Clinical trial NCT06191744: 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 Previously Untreated Follicular Lymphoma
Official title: A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Follicular Lymphoma (FL)
Keywords: Follicular Lymphoma (FL)
Non-Hodgkin's lymphoma (NHL)
Lymphoma
Cancer
Epcoritamab
Rituximab
Lenalidomide
Chemoimmunotherapy (CIT)
Obinutuzumab
Cyclophosphamide
Doxorubicin Hydrochloride
Vincristine Sulfate
Prednisone
Bendamustine (Benda)
R-CHOP
G-CHOP
R-Benda
G-Benda
EPCORE™FL-2
Lead sponsor: Genmab
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2024-01-05
Enrollment: 1095
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 previously untreated 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 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world.

Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \[G-CHOP\]/ R-CHOP or G and IV infusion of bendamustine (Benda) \[G-Benda\]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment.

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:

* Diagnosis of follicular lymphoma (FL).
* Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
* Are willing and able to comply with procedures required in the protocol.
* Must have stage, III, IV or II with bulky disease \>= 7cm).
* Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
* Has one or more target lesions:

  * A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
  * \>=1 measurable nodal lesion (long axis \>1.5cm) or \>=1 measurable extra-nodal lesion (long axis \>1.0 cm) on CT scan or MRI
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: \[Arm B\] at the discretion of the Investigator, and rituximab and lenalidomide (R2) \[Arm C\].
* Have laboratory values meeting the criteria in the protocol.

Exclusion Criteria:

* Had major surgery within 4 weeks prior to randomization.
* Have active cytomegalovirus (CMV) disease.

Primary outcomes:
measure: Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)
timeFrame: Up to 30 Months
measure: Arm A1 vs Arm B: Number of Participants with Progression-free survival (PFS)
timeFrame: Up to 10 Years
Secondary outcomes:
measure: Arm A1 vs Arm B: Overall Survival (OS)
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Change from Baseline in Physical Functioning (PF) According to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30)
timeFrame: 21 Weeks
measure: Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30
timeFrame: Up to 30 Months
measure: Arm A1 vs Arm C: Percentage of Participants who Achieve CR30
timeFrame: Up to 30 Months
measure: Arm A1 vs Arm A2: Number of Participants with PFS
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Number of Participants with PFS
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Rate of MRD Negativity
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Rate of MRD Negativity
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Change from Baseline in PF According to EORTC QLQ-C30
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Change from Baseline in PF According to EORTC QLQ-C30
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: OS
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: OS
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30
timeFrame: Up to 30 Months
measure: Arm A1 vs Arm B: Percentage of Participants who Achieve CR30
timeFrame: Up to 30 Months
measure: Arm A1 vs Arm C: Percentage of Participants who Achieve CR30
timeFrame: Up to 30 Months
measure: Arm A1 vs Arm A2: Number of Participants with PFS
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Number of Participants with PFS
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Number of Participants with PFS
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Number of Participants with Best Overall Response (BOR) per per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Number of Participants with BOR per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Number of Participants with BOR per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Number of Participants with BOR per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Number of Participants with BOR per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Number of Participants with BOR per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Number of Participants with Event-free Survival (EFS) per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Number of Participants with EFS per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Number of Participants with EFS per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Number of Participants with EFS per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Number of Participants with EFS per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Number of Participants with EFS per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Duration of Response (DOR) per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: DOR per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: DOR per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: DOR per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: DOR per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: DOR per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Duration of Complete Response (DOCR) per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: DOCR per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: DOCR per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: DOCR per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: DOCR per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: DOCR per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Time to Next Anti-lymphoma Therapy (TTNT) per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: TTNT per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: TTNT per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: TTNT per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: TTNT per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: TTNT per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: TTNT per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Time to Progression per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Time to Progression per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Time to Progression per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Time to Progression per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Time to Progression per IRC
