Clinical trial NCT05409066: Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
Official title: A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Follicular Lymphoma (FL)
Keywords: Follicular Lymphoma (FL)
Non-Hodgkin's lymphoma (NHL)
Lymphoma
Cancer
Epcoritamab
Rituximab
Lenalidomide
EPCORE FL-1
EPCORE
Lead sponsor: Genmab
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2022-06-08
Enrollment: 549
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.

Participants will receive R2 (375 mg/m\^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).

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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
* Participant has:

  * Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
  * \>= 1 measurable nodal lesion (long axis \> 1.5 cm) or \>= 1 measurable extra-nodal lesion (long axis \> 1.0 cm) on CT scan or MRI.
* Histologically confirmed classic follicular lymphoma (FL) \[previously Grade 1 to 3a FL\] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.
* Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)
* Eligible to receive R2 per investigator determination.
* Estimated Creatinine Clearance (CrCl) \>= 50 mL/min.

Exclusion Criteria:

* Documented refractoriness to lenalidomide.
* Have lenalidomide exposure within 12 months prior to randomization.

Primary outcomes:
measure: Percentage of Participants Achieving Best Overall Response (BOR)
timeFrame: Up to approximately 5 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Percentage of Participants Achieving CR
timeFrame: Up to approximately 5 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 8 years from randomization
measure: Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity
timeFrame: Up to approximately 5 years
measure: Change in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
timeFrame: Up to approximately 8 years
measure: PFS as Assessed by Investigator
timeFrame: Up to approximately 5 years
measure: Percentage of Participants Achieving BOR as Assessed by Investigator
timeFrame: Up to approximately 5 years
measure: Percentage of Participants Achieving CR as Assessed by Investigator
timeFrame: Up to approximately 5 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 8 years
measure: Duration of Complete Response (DOCR)
timeFrame: Up to approximately 8 years
measure: Time to Progression (TTP)
timeFrame: Up to approximately 8 years
measure: Time to Next Anti-Lymphoma Treatment (TTNLT)
timeFrame: Up to approximately 8 years
measure: Percentage of Participants Achieving CR at the End of Treatment
timeFrame: Up to approximately 5 years
measure: Time to Response (TTR)
timeFrame: Up to approximately 8 years
measure: Time to Complete Response (TTCR)
timeFrame: Up to approximately 8 years
measure: Event-Free Survival (EFS)
timeFrame: Up to approximately 8 years
measure: Time to next anti-lymphoma treatment (TTNLT)
timeFrame: Up to approximately 8 years
measure: Change in Patient's Global Impression of Severity (PGIS)
timeFrame: Up to approximately 8 years
measure: Change in Patient's Global Impression of Change (PGIC)
timeFrame: Up to approximately 8 years
measure: Change in EuroQol 5-Dimension Questionnaire, 5-level (EQ-5D-5L)
timeFrame: Up to approximately 8 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center - North Campus /ID# 228862
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences /ID# 227198
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center for Research /ID# 229428
state: California
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center /ID# 231535
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Ct /ID# 228997
state: California
city: Los Angeles
country: United States
facility: University of Southern California /ID# 227195
state: California
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials /ID# 268502
state: California
city: Atlanta
country: United States
facility: Emory University /ID# 227299
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Cancer Care - Waterfront Plaza /ID# 262448
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 227248
state: Illinois
city: Goshen
country: United States
facility: Goshen Center for Cancer Care /ID# 227189
state: Indiana
city: Indianapolis
country: United States
facility: Community Health Network, Inc. /ID# 259756
state: Indiana
city: Baton Rouge
country: United States
facility: Our Lady Of The Lake Regional Medical Center /ID# 251393
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Baltimore /ID# 227191
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 245233
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center /ID# 227323
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital /ID# 227250
state: Michigan
city: Chesterfield
country: United States
facility: St. Luke's Hospital - Chesterfield /ID# 247817
state: Missouri
city: Billings
country: United States
facility: Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220
state: Montana
city: Morristown
country: United States
facility: Morristown Medical Center /ID# 231427
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute /ID# 239128
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island /ID# 253343
state: New York
city: New York
country: United States
facility: NYU Laura and Isaac Perlmutter Cancer Center /ID# 227322
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai /ID# 227181
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193
state: New York
city: Greenville
country: United States
facility: East Carolina University - Brody School of Medicine /ID# 227192
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma, Stephenson Cancer Center /ID# 227325
state: Oklahoma
city: Dallas
country: United States
facility: Baylor Sammons Cancer Center /ID# 261584
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas /ID# 265890
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Healthcare LDS Hospital /ID# 259948
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 227211
state: Virginia
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Fundaleu /Id# 229700
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Cemic /Id# 229697
state: Ciudad Autonoma De Buenos Aires
city: Cordoba
country: Argentina
facility: Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 229701
city: Santa Fe
country: Argentina
facility: Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital /ID# 239272
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital /ID# 239093
state: New South Wales
city: Douglas
country: Australia
facility: Townsville University Hospital /ID# 231124
state: Queensland
city: Frankston
country: Australia
facility: Peninsula Private Hospital /ID# 238796
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital /ID# 231122
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital /ID# 230456
state: Western Australia
city: Perth
country: Australia
facility: Hollywood Private Hospital /ID# 251789
state: Western Australia
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum St. Poelten /ID# 234015
state: Niederoesterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 247510
state: Oberoesterreich
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228366
city: Edegem
country: Belgium
facility: Uza /Id# 228521
state: Antwerpen
city: La Louvière
country: Belgium
facility: Hospital La Louviere Site Jolimont - Helora /ID# 228520
state: Hainaut
city: Sint-Niklaas
country: Belgium
facility: Vitaz /Id# 228525
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 247780
state: Vlaams-Brabant
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet /ID# 254676
city: Liege
country: Belgium
facility: Groupe Sante CHC - Clinique du MontLegia /ID# 230415
city: Turnhout
country: Belgium
facility: AZ Turnhout - Campus Sint-Elisabeth /ID# 231628
city: Curitiba
country: Brazil
facility: Hospital de Clinicas da Universidade Federal do Parana /ID# 228123
state: Parana
city: Botucatu
country: Brazil
facility: Upeclin Fmb - Unesp /Id# 252912
state: Sao Paulo
city: Jaú
country: Brazil
facility: Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 228129
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer (INCA) /ID# 228706
city: Sao Paulo
country: Brazil
facility: Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121
city: Sao Paulo
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 252918
city: Sao Paulo
country: Brazil
facility: Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 228127
city: Edmonton
country: Canada
facility: Cross Cancer Institute /ID# 249080
state: Alberta
city: Victoria
country: Canada
facility: BC Cancer - Victoria /ID# 228850
state: British Columbia
city: Levis
country: Canada
facility: CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896
state: Quebec
city: Quebec City
country: Canada
facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 231537
state: Quebec
city: Rimouski
country: Canada
facility: CISSSBSL -Hopital regional de Rimouski /ID# 229894
state: Quebec
city: Beijing
country: China
facility: Peking University First Hospital /ID# 250517
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 230885
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital /ID# 233919
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University /ID# 238427
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center /ID# 231463
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Peoples Hospital（Huifu Campus） /ID# 232512
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 230383
state: Guangdong
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University /ID# 238657
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital /ID# 230459
state: Henan
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234153
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital /ID# 232255
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital /ID# 232153
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University /ID# 232511
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College /ID# 232513
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University /ID# 231047
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital /ID# 232507
state: Jiangxi
city: Shenyang
country: China
facility: The First Hospital of China Medical University /ID# 232509
state: Liaoning
city: Xi'an
country: China
facility: Xijing Hospital /ID# 238650
state: Shaanxi
city: Shanghai
country: China
facility: Fudan University Cancer Hospital /ID# 250475
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Cancer Hospital /ID# 230876
state: Tianjin
city: Kunming
country: China
facility: Yunnan Cancer Hospital /ID# 232062
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230390
state: Zhejiang
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University school of medicine /ID# 231250
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer hospital /ID# 231389
state: Zhejiang
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové - Sokolská /ID# 228269
state: Hradec Kralove
city: Prague
country: Czechia
facility: Duplicate_Fakultni Nemocnice v Motole /ID# 228272
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady /ID# 228564
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze /ID# 228565
city: Herning
country: Denmark
facility: Regionshospitalet Godstrup /ID# 227466
state: Midtjylland
city: Vejle
country: Denmark
facility: Sygehus Lillebalt, Vejle /ID# 227404
state: Syddanmark
city: Clermont
country: France
facility: CHU Clermont-Ferrand /ID# 238676
state: Auvergne-Rhone-Alpes
city: Rennes
country: France
facility: CHU de Rennes - PONTCHAILLOU /ID# 230356
state: Bretagne
city: Dijon
country: France
facility: CHU Dijon /ID# 230354
state: Cote-d Or
city: Limoges CEDEX 1
country: France
facility: CHU Limoges - Dupuytren 1 /ID# 231450
state: Franche-Comte
city: Nimes CEDEX 9
country: France
facility: CHU NIMES - Hopital Caremeau /ID# 230351
state: Gard
city: Pessac CEDEX
country: France
facility: Centre Hospitalier Universitaire de Bordeaux /ID# 230347
state: Gironde
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 230360
state: Ile-de-France
city: Reims CEDEX
country: France
facility: CHU Reims - Hôpital Robert Debre /ID# 248710
state: Marne
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU Nancy - Hopitaux de Brabois /ID# 241595
state: Meurthe-et-Moselle
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 230353
state: Nord
city: Toulouse Cedex 9
country: France
facility: IUCT Oncopole /ID# 233486
state: Occitanie
city: Creteil
country: France
facility: Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 230358
state: Paris
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 245928
state: Pays-de-la-Loire
city: Lyon CEDEX 08
country: France
facility: Centre Leon Berard /ID# 230348
state: Rhone
city: Pierre Benite CEDEX
country: France
facility: HCL - Hopital Lyon Sud /ID# 231449
state: Rhone
city: La Roche Sur Yon
country: France
facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 234095
state: Vendee
city: Poitiers
country: France
facility: CHU Poitiers - La miletrie /ID# 230357
state: Vienne
city: Caen
country: France
facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929
city: Paris
country: France
facility: Hôpital Saint-Louis /ID# 232067
city: Tubingen
country: Germany
facility: Universitaetsklinikum Tuebingen /ID# 229663
state: Baden-Wuerttemberg
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg /ID# 229278
state: Bayern
city: Gießen
country: Germany
facility: Universitaetsklinikum Giessen /ID# 234245
state: Hessen
city: Kassel
country: Germany
facility: Klinikum Kassel /ID# 229185
state: Hessen
city: Goettingen
country: Germany
facility: Universitaetsmedizin Goettingen /ID# 230411
state: Niedersachsen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn /ID# 249401
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden /ID# 229754
state: Sachsen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig /ID# 242907
state: Sachsen
city: Jena
country: Germany
facility: Universitaetsklinikum Jena /ID# 232064
state: Thueringen
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg /ID# 229184
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch /ID# 229178
city: Essen
country: Germany
facility: Universitaetsklinikum Essen /ID# 229180
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universitaet /ID# 230144
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromäerinnen /ID# 232354
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 226626
state: Attiki
city: Athens
country: Greece
facility: Alexandra General Hospital /ID# 226632
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 226629
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina /ID# 226628
city: Thessaloniki
country: Greece
facility: General University Hospital of Thessaloniki AXEPA /ID# 226630
city: Thessaloniki
country: Greece
facility: Theageneio Anticancer Hospital /ID# 226627
city: Debrecen
country: Hungary
facility: Debreceni Egyetem-Klinikai Kozpont /ID# 229287
state: Hajdu-Bihar
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246475
state: Somogy
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 232203
state: Szabolcs-Szatmar-Bereg
city: Szombathely
country: Hungary
facility: Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 229290
state: Vas
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 229291
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet /ID# 229292
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem /ID# 229289
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 227849
state: H_efa
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center /ID# 228037
state: HaMerkaz
city: Safed
country: Israel
facility: ZIV Medical Center /ID# 232257
state: HaTsafon
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 228322
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 228529
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah /ID# 227846
state: Yerushalayim
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 228043
city: San Giovanni Rotondo
country: Italy
facility: Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 228458
state: Foggia
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele /ID# 228669
state: Milano
city: Milan
country: Italy
facility: Istituto Europeo Di Oncologia /ID# 227396
state: Milano
city: Torino
country: Italy
facility: A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229820
state: Piemonte
city: Aviano
country: Italy
facility: Duplicate_Centro di Riferimento Oncologico /ID# 227395
state: Pordenone
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 230402
state: Roma
city: Candiolo
country: Italy
facility: Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602
state: Torino
city: Alessandria
country: Italy
facility: Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Aless /ID# 227401
city: Bari
country: Italy
facility: Duplicate_I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 227400
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia /ID# 227397
city: Napoli
country: Italy
facility: Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 230403
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 227399
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 227402
city: Ravenna
country: Italy
facility: Ospedale Santa Maria Delle Croci /ID# 227394
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 230678
state: Aichi
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital /ID# 230134
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital /ID# 264541
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 232423
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital /ID# 251866
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center /ID# 252245
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 230136
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 251839
state: Fukushima
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 231443
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital /ID# 251945
state: Hyogo
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Hospital /ID# 232251
state: Kagoshima
city: Isehara
country: Japan
facility: Tokai University Hospital /ID# 252135
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital /ID# 264668
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 231156
state: Kyoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 251944
state: Mie
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 232303
state: Miyagi
city: Matsumoto-shi
country: Japan
facility: Shinshu University Hospital /ID# 252246
state: Nagano
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 232009
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital /ID# 264670
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 232152
state: Osaka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 230004
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR /ID# 230271
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 230005
state: Yamagata
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital /ID# 263715
state: Yamanashi
city: Busan
country: Korea, Republic of
facility: Inje University - Busan Paik Hospital /ID# 230293
state: Busan Gwang Yeogsi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital /ID# 229798
state: Busan Gwang Yeogsi
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 228448
state: Gyeonggido
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital /ID# 229800
state: Gyeongsangbugdo
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center /ID# 228638
state: Gyeongsangnamdo
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital /ID# 228908
state: Jeonrabugdo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 228446
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 228444
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 228445
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 228447
state: Seoul Teugbyeolsi
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis /ID# 248138
state: Gelderland
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis /ID# 247739
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Olvg /Id# 247899
state: Noord-Holland
city: Hoorn Nh
country: Netherlands
facility: Dijklander Ziekenhuis /ID# 248993
state: Noord-Holland
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente /ID# 247854
state: Overijssel
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis /ID# 248644
state: Utrecht
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Ziekenhuis /ID# 247692
state: Zeeland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis /ID# 247740
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum /ID# 247742
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 248139
state: Zuid-Holland
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis /ID# 247853
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 247741
city: Papatoetoe
country: New Zealand
facility: Aotearoa Clinical Trials /ID# 228509
state: Auckland
city: Takapuna
country: New Zealand
facility: North Shore Hospital /ID# 228508
state: Auckland
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital /ID# 232352
state: Manawatu-Wanganui
city: Krakow
country: Poland
facility: Pratia MCM Krakow /ID# 229121
state: Malopolskie
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o /ID# 229122
state: Pomorskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 229362
state: Swietokrzyskie
city: Pila
country: Poland
facility: ARS-MEDICAL Sp. z o.o. /ID# 229601
state: Wielkopolskie
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan /ID# 229299
state: Wielkopolskie
city: Manati
country: Puerto Rico
facility: Hematology and Oncology Institute /ID# 230056
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials, LLC /ID# 230055
city: San Juan
country: Puerto Rico
facility: Auxilio Mutuo Cancer Center /ID# 248721
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav /ID# 239510
state: Bratislavsky Kraj
city: Johannesburg
country: South Africa
facility: Wits Clinical Research /ID# 228895
state: Gauteng
city: Pretoria
country: South Africa
facility: Alberts Cellular Therapy /ID# 228896
state: Gauteng
city: Cape Town
country: South Africa
facility: University of Cape Town /ID# 228900
state: Western Cape
city: Kuilsrivier
country: South Africa
facility: Haemalife Inc. /ID# 243392
state: Western Cape
city: Badalona
country: Spain
facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 228108
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 228107
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla /ID# 228984
state: Cantabria
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia /ID# 228122
state: Cordoba
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona /ID# 228116
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Parc de Salut del Mar /ID# 228106
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 229859
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara /ID# 248845
city: Madrid
country: Spain
facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 229157
city: Madrid
country: Spain
facility: MD Anderson Madrid /ID# 229860
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 228113
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 228110
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 228109
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca /ID# 228117
city: Sevilla
country: Spain
facility: Duplicate_Hospital Universitario Virgen del Rocio /ID# 228118
city: Lulea
country: Sweden
facility: Sunderby sjukhus /ID# 228165
state: Norrbottens Lan
city: Linkoping
country: Sweden
facility: Linkoping University Hospital /ID# 233520
state: Ostergotlands Lan
city: Boras
country: Sweden
facility: Sodra Alvsborgs sjukhus /ID# 228886
state: Vastra Gotalands Lan
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau AG /ID# 229113
state: Aargau
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden /ID# 253862
state: Graubuenden
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen /ID# 229117
state: Sankt Gallen
city: Bellinzona
country: Switzerland
facility: EOC Ospedale Regionale di Bellinzona e Valli /ID# 228922
state: Ticino
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 227384
state: Kaohsiung
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 227379
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital /ID# 227383
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 227381
city: Ankara
country: Turkey
facility: Ankara Universitesi Fakultesi /ID# 227790
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Tip Fakul /ID# 227791
city: Diyarbakir
country: Turkey
facility: Dicle Universitesi Tip /ID# 230087
city: Istanbul
country: Turkey
facility: Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 248202
city: Istanbul
country: Turkey
facility: Istanbul Florence Nightingale Hastanesi /ID# 229546
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 227855
city: Izmir
country: Turkey
facility: Ege University Medical Faculty /ID# 227792
city: Kocaeli
country: Turkey
facility: Kocaeli University Med Faculty /ID# 227854
city: Samsun
country: Turkey
facility: Ondokuz mayis University Facul /ID# 227794
city: Plymouth
country: United Kingdom
facility: Derriford Hospital and the Royal Eye Infirmary /ID# 230038
state: Devon
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 230028
state: Greater London
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust /ID# 230035
state: Oxfordshire
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde /ID# 230027
state: Scotland
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust /ID# 230471
state: West Yorkshire
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 230043
city: Colchester
country: United Kingdom
facility: East Suffolk and North Essex NHS Foundation Trust /ID# 230040
city: Liverpool
country: United Kingdom
facility: Clatterbridge Cancer Centre - Liverpool /ID# 230036
city: Manchester
country: United Kingdom
facility: The Christie Hospital /ID# 230124
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 230123
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust /ID# 230044
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: