noord-Holland
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente /ID# 225610
state: Overijssel
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum /ID# 229608
state: Utrecht
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis /ID# 229901
state: Utrecht
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis /ID# 229560
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum /ID# 225606
state: Zuid-Holland
city: Den Haag
country: Netherlands
facility: Haaglanden Medisch Centrum /ID# 229686
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis /ID# 229937
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 225602
city: S Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis /ID# 229765
city: Utrecht
country: Netherlands
facility: Diakonessenhuis /ID# 251793
city: Takapuna
country: New Zealand
facility: North Shore Hospital /ID# 250992
state: Auckland
city: Christchurch
country: New Zealand
facility: Christchurch Hospital /ID# 250993
state: Canterbury
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723
state: Pomorskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 225986
state: Swietokrzyskie
city: Olsztyn
country: Poland
facility: Szpital Kliniczny MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985
state: Warminsko-mazurskie
city: Pila
country: Poland
facility: ARS-MEDICAL Sp. z o.o. /ID# 225848
state: Wielkopolskie
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan /ID# 227236
state: Wielkopolskie
city: Braga
country: Portugal
facility: 2CA-Braga, Hospital de Braga /ID# 249112
city: Lisboa
country: Portugal
facility: IPO Lisboa FG, EPE /ID# 249109
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE /ID# 249111
city: Porto
country: Portugal
facility: IPO Porto FG, EPE /ID# 249110
city: Curitiba
country: Puerto Rico
facility: Hospital Erasto Gaertner /ID# 262593
city: Manati
country: Puerto Rico
facility: Hematology and Oncology Institute /ID# 230054
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials, LLC /ID# 230052
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav /ID# 238847
state: Bratislavsky Kraj
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin /ID# 240828
state: Zilinsky Kraj
city: Johannesburg
country: South Africa
facility: Wits Clinical Research /ID# 227799
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits Clinical Research /ID# 227803
state: Gauteng
city: Pretoria
country: South Africa
facility: Alberts Cellular Therapy /ID# 227798
state: Gauteng
city: Cape Town
country: South Africa
facility: University of Cape Town /ID# 227802
state: Western Cape
city: Kuilsrivier
country: South Africa
facility: Haemalife Inc. /ID# 243391
state: Western Cape
city: Badalona
country: Spain
facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 228063
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 227393
state: Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia /ID# 225806
state: Cordoba
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 255381
state: Murcia
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona /ID# 225809
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Parc de Salut del Mar /ID# 225810
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 225811
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 226651
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 225813
city: Madrid
country: Spain
facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor /ID# 225816
city: Madrid
country: Spain
facility: MD Anderson Madrid /ID# 225817
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 241750
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 225804
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 225815
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 225818
city: Linkoping
country: Sweden
facility: Linkoping University Hospital /ID# 233521
state: Ostergotlands Lan
city: Lund
country: Sweden
facility: Skane University Hospital Lund /ID# 227285
state: Skane Lan
city: Solna
country: Sweden
facility: Karolinska University Hospital Solna /ID# 229284
state: Stockholms Lan
city: Boras
country: Sweden
facility: Sodra Alvsborgs sjukhus /ID# 228885
state: Vastra Gotalands Lan
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset /ID# 250089
state: Vastra Gotalands Lan
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau AG /ID# 229112
state: Aargau
city: Thun
country: Switzerland
facility: Spital Thun /ID# 229499
state: Bern
city: Winterthur
country: Switzerland
facility: KSW Kantonsspital Winterthur /ID# 241631
state: Zuerich
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 226670
state: Kaohsiung
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 226188
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital /ID# 226674
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 226671
city: Dilovası
country: Turkey
facility: Anadolu Saglik Merkezi /ID# 225777
state: Kocaeli
city: Ankara
country: Turkey
facility: Ankara Universitesi Fakultesi /ID# 227331
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty /ID# 226572
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi /ID# 251247
city: Trabzon
country: Turkey
facility: Karadeniz University /ID# 226573
city: Yuregir
country: Turkey
facility: Baskent Universitesi Adana Uyg. ve Arast. Merkezi Yuregir Baskent Hastanesi /ID# 225921
city: London
country: United Kingdom
facility: Hammersmith Hospital /ID# 242215
state: England
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 226692
state: Norfolk
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 229197
city: Edinburgh
country: United Kingdom
facility: NHS Lothian /ID# 229055
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: