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)

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified December 2024 by Genmab
Sponsor
Genmab
Information Provided by (Responsible Party)
Genmab
Clinicaltrials.gov Identifier
NCT05578976
Other Study ID Numbers:
M20-621
First Submitted
October 11, 2022
First Posted
October 12, 2022
Last Update Posted
January 22, 2025
Last Verified
December 2024

ClinicalTrials.gov processed this data on January 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Diffuse Large B-Cell Lymphoma
Drug: EpcoritamabDrug: Cyclophosphamide

Study Design

Study TypeInterventional
Actual Enrollment900 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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 Start DateFebruary 7, 2023
Actual Primary Completion Date1yr 3w from now
Actual Study Completion Date3yrs 6mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Epcoritamab and R-CHOP
Participants will receive subcutaneous epcoritamab combined with intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.
Drug: Epcoritamab
Subcutaneous Injection (SC)
R-CHOP and Rituximab
Participants will receive intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by intravenous rituximab in 21-day cycles.
Drug: Cyclophosphamide
Intravenous (IV) Injection

Outcome Measures

Primary Outcome Measures
  1. Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5
    PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC), or death due to any cause whichever comes first.
Secondary Outcome Measures
  1. Number of Participants with PFS
    PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by IRC, or death due to any cause, whichever occurs first.
  2. Number of Participants with Event-free survival (EFS)
    EFS is defined as the duration from randomization to the date of disease progression determined by Lugano criteria as assessed by IRC, IRC-assessed PR or SD followed by non protocol-specified NALT, a positive biopsy on or after end-of-treatment (EOT), regardless of whether NAL initiated, or death from any cause.
  3. Percentage of Participants with Complete Remission (CR)
    CR on or after EOT, determined by Lugano 2014 criteria as assessed by IRC.
  4. Overall survival (OS)
    OS is defined as time from randomization until death due to any causes.
  5. Percentage of Participants with Minimal Residual Disease (MRD) Negativity
    The MRD negativity rate is defined as the percentage of participants who achieve MRD negativity prior to the initiation of any non-protocol-specified new anti-lymphoma therapy.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsGenmab
Locations
University of Arizona Cancer Center - North Campus /ID# 227463 | Tucson Arizona, United States, 85719-1478Yuma Regional Medical Center /ID# 261527 | Yuma Arizona, United States, 85364University of Arkansas for Medical Sciences /ID# 225703 | Little Rock Arkansas, United States, 72205CBCC Global Research, Inc. /ID# 262037 | Bakersfield California, United States, 93309Alta Bates Summit Medical Center for Research /ID# 229427 | Berkeley California, United States, 94705Orange Coast Memorial Medical Center /ID# 229632 | Fountain Valley California, United States, 92708Providence - St. Jude Medical Center /ID# 262042 | Fullerton California, United States, 92835Saddleback Memorial Medical Center /ID# 229631 | Laguna Hills California, United States, 92653-3689Long Beach Memorial Medical Ct /ID# 228996 | Long Beach California, United States, 90806-1701Cancer and Blood Speciality Clinic - Los Alamitos /ID# 262032 | Los Alamitos California, United States, 90720-3309University of Southern California /ID# 225443 | Los Angeles California, United States, 90033University of California, Los Angeles /ID# 226887 | Los Angeles California, United States, 90095Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228618 | Aurora Colorado, United States, 80014Cancer Specialists of North Florida /ID# 226826 | Jacksonville Florida, United States, 32256Ocala Oncology Florida Cancer Affiliates - Main /ID# 262785 | Ocala Florida, United States, 34474-4445Orlando Health Cancer Institute /ID# 232626 | Orlando Florida, United States, 32806Straub Medical Center /ID# 229464 | Honolulu Hawaii, United States, 96813-3097University of Illinois at Chicago /ID# 226889 | Chicago Illinois, United States, 60607Southern IL Univ School of Med /ID# 228999 | Springfield Illinois, United States, 62702Springfield Clinic Main Campus /ID# 262584 | Springfield Illinois, United States, 62703-2403Carle Cancer Institute /ID# 228338 | Urbana Illinois, United States, 61801-1645Parkview Comprehensive Cancer Center /ID# 227026 | Fort Wayne Indiana, United States, 46845Goshen Center for Cancer Care /ID# 225534 | Goshen Indiana, United States, 46526University of Iowa Health Care /ID# 261945 | Des Moines Iowa, United States, 50314-3017Cancer Center of Kansas /ID# 261983 | Wichita Kansas, United States, 67214Norton Cancer Institute - St. Matthews /ID# 225420 | Louisville Kentucky, United States, 40207University of Maryland, Baltimore /ID# 225421 | Baltimore Maryland, United States, 21201Johns Hopkins Hospital /ID# 225369 | Baltimore Maryland, United States, 21287American Oncology Partners of Maryland /ID# 226859 | Bethesda Maryland, United States, 20817UMass Memorial Medical Center /ID# 226939 | Worcester Massachusetts, United States, 01605University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 225462 | Ann Arbor Michigan, United States, 48109Trinity Health St. Joseph Mercy Ann Arbor /ID# 228206 | Ypsilanti Michigan, United States, 48197-1051Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 226680 | Saint Louis Park Minnesota, United States, 55416University of Mississippi Medical Center /ID# 228045 | Jackson Mississippi, United States, 39216-4500Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 259014 | Billings Montana, United States, 59102NHO Revive Research Institute, LLC /ID# 261113 | Lincoln Nebraska, United States, 68506MDACC Cooper /ID# 260320 | Camden New Jersey, United States, 08103-1461Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 226654 | East Brunswick New Jersey, United States, 08816Morristown Medical Center /ID# 239457 | Morristown New Jersey, United States, 07960-6136University of New Mexico /ID# 227332 | Albuquerque New Mexico, United States, 87102-4517Presbyterian Kaseman Hospital /ID# 262084 | Albuquerque New Mexico, United States, 87110Presbyterian Rust Medical Center /ID# 262068 | Rio Rancho New Mexico, United States, 87124Roswell Park Cancer Institute /ID# 239127 | Buffalo New York, United States, 14263NYU Langone Hospital - Long Island /ID# 262412 | Mineola New York, United States, 11501New York Cancer and Blood Specialists- New Hyde Park /ID# 265392 | New Hyde Park New York, United States, 11042NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 226141 | New York New York, United States, 10016-4744New York Cancer and Blood Specialists- Manhattan /ID# 265391 | New York New York, United States, 10028Icahn School of Medicine at Mount Sinai /ID# 225370 | New York New York, United States, 10029Memorial Sloan Kettering Cancer Center-Koch Center /ID# 225379 | New York New York, United States, 10065-6007New York Cancer and Blood Specialists /ID# 261114 | Port Jefferson Station New York, United States, 11776-8060New York Cancer and Blood Specialists- Eastchester, Bronx /ID# 265396 | The Bronx New York, United States, 10469Novant Health Presbyterian Medical Center /ID# 227753 | Charlotte North Carolina, United States, 28204East Carolina University - Brody School of Medicine /ID# 225992 | Greenville North Carolina, United States, 27834Novant Health Forsyth Medical Center /ID# 228339 | Winston-Salem North Carolina, United States, 27103University of Cincinnati /ID# 225374 | Cincinnati Ohio, United States, 45267OhioHealth Arthur G.H. Bing, MD Cancer Center /ID# 260790 | Columbus Ohio, United States, 43214-3908University of Oklahoma, Stephenson Cancer Center /ID# 225556 | Oklahoma City Oklahoma, United States, 73104-5418Kaiser Permanente - Northwest /ID# 225488 | Portland Oregon, United States, 97227Houston Methodist Hospital /ID# 258957 | Houston Texas, United States, 77030Millennium Research & Clinical Development /ID# 228284 | Kingwood Texas, United States, 77339-6008Joe Arrington Cancer Research /ID# 227217 | Lubbock Texas, United States, 79410Baylor Scott & White Medical Center- Temple /ID# 225935 | Temple Texas, United States, 76508-0001Intermountain Medical Center /ID# 231184 | Murray Utah, United States, 84107-5701University of Virginia Cancer Center - West Complex /ID# 225433 | Charlottesville Virginia, United States, 22903-3363Virginia Commonwealth University Medical Center Main Hospital /ID# 225796 | Richmond Virginia, United States, 23219Vista Oncology - East Olympia /ID# 229375 | Olympia Washington, United States, 98506-5028MultiCare Institute for Research & Innovation /ID# 225432 | Tacoma Washington, United States, 98405MultiCare Regional Cancer Center - Tacoma /ID# 265285 | Tacoma Washington, United States, 98405Liverpool Hospital /ID# 230072 | Liverpool New South Wales, Australia, 2170Royal Adelaide Hospital /ID# 225683 | Adelaide South Australia, Australia, 5000Monash Health - Monash Medical Centre /ID# 225680 | Clayton Victoria, Australia, 3168Austin Health /ID# 225716 | Heidelberg Victoria, Australia, 3084The Alfred Hospital /ID# 225999 | Melbourne Victoria, Australia, 3004Hollywood Private Hospital /ID# 251837 | Nedlands Western Australia, Australia, 6009Perth Blood Institute Ltd /ID# 225679 | Nedlands Western Australia, Australia, 6009Royal Perth Hospital /ID# 226583 | Perth Western Australia, Australia, 6000Universitaetsklinikum St. Poelten /ID# 234016 | Sankt Pölten Lower Austria, Austria, 3100Medizinische Universitaet Wien /ID# 252095 | Vienna State of Vienna, Austria, 1090Klinik Ottakring /ID# 243941 | Vienna State of Vienna, Austria, 1160Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228360 | Salzburg , Austria, 5020Duplicate_ZAS Middelheim /ID# 225741 | Antwerp Antwerpen, Belgium, 2020ZAS Cadix /ID# 264327 | Antwerp Antwerpen, Belgium, 2030Cliniques Universitaires UCL Saint-Luc /ID# 225737 | Woluwe-Saint-Lambert Brussels Capital, Belgium, 1200Hospital La Louviere Site Jolimont - Helora /ID# 225738 | La Louvière Hainaut, Belgium, 7100CHU de Liège /ID# 225952 | Liège Liege, Belgium, 4000Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 225742 | Yvoir Namur, Belgium, 5530UZ Gent /ID# 250031 | Ghent Oost-Vlaanderen, Belgium, 9000Vitaz /Id# 226153 | Sint-Niklaas Oost-Vlaanderen, Belgium, 9100Universitair Ziekenhuis Leuven /ID# 225951 | Leuven Vlaams-Brabant, Belgium, 3000AZ-Delta /ID# 225736 | Roeselare West-Vlaanderen, Belgium, 8800Institut Jules Bordet /ID# 225954 | Anderlecht , Belgium, 1070AZ Sint-Jan Brugge /ID# 225735 | Bruges , Belgium, 8000Hospital de Clinicas da Universidade Federal do Parana /ID# 226027 | Curitiba Paraná, Brazil, 80060-900Hospital Erasto Gaertner /ID# 262593 | Curitiba Puerto Rico, Brazil, 81520-060Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065 | Jaú São Paulo, Brazil, 17210-070Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809 | São Paulo São Paulo, Brazil, 01509-900Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 252832 | São Paulo São Paulo, Brazil, 05652-900Instituto Nacional de Cancer (INCA) /ID# 226026 | Rio de Janeiro , Brazil, 20231-050Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023 | São Paulo , Brazil, 01323-001Hospital Alemao Oswaldo Cruz /ID# 252833 | São Paulo , Brazil, 01323-020Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 262394 | São Paulo , Brazil, 01401-002Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 226048 | São Paulo , Brazil, 05403-000UMHAT Sveti Georgi /ID# 245780 | Plovdiv , Bulgaria, 4002Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616 | Sofia , Bulgaria, 1407UMHAT Sveti Ivan Rilski /ID# 244615 | Sofia , Bulgaria, 1431SHAT Hematologic Diseases /ID# 250102 | Sofia , Bulgaria, 1797Arthur J.E. Child Comprehensive Cancer Centre Pharmacy /ID# 226077 | Calgary Alberta, Canada, T2N 5G2BC Cancer - Vancouver /ID# 230573 | Vancouver British Columbia, Canada, V5Z 1L3William Osler Health System /ID# 250973 | Brampton Ontario, Canada, L6R 3J7Juravinski Cancer Centre /ID# 226084 | Hamilton Ontario, Canada, L8V 1C3Saskatoon Cancer Centre /ID# 226082 | Saskatoon Saskatchewan, Canada, S7N 4H4The Fifth Medical Center of PLA General Hospital /ID# 230941 | Beijing Beijing Municipality, China, 100071Beijing Cancer Hospital /ID# 229819 | Beijing Beijing Municipality, China, 100142Peking University Third Hospital /ID# 230975 | Beijing Beijing Municipality, China, 100191Fujian Provincial Cancer Hospital /ID# 238430 | Fuzhou Fujian, China, 350014The First Affiliated Hospital of Xiamen University /ID# 238426 | Xiamen Fujian, China, 361003Sun Yat-Sen University Cancer Center /ID# 238371 | Guangzhou Guangdong, China, 510060Guangdong Provincial People's Hospital /ID# 230945 | Guangzhou Guangdong, China, 510080Nanfang Hospital of Southern Medical University /ID# 238436 | Guangzhou Guangdong, China, 510515Fourth Hospital of Hebei Medical University /ID# 238656 | Shijiazhuang Hebei, China, 050011Harbin Medical University Cancer Hospital /Id# 241755 | Harbin Heilongjiang, China, 150081Henan Cancer Hospital /ID# 230398 | Zhengzhou Henan, China, 450008Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234152 | Wuhan Hubei, China, 430022Hubei Cancer Hospital /ID# 232256 | Wuhan Hubei, China, 430079The First Affiliated Hospital of Soochow University /ID# 232569 | Suzhou Jiangsu, China, 215006The Affiliated Hospital of Xuzhou Medical College /ID# 233174 | Xuzhou Jiangsu, China, 221006The First Affiliated Hospital of Nanchang University /ID# 230399 | Nanchang Jiangxi, China, 330006Jiangxi Provincial Cancer Hospital /ID# 233379 | Nanchang Jiangxi, China, 330029The First Hospital of Jilin University /ID# 239618 | Changchun Jilin, China, 130021The First Hospital of China Medical University /ID# 233201 | Shenyang Liaoning, China, 110001Shandong Cancer Hospital /ID# 233200 | Jinan Shandong, China, 251601Fudan University Cancer Hospital /ID# 251516 | Shanghai Shanghai Municipality, China, 200032Shanxi Provincial Cancer Hospital /ID# 250745 | Taiyuan Shanxi, China, 030013Tianjin Cancer Hospital /ID# 230974 | Tianjin Tianjin Municipality, China, 300000Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 259904 | Tianjin Tianjin Municipality, China, 300020The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230387 | Hangzhou Zhejiang, China, 310003The second affiliated hospital of Zhejiang University school of medicine /ID# 231249 | Hangzhou Zhejiang, China, 310009Zhejiang Cancer hospital /ID# 231388 | Hangzhou Zhejiang, China, 310022Clinical Hospital Dubrava /ID# 251809 | Zagreb City of Zagreb, Croatia, 10000Klinicka bolnica Merkur /ID# 252481 | Zagreb City of Zagreb, Croatia, 10000Klinicki bolnicki centar Zagreb /ID# 250709 | Zagreb City of Zagreb, Croatia, 10000Klinicki bolnicki centar Rijeka /ID# 251811 | Rijeka Primorje-Gorski Kotar County, Croatia, 51000Klinicki Bolnicki Centar (KBC) Split /ID# 250729 | Split Split-Dalmatia County, Croatia, 21000Opca bolnica Dr. Josip Bencevic /ID# 251812 | Slavonski Brod , Croatia, 35000Fakultní Nemocnice Brno - Jihlavská /ID# 225953 | Brno Brno-mesto, Czechia, 625 00Fakultní nemocnice Hradec Králové - Sokolská /ID# 225955 | Hradec Králové Hradec Kralove, Czechia, 500 05Fakultni Nemocnice Ostrava /ID# 225957 | Ostrava Ostrava-mesto, Czechia, 708 52Fakultni nemocnice Kralovske Vinohrady /ID# 225956 | Prague , Czechia, 100 34Vseobecna fakultni nemocnice v Praze /ID# 225396 | Prague , Czechia, 128 08Duplicate_Fakultni Nemocnice v Motole /ID# 225958 | Prague , Czechia, 150 00Rigshospitalet /ID# 226576 | Copenhagen Ø Capital Region, Denmark, 2100Aarhus Universitetshospital - Skejby /ID# 226594 | Aarhus Central Jutland, Denmark, 8200Roskilde Sygehus /ID# 226597 | Roskilde Region Sjælland, Denmark, 4000Odense University Hospital /ID# 226593 | Odense Region Syddanmark, Denmark, 5000Sygehus Lillebalt, Vejle /ID# 226592 | Vejle Region Syddanmark, Denmark, 7100CHU de Nice - Hôpital Archet 1 /ID# 226127 | Nice Alpes-Maritimes, France, 06200CHU Clermont-Ferrand /ID# 229283 | Clermont Auvergne-Rhône-Alpes, France, 63100Institut Paoli-Calmettes /ID# 226557 | Marseille Bouches-du-Rhone, France, 13009CHU de Rennes - PONTCHAILLOU /ID# 228207 | Rennes Brittany Region, France, 35000CHU Dijon /ID# 238345 | Dijon Cote-d Or, France, 21000CHU Limoges - Dupuytren 1 /ID# 234235 | Limoges Franche-Comte, France, 87042CHU Montpellier - Hopital Saint Eloi /ID# 228191 | Montpellier Herault, France, 34295CHU Grenoble - Hopital Michallon /ID# 226128 | La Tronche Isere, France, 38700CHRU Nancy - Hopitaux de Brabois /ID# 226102 | Vandœuvre-lès-Nancy Meurthe-et-Moselle, France, 54500CHRU Lille - Hopital Claude Huriez /ID# 226101 | Lille Nord, France, 59037Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 226560 | Créteil Paris, France, 94010CHU de Nantes, Hotel Dieu -HME /ID# 226125 | Nantes Pays de la Loire Region, France, 44000Centre Hospitalier de la Cote Basque /ID# 249143 | Bayonne Pyrenees-Atlantiques, France, 64100HCL - Hopital Lyon Sud /ID# 227086 | Pierre-Bénite Rhone, France, 69495Centre Henri Becquerel /ID# 226103 | Rouen Seine-Maritime, France, 76038CHU Amiens-Picardie Site Sud /ID# 238347 | Amiens Somme, France, 80054CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 243899 | La Roche-sur-Yon Vendee, France, 85000CHU Poitiers - La miletrie /ID# 226578 | Poitiers Vienne, France, 86000Chu Angers /Id# 245931 | Angers , France, 49933CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582 | Caen , France, 14033Hôpital Saint-Louis /ID# 226126 | Paris , France, 75010Institut Curie - site CLCC René Huguenin /ID# 253519 | Saint-Cloud , France, 92210Hopital Pitie Salpetriere /ID# 238343 | Paris Île-de-France Region, France, 75013General Hospital of Athens Laiko /ID# 225399 | Athens Attica, Greece, 11527Alexandra General Hospital /ID# 225402 | Athens Attica, Greece, 11528University General Hospital Attikon /ID# 225401 | Athens Attica, Greece, 12462General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416 | Athens , Greece, 10676University General Hospital of Ioannina /ID# 225400 | Ioannina , Greece, 45500General University Hospital of Thessaloniki AXEPA /ID# 225398 | Thessaloniki , Greece, 54636Theageneio Anticancer Hospital /ID# 225516 | Thessaloniki , Greece, 54639Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 257189 | Győr Győr-Moson-Sopron, Hungary, 9024Debreceni Egyetem-Klinikai Kozpont /ID# 226821 | Debrecen Hajdú-Bihar, Hungary, 4032Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245938 | Kaposvár Somogy County, Hungary, 7400Tolna Varmegyei Balassa Janos Korhaz /ID# 250063 | Szekszárd Tolna County, Hungary, 7100Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 226846 | Szombathely Vas County, Hungary, 9700Semmelweis Egyetem /ID# 227239 | Budapest , Hungary, 1085Orszagos Onkologiai Intezet /ID# 227294 | Budapest , Hungary, 1122Szegedi Tudományegyetem /ID# 226838 | Szeged , Hungary, 6720Meir Medical Center /ID# 225612 | Kfar Saba Central District, Israel, 4428164Assuta Tel Aviv Medical Center /ID# 226066 | Tel Aviv Central District, Israel, 6971028Rambam Health Care Campus /ID# 225981 | Haifa H_efa, Israel, 3109601Shaare Zedek Medical Center /ID# 259796 | Jerusalem Jerusalem, Israel, 91031Hadassah /ID# 225614 | Jerusalem Jerusalem, Israel, 91120The Chaim Sheba Medical Center /ID# 225600 | Ramat Gan Tel Aviv, Israel, 5265601Tel Aviv Sourasky Medical Center /ID# 225891 | Tel Aviv Tel Aviv, Israel, 6423906Rabin Medical Center /ID# 225862 | Petah Tikva , Israel, 4941492IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 225551 | Bologna Emilia-Romagna, Italy, 40138Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 225554 | San Giovanni Rotondo Foggia, Italy, 71013IRCCS Ospedale San Raffaele /ID# 225555 | Milan Milano, Italy, 20132Istituto Europeo Di Oncologia /ID# 225545 | Milan Milano, Italy, 20141Azienda Ospedaliera Universitaria Federico II /ID# 225543 | Naples Napoli, Italy, 80131A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 225775 | Turin Piedmont, Italy, 10126Duplicate_Centro di Riferimento Oncologico /ID# 225553 | Aviano Pordenone, Italy, 33081Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 252192 | Meldola Reggio Emilia, Italy, 47014Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 225751 | Candiolo Torino, Italy, 10060Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Aless /ID# 225542 | Alessandria , Italy, 15100I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 225548 | Bari , Italy, 70124Duplicate_ASST Spedali civili di Brescia /ID# 225549 | Brescia , Italy, 25123Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773 | Novara , Italy, 28100Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 225541 | Palermo , Italy, 90146Azienda Ospedaliero Universitaria Pisana /ID# 225575 | Pisa , Italy, 56126Ospedale Santa Maria Delle Croci /ID# 225571 | Ravenna , Italy, 48121NHO Nagoya Medical Center /ID# 230677 | Nagoya Aichi-ken, Japan, 460-0001Aichi Cancer Center Hospital /ID# 226090 | Nagoya Aichi-ken, Japan, 464-8681National Cancer Center Hospital East /ID# 250151 | Kashiwa-shi Chiba, Japan, 277-8577Matsuyama Red Cross Hospital /ID# 251068 | Matsuyama Ehime, Japan, 790-8524National Hospital Organization Kyushu Cancer Center /ID# 251622 | Fukuoka Fukuoka, Japan, 811-1395Kyushu University Hospital /ID# 226091 | Fukuoka Fukuoka, Japan, 812-8582Fukushima Medical University Hospital /ID# 250869 | Fukushima Fukushima, Japan, 960-1295Duplicate_Hokkaido University Hospital /ID# 250149 | Sapporo Hokkaido, Japan, 060-8648Kobe City Medical Center General Hospital /ID# 250597 | Kobe Hyōgo, Japan, 650-0047University of Tsukuba Hospital /ID# 251282 | Tsukuba Ibaraki, Japan, 305-8576Kanazawa University Hospital /ID# 251770 | Kanazawa Ishikawa-ken, Japan, 920-8641Kagoshima University Hospital /ID# 250163 | Kagoshima Kagoshima-ken, Japan, 890-8520Tokai University Hospital /ID# 251281 | Isehara Kanagawa, Japan, 259-1193Tohoku University Hospital /ID# 250150 | Sendai Miyagi, Japan, 9808574Okayama University Hospital /ID# 250161 | Okayama Okayama-ken, Japan, 700-8558Kindai University Hospital /ID# 250160 | Osakasayama-shi Osaka, Japan, 589-8511Osaka University Hospital /ID# 251283 | Suita-shi Osaka, Japan, 565-0871National Cancer Center Hospital /ID# 226089 | Chuo-ku Tokyo, Japan, 104-0045The Cancer Institute Hospital Of JFCR /ID# 230269 | Koto-ku Tokyo, Japan, 135-8550Yamagata University Hospital /ID# 230003 | Yamagata Yamagata, Japan, 990-9585Flevo Ziekenhuis /ID# 229606 | Almere Stad Flevoland, Netherlands, 1315 RAGelre Ziekenhuizen /ID# 229762 | Apeldoorn Gelderland, Netherlands, 7334 DZCanisius-Wilhelmina Ziekenhuis /ID# 231291 | Nijmegen Gelderland, Netherlands, 6532 SZMaastricht Universitair Medisch Centrum /ID# 225607 | Maastricht Limburg, Netherlands, 6229 HXAmphia Ziekenhuis /ID# 229550 | Breda North Brabant, Netherlands, 4818 CKCatharina Ziekenhuis /ID# 230465 | Eindhoven North Brabant, Netherlands, 5623 EJMaxima Medisch Centrum /ID# 225603 | Eindhoven North Brabant, Netherlands, 5631 BMElisabeth Tweesteden Ziekenhuis /ID# 229773 | Tilburg North Brabant, Netherlands, 5022 GCNoordwest Ziekenhuisgroep /ID# 230613 | Alkmaar North Holland, Netherlands, 1815 JDVrije Universiteit Medisch Centrum /ID# 225608 | Amsterdam North Holland, Netherlands, 1081 HVOlvg /Id# 229761 | Amsterdam North Holland, Netherlands, 1091 ACSpaarne Gasthuis, Haarlem Zuid /ID# 229621 | Haarlem North Holland, Netherlands, 2035 RCTergooi /ID# 229772 | Hilversum North Holland, Netherlands, 1213 XZDijklander Ziekenhuis /ID# 229900 | Hoorn North Holland, Netherlands, 1624 NPZaans Medisch Centrum /ID# 230614 | Zaandam North Holland, Netherlands, 1502 DVMedisch Spectrum Twente /ID# 225610 | Enschede Overijssel, Netherlands, 7512 KZMedisch Centrum Leeuwarden /ID# 225605 | Leeuwarden Provincie Friesland, Netherlands, 8934 ADAlbert Schweitzer Ziekenhuis /ID# 229560 | Dordrecht South Holland, Netherlands, 3318 ATLeids Universitair Medisch Centrum /ID# 225606 | Leiden South Holland, Netherlands, 2333 ZAMeander Medisch Centrum /ID# 229608 | Amersfoort Utrecht, Netherlands, 3813 TZSt. Antonius Ziekenhuis /ID# 229901 | Nieuwegein Utrecht, Netherlands, 3435 CMJeroen Bosch Ziekenhuis /ID# 229765 | 's-Hertogenbosch , Netherlands, 5223 GZDeventer Ziekenhuis /ID# 229937 | Deventer , Netherlands, 7416 SEUniversitair Medisch Centrum Groningen /ID# 225602 | Groningen , Netherlands, 9713 GZHaaglanden Medisch Centrum /ID# 229686 | The Hague , Netherlands, 2512 VADiakonessenhuis /ID# 251793 | Utrecht , Netherlands, 3582 KENorth Shore Hospital /ID# 250992 | Takapuna Auckland, New Zealand, 0622Christchurch Hospital /ID# 250993 | Christchurch Canterbury, New Zealand, 8011ARS-MEDICAL Sp. z o.o. /ID# 225848 | Piła Greater Poland Voivodeship, Poland, 64-920Centrum Medyczne Pratia Poznan /ID# 227236 | Skórzewo Greater Poland Voivodeship, Poland, 60-185Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723 | Słupsk Pomeranian Voivodeship, Poland, 76-200Szpital Kliniczny MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985 | Olsztyn Warmian-Masurian Voivodeship, Poland, 10-228Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 225986 | Kielce Świętokrzyskie Voivodeship, Poland, 25-7342CA-Braga, Hospital de Braga /ID# 249112 | Braga , Portugal, 4710-243IPO Lisboa FG, EPE /ID# 249109 | Lisbon , Portugal, 1099-023Unidade Local de Saude de Santa Maria, EPE /ID# 249111 | Lisbon , Portugal, 1649-035IPO Porto FG, EPE /ID# 249110 | Porto , Portugal, 4200-072Hematology and Oncology Institute /ID# 230054 | Manati , Puerto Rico, 00674Pan American Center for Oncology Trials, LLC /ID# 230052 | Rio Piedras , Puerto Rico, 00935Narodny onkologicky ustav /ID# 238847 | Bratislava Bratislava Region, Slovakia, 833 10Univerzitna nemocnica Martin /ID# 240828 | Martin Žilina Region, Slovakia, 036 01Wits Clinical Research /ID# 227799 | Johannesburg Gauteng, South Africa, 1864Wits Clinical Research /ID# 227803 | Johannesburg Gauteng, South Africa, 1864Alberts Cellular Therapy /ID# 227798 | Pretoria Gauteng, South Africa, 0044University of Cape Town /ID# 227802 | Cape Town Western Cape, South Africa, 7925Haemalife Inc. /ID# 243391 | Kuils River Western Cape, South Africa, 7580Inje University - Busan Paik Hospital /ID# 232262 | Busan Busan Gwang Yeogsi, South Korea, 47392Seoul National University Bundang Hospital /ID# 225763 | Seongnam-si Gyeonggido, South Korea, 13620Keimyung University Dongsan Hospital /ID# 232264 | Daegu Gyeongsangbuk-do, South Korea, 42601Dong-A University Medical Center /ID# 228451 | Pusan Gyeongsangnam-do, South Korea, 49201Jeonbuk National University Hospital /ID# 232263 | Jeonju Jeonrabugdo, South Korea, 54907Seoul National University Hospital /ID# 225760 | Seoul Seoul Teugbyeolsi, South Korea, 03080Asan Medical Center /ID# 225758 | Seoul Seoul Teugbyeolsi, South Korea, 05505Samsung Medical Center /ID# 225759 | Seoul Seoul Teugbyeolsi, South Korea, 06351The Catholic University of Korea, Seoul St. Marys Hospital /ID# 225761 | Seoul Seoul Teugbyeolsi, South Korea, 06591Ulsan University Hospital /ID# 226971 | Ulsan Ulsan Gwang Yeogsi, South Korea, 44033Instituto Catalan de Oncologia (ICO) Badalona /ID# 228063 | Badalona Barcelona, Spain, 08916Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 227393 | L'Hospitalet de Llobregat Barcelona, Spain, 08907Hospital Universitario Reina Sofia /ID# 225806 | Córdoba Cordoba, Spain, 14004Hospital Clinico Universitario Virgen de la Arrixaca /ID# 255381 | El Palmar Murcia, Spain, 30120Clinica Universidad de Navarra - Pamplona /ID# 225809 | Pamplona Navarre, Spain, 31008Hospital Parc de Salut del Mar /ID# 225810 | Barcelona , Spain, 08003Hospital Universitario Vall d'Hebron /ID# 225811 | Barcelona , Spain, 08035Hospital Clinic de Barcelona /ID# 226651 | Barcelona , Spain, 08036Hospital Santa Creu i Sant Pau /ID# 225813 | Barcelona , Spain, 08041CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228 | Madrid , Spain, 28027Hospital Universitario Infanta Leonor /ID# 225816 | Madrid , Spain, 28031MD Anderson Madrid /ID# 225817 | Madrid , Spain, 28033Hospital Universitario Ramon y Cajal /ID# 241750 | Madrid , Spain, 28034Hospital Universitario Fundacion Jimenez Diaz /ID# 225804 | Madrid , Spain, 28040Hospital Universitario 12 de Octubre /ID# 225815 | Madrid , Spain, 28041Hospital Clinico Universitario de Valencia /ID# 225818 | Valencia , Spain, 46010Skane University Hospital Lund /ID# 227285 | Lund Skåne County, Sweden, 224 84Karolinska University Hospital Solna /ID# 229284 | Solna Stockholm County, Sweden, 171 64Sodra Alvsborgs sjukhus /ID# 228885 | Borås Västra Götaland County, Sweden, 501 82Sahlgrenska Universitetssjukhuset /ID# 250089 | Gothenburg Västra Götaland County, Sweden, 413 46Linkoping University Hospital /ID# 233521 | Linköping Östergötland County, Sweden, 581 85Kantonsspital Aarau AG /ID# 229112 | Aarau Canton of Aargau, Switzerland, 5001Spital Thun /ID# 229499 | Thun Canton of Bern, Switzerland, 3600KSW Kantonsspital Winterthur /ID# 241631 | Winterthur Canton of Zurich, Switzerland, 8400Kaohsiung Chang Gung Memorial Hospital /ID# 226670 | Kaohsiung City Kaohsiung, Taiwan, 833China Medical University Hospital /ID# 226188 | Taichung , Taiwan, 40447Taichung Veterans General Hospital /ID# 226674 | Taichung , Taiwan, 40705National Cheng Kung University Hospital /ID# 226671 | Tainan , Taiwan, 704Anadolu Saglik Merkezi /ID# 225777 | Dilovası Kocaeli, Turkey (Türkiye), 41455Ankara Universitesi Fakultesi /ID# 227331 | Ankara , Turkey (Türkiye), 06620Inonu University Medical Faculty /ID# 226572 | Malatya , Turkey (Türkiye), 44280Ondokuz Mayis Universitesi /ID# 251247 | Samsun , Turkey (Türkiye), 55139Karadeniz University /ID# 226573 | Trabzon , Turkey (Türkiye), 61000Baskent Universitesi Adana Uyg. ve Arast. Merkezi Yuregir Baskent Hastanesi /ID# 225921 | Yüreğir , Turkey (Türkiye), 01240Hammersmith Hospital /ID# 242215 | London England, United Kingdom, W12 0HSNorfolk and Norwich University Hospitals NHS Foundation Trust /ID# 226692 | Norwich Norfolk, United Kingdom, NR4 7UYUniversity Hospitals Birmingham NHS Foundation Trust /ID# 229197 | Birmingham , United Kingdom, B15 2THNHS Lothian /ID# 229055 | Edinburgh , United Kingdom, EH3 9HE
Investigators
Study Director: ABBVIE INC., AbbVie