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Time to Progression per Investigator
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Number of Participants with Progression-free Survival After Subsequent Anti-Lymphoma Therapy (PFS2)
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Number of Participants with PFS2
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Number of Participants with PFS2
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Change in Tolerability as Measured by Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Change in Tolerability as Measured by PRO-CTCAE
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Change in Tolerability as Measured by PRO-CTCAE
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Change in Tolerability as Measured by The Functional Assessment of Cancer Therapy - General (FACT-G) Item GP5
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Change in Tolerability as Measured by FACT-G Item GP5
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Change in Tolerability as Measured by FACT-GG Item GP5
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Change in Symptoms as Measured by The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Change in Symptoms as Measured by FACT-Lym
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Change in Symptoms as Measured by FACT-Lym
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Change in Quality of Life (QoL) as Measured by FACT-Lym
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Change in QoL as Measured by FACT-Lym
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Change in QoL as Measured by FACT-Lym
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Time-to-first PRO deterioration (TTD) in well-being using the lymphoma subscale (LymS) of FACT-Lym
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: TTD in well-being using LymS of FACT-Lym
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: TTD in well-being using LymS of FACT-Lym
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Change in QoL as Measured by 5-Level European Quality of Life (EuroQol)-5-dimension [EQ-5D-5L]
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Change in QoL as Measured by EQ-5D-5L
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Change in QoL as Measured by EQ-5D-5L
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: TTD in PF using the QLQ-C30 Physical Functioning Scale
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: TTD in PF using the QLQ-C30 Physical Functioning Scale
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: TTD in PF using the QLQ-C30 Physical Functioning Scale
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Change from baseline in the remaining items and domains of the EORTC QLQ-C30
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Change from baseline in the remaining items and domains of the EORTC QLQ-C30
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Change from baseline in the remaining items and domains of the EORTC QLQ-C30
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Change in Patient Global Impression of Change (PGIC) for General Lymphoma Symptoms
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Change in PGIC for General Lymphoma Symptoms
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm A2: Change in Patient Global Impression of Severity (PGIS) for General Lymphoma Symptoms
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm B: Change in PGIS for General Lymphoma Symptoms
timeFrame: Up to 10 Years
measure: Arm A1 vs Arm C: Change in PGIS for General Lymphoma Symptoms
timeFrame: Up to 10 Years
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Clinic Research /ID# 261596
state: California
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers - Boulder /ID# 261203
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health Service /ID# 261207
state: Delaware
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445
state: Florida
city: Orlando
country: United States
facility: Advent Health /ID# 261578
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute /ID# 260983
state: Florida
city: Coeur d'Alene
country: United States
facility: Beacon Cancer Care /ID# 260670
state: Idaho
city: Chicago
country: United States
facility: Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 259814
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists Of Central Illinois /ID# 272464
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care, PC /ID# 261526
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583
state: Indiana
city: Des Moines
country: United States
facility: University of Iowa Health Care /ID# 262132
state: Iowa
city: Louisville
country: United States
facility: University of Louisville Hospital /ID# 260544
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute - St. Matthews /ID# 261076
state: Kentucky
city: Westbrook
country: United States
facility: New England Cancer Specialists - Westbrook /ID# 260672
state: Maine
city: Baltimore
country: United States
facility: University of Maryland, Baltimore /ID# 259538
state: Maryland
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland /ID# 259476
state: Maryland
city: Chesterfield
country: United States
facility: St. Luke's Hospital - Chesterfield /ID# 260489
state: Missouri
city: Billings
country: United States
facility: Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006
state: Montana
city: Grand Island
country: United States
facility: Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Cancer Specialists - Omaha - Wright Street /ID# 262505
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center /ID# 261996
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico /ID# 261083
state: New Mexico
city: Albuquerque
country: United States
facility: Presbyterian Kaseman Hospital /ID# 262451
state: New Mexico
city: Rio Rancho
country: United States
facility: Presbyterian Rust Medical Center /ID# 262447
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology - Albany Cancer Center /ID# 261814
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai /ID# 259595
state: New York
city: Troy
country: United States
facility: New York Oncology Hematology /ID# 270208
state: New York
city: Westbury
country: United States
facility: Clinical Research Alliance, Inc. /ID# 261078
state: New York
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center /ID# 259740
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center /ID# 259741
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc - Blue Ash /ID# 261204
state: Ohio
city: Maumee
country: United States
facility: Taylor Cancer Research Center /ID# 260488
state: Ohio
city: Eugene
country: United States
facility: Oncology Associates of Oregon, P.C. /ID# 261816
state: Oregon
city: Charleston
country: United States
facility: MUSC Hollings Cancer Center /ID# 259604
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health /ID# 259602
state: South Carolina
city: Austin
country: United States
facility: Texas Oncology - Austin Midtown /ID# 261208
state: Texas
city: Dallas
country: United States
facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 261206
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center /ID# 260984
state: Texas
city: Houston
country: United States
facility: Oncology Consultants /ID# 268390
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research /ID# 260382
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Healthcare LDS Hospital /ID# 259759
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists - Fairfax /ID# 261205
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia /ID# 261592
state: Virginia
city: Olympia
country: United States
facility: Vista Oncology - East Olympia /ID# 261360
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Hospital & Medical Center /ID# 260549
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties - Tacoma /ID# 262133
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital /ID# 259320
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital /ID# 259321
state: New South Wales
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Center /ID# 260431
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital /ID# 261465
state: New South Wales
city: Douglas
country: Australia
facility: Townsville University Hospital /ID# 259323
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital /ID# 259326
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital /ID# 259329
state: Queensland
city: Frankston
country: Australia
facility: Peninsula Private Hospital /ID# 259325
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital /ID# 259324
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital /ID# 259319
state: Western Australia
city: Brasschaat
country: Belgium
facility: Algemeen Ziekenhuis klina /ID# 260324
state: Antwerpen
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 260311
state: Bruxelles-Capitale
city: Gent
country: Belgium
facility: UZ Gent /ID# 260312
state: Oost-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ-Delta /ID# 260313
state: West-Vlaanderen
city: Liege
country: Belgium
facility: Groupe Sante CHC - Clinique du MontLegia /ID# 260325
city: Pleven
country: Bulgaria
facility: UMHAT Dr Georgi Stranski EAD /ID# 260763
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 260685
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski /ID# 259277
city: Sofia
country: Bulgaria
facility: SHAT Hematologic Diseases /ID# 260457
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM) /ID# 260617
state: Quebec
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 259806
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University /ID# 260014
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center /ID# 260478
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University /ID# 260558
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 260795
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital /ID# 260137
state: Guangdong
city: Nanning
country: China
facility: Affiliated Cancer Hospital of Guangxi Medical University /ID# 260537
state: Guangxi
city: Zhengzhou
country: China
facility: People's Hospital of Henan Province /ID# 259619
state: Henan
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 259743
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital /ID# 260506
state: Hubei
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University /ID# 260507
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University /ID# 260556
state: Jiangxi
city: Shenyang
country: China
facility: The First Hospital of China Medical University /ID# 260217
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital /ID# 260808
state: Shandong
city: Shanghai
country: China
facility: Fudan University Cancer Hospital /ID# 260564
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 260015
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Cancer Hospital /ID# 259807
state: Tianjin
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 259616
state: Tianjin
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 260644
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Cancer hospital /ID# 259742
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University /ID# 260566
state: Zhejiang
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava /ID# 260452
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicka bolnica Merkur /ID# 260393
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 260456
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb /ID# 260364
state: Grad Zagreb
city: Rijeka
country: Croatia
facility: Klinicki bolnicki centar Rijeka /ID# 260455
state: Primorsko-goranska Zupanija
city: Split
country: Croatia
facility: Klinicki Bolnicki Centar (KBC) Split /ID# 260454
state: Splitsko-dalmatinska Zupanija
city: Zadar
country: Croatia
facility: Zadar General Hospital /ID# 260837
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové - Sokolská /ID# 260560
state: Hradec Kralove
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady /ID# 260572
city: Herning
country: Denmark
facility: Regionshospitalet Godstrup /ID# 260778
state: Midtjylland
city: Roskilde
country: Denmark
facility: Roskilde Sygehus /ID# 260780
state: Sjælland
city: Odense
country: Denmark
facility: Odense University Hospital /ID# 260777
state: Syddanmark
city: Vejle
country: Denmark
facility: Sygehus Lillebalt, Vejle /ID# 260781
state: Syddanmark
city: Nantes CEDEX 2
country: France
facility: Hopital Prive du Confluent /ID# 260596
state: Loire-Atlantique
city: Avignon
country: France
facility: Centre Hospitalier D'Avignon /ID# 260511
state: Provence-Alpes-Cote-d Azur
city: Pierre Benite CEDEX
country: France
facility: HCL - Hopital Lyon Sud /ID# 260508
state: Rhone
city: Le Mans CEDEX 9
country: France
facility: Centre Hospitalier du Mans /ID# 260510
state: Sarthe
city: Caen
country: France
facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 260875
city: Libourne
country: France
facility: CH Libourne - Hopital Robert Boulin /ID# 261478
city: Paris
country: France
facility: Hôpital Saint-Louis /ID# 260509
city: Strasbourg
country: France
facility: Clinique Sainte-Anne /ID# 261528
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe /ID# 260348
state: Baden-Wuerttemberg
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 260388
state: Hessen
city: Kassel
country: Germany
facility: Klinikum Kassel /ID# 260432
state: Hessen
city: Eschweiler
country: Germany
facility: St.-Antonius-Hospital /ID# 260520
state: Nordrhein-Westfalen
city: Ludwigshafen am Rhein
country: Germany
facility: Klinikum Ludwigshafen /ID# 260688
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universitaet /ID# 260425
city: Patras
country: Greece
facility: Olympion General Clinic /ID# 262395
state: Achaia
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 259708
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 260855
state: Attiki
city: Alexandroupolis
country: Greece
facility: General University Hospital of Alexandroupolis /ID# 260858
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 259709
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 260051
state: Gyor-Moson-Sopron
city: Szekszard
country: Hungary
facility: Tolna Varmegyei Balassa Janos Korhaz /ID# 260048
state: Tolna
city: Szombathely
country: Hungary
facility: Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 260050
state: Vas
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet /ID# 260052
city: Afula
country: Israel
facility: HaEmek Medical Center /ID# 259936
state: H_efa
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 259937
state: HaDarom
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 259938
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 259934
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 259933
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah /ID# 259935
state: Yerushalayim
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 268328
city: Candiolo
country: Italy
facility: Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 260889
state: Torino
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 260886
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 260888
city: Reggio Emilia
country: Italy
facility: AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 260744
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico /ID# 260891
city: Toyoake
country: Japan
facility: Fujita Health University Hospital /ID# 264679
state: Aichi
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital /ID# 266426
state: Ehime
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital /ID# 265680
state: Fukui
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center /ID# 265960
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 267861
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 264994
state: Fukushima
city: Fukuyama
country: Japan
facility: Chugoku Central Hospital /ID# 266520
state: Hiroshima
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital /ID# 265031
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital /ID# 266379
state: Hyogo
city: Hitachi
country: Japan
facility: Hitachi General Hospital /ID# 265676
state: Ibaraki
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital /ID# 264675
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center /ID# 265497
state: Kanagawa
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 267135
state: Okayama
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 266019
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 265038
state: Osaka
city: Bunkyo ku
country: Japan
facility: Tokyo Metropolitan Komagome Hospital /ID# 267692
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital /ID# 266422
state: Tokyo
city: Ube
country: Japan
facility: Yamaguchi University Hospital /ID# 265619
state: Yamaguchi
city: Chuo
country: Japan
facility: University of Yamanashi Hospital /ID# 264677
state: Yamanashi
city: Aomori
country: Japan
facility: Aomori Prefectural Central Hospital /ID# 265692
city: Chiba
country: Japan
facility: Chiba Cancer Center /ID# 267316
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 260009
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 260007
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 260010
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 260008
state: Seoul Teugbyeolsi
city: Bergen op Zoom
country: Netherlands
facility: Bravis Ziekenhuis /ID# 259055
state: Noord-Brabant
city: Tilburg
country: Netherlands
facility: Elisabeth Tweesteden Ziekenhuis /ID# 261239
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Olvg /Id# 259543
state: Noord-Holland
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis /ID# 259053
state: Utrecht
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis /ID# 261220
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum /ID# 259049
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 259052
state: Zuid-Holland
city: Arnhem
country: Netherlands
facility: Rijnstate /ID# 261219
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 259051
city: Grafton
country: New Zealand
facility: Auckland City Hospital /ID# 259330
state: Auckland
city: Takapuna
country: New Zealand
facility: North Shore Hospital /ID# 260824
state: Auckland
city: Lodz
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 260633
state: Lodzkie
city: Krakow
country: Poland
facility: Pratia MCM Krakow /ID# 260075
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. M. Sklodowskiej /ID# 260861
state: Mazowieckie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 260170
state: Swietokrzyskie
city: Lisbon
country: Portugal
facility: Fundacao Champalimaud /ID# 259652
state: Lisboa
city: Vila Nova de Gaia
country: Portugal
facility: Unidade Local de Saude de Gaia/Espinho, EPE /ID# 259655
state: Porto
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE /ID# 259650
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 259649
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials, LLC /ID# 260265
city: San Juan
country: Puerto Rico
facility: Auxilio Mutuo Cancer Center /ID# 260262
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute /ID# 260296
state: Bucuresti
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof Dr I Chiricuta /ID# 259704
state: Cluj
city: Jassi
country: Romania
facility: Institutul Regional de Oncologie /ID# 259697
state: Iasi
city: Bucharest
country: Romania
facility: Spitalul Clinic Coltea /ID# 259699
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara /ID# 260900
state: Beograd
city: Belgrade
country: Serbia
facility: University Clinical Center Serbia /ID# 259271
state: Beograd
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac /ID# 259274
state: Sumadijski Okrug
city: Sremska Kamenica
country: Serbia
facility: Institute for Oncology of Vojvodina /ID# 260223
state: Vojvodina
city: Novi Sad
country: Serbia
facility: University Clinical Center Vojvodina /ID# 259272
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav /ID# 260638
state: Bratislavsky Kraj
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin /ID# 260631
state: Zilinsky Kraj
city: Pretoria
country: South Africa
facility: Alberts Cellular Therapy /ID# 260514
state: Gauteng
city: Kuilsrivier
country: South Africa
facility: Haemalife Inc. /ID# 260513
state: Western Cape
city: Badalona
country: Spain
facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 260495
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 261439
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla /ID# 260497
state: Cantabria
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona /ID# 260496
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 260490
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 260492
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 260498
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara /ID# 260502
city: Madrid
country: Spain
facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 261512
city: Madrid
country: Spain
facility: MD Anderson Madrid /ID# 260500
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca /ID# 260491
city: Boras
country: Sweden
facility: Sodra Alvsborgs sjukhus /ID# 261168
state: Vastra Gotalands Lan
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 260341
state: Taipei
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 260357
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital /ID# 260361
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 260363
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi /ID# 259803
city: Kocaeli
country: Turkey
facility: Kocaeli University Med Faculty /ID# 259717
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi /ID# 259713
city: Plymouth
country: United Kingdom
facility: Derriford Hospital and the Royal Eye Infirmary /ID# 262671
state: Devon
city: London
country: United Kingdom
facility: Hammersmith Hospital /ID# 261124
state: England
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital /ID# 269708
state: Hampshire
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust /ID# 260466
state: West Yorkshire
city: Manchester
country: United Kingdom
facility: The Christie Hospital /ID# 260463
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260792
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: