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A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL (EPCORE DLBCL-1)

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Epcoritamab
Investigator's Choice Chemotherapy
Sponsored by
Genmab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring double-hit DLBCL, triple-hit DLBCL, follicular grade 3B, transformed DLBCL, T-cell histiocytes-rich large B cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  1. Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since lymphoma diagnosis

  2. One of the confirmed histologies below with CD20-positivity:

    1. DLBCL, NOS, including de novo or histologically transformed from FL
    2. "Double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL
    3. FL Grade 3B
    4. T-cell/histiocyte-rich large B-cell lymphoma
  3. ECOG PS score of 0-2
  4. Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening
  5. Patients must have detectable disease by PET scan and measurable by CT scan or MRI
  6. Acceptable renal and liver function
  7. Life expectancy >2 months on SOC treatment

Main Exclusion Criteria:

  1. Primary Central Nervous System (CNS) tumor or known CNS involvement
  2. Any prior therapy with a bispecific antibody targeting CD3 and CD20
  3. Major surgery within 4 weeks prior to randomization
  4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
  5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
  6. ASCT within 100 days of randomization
  7. Treatment with CAR-T therapy within 100 days prior to randomization
  8. Seizure disorder requiring anti-epileptic therapy
  9. Clinically significant cardiac disease

Sites / Locations

  • Indiana Blood and Marrow Transplantation
  • Community Health Network Cancer Center North
  • Henry Ford Health System
  • Wake Forest Baptist Health
  • TriHealth Cancer Institute- Good Samaritan Hospital
  • LDS Hospital
  • Flinders Medical Centre
  • Concord Repatriation General Hospital
  • Peninsula Private Hospital Clinical Trials Unit
  • Icon Cancer Centre Corporate Office
  • Calvary Mater Newcastle
  • Westmead Hospital
  • Ordensklinikum Linz Barmherzige Schwestern
  • Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU
  • ZNA Middelheim
  • AZ Sint-Jan
  • Institut Jules Bordet
  • Universitair Ziekenhuis Gent
  • UZ Brussel
  • Universitair Ziekenhuis gasthuisberg Leuven
  • AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme
  • AZ Turnhout, Campus Sint-Elisabeth
  • CHU de Quebec-Universite Laval
  • Beijing Cancer Hospital
  • Beijing Tongren Hospital, Capital Medical University
  • The First Hospital of Jilin University
  • West China Hospital, Sichuan University
  • The Second Hospital of Dalian Medical University
  • Guangdong Provincial Peoples Hospital
  • Guangxi Medical University Affiliated Tumor Hospital
  • The First Affiliated Hospital, Zhejiang University School of Medicine
  • Hubei Cancer Hospital
  • Hunan Cancer Hospital
  • The First Affiliated Hospital of Nanchang University
  • Qingdao Central Hospital
  • Shanxi Provincial Cancer Hospital
  • Shengjing Hospital of China Medical University
  • Shenzhen Peoples Hospital
  • The First Affiliated Hospital of Soochow University
  • Tianjin Medical University Cancer Institute and Hospital
  • EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Henan Cancer Hospital
  • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Aalborg Universitetshospital
  • Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116
  • Clinical Research Unit, Roskilde Sygehus
  • Vejle Hospital
  • HUS Cancer Center/ Clinical Trial Unit
  • Oulu university hospital, Department of hematology
  • Audrey ALEME
  • Centre Hospitalier de la Côte Basque
  • CHRU de Brest - Hospital Morvan
  • CHU Caen - IHBN
  • Groupe Hospitalier de La Rochelle
  • CHU de LIMOGES
  • Centre Léon Bérard
  • Hopital de la Conception APHM
  • CHU de Nantes - Hôtel Dieu
  • Centre Antoine Lacassagne
  • Clinique Victor Hugo
  • Hôpital Saint-Louis
  • CHU de Bordeaux Hôpital Haut-Lévêque
  • Centre Hospitalier Lyon Sud
  • CHU de Poitiers - Hôpital la Milétrie
  • Ch Cornouaille
  • Centre Henri Becquerel
  • CHRU Tours Hôpital Bretonneau
  • Uniklinik Köln, Klinik I für Innere Medizin, CIO Gebäude 70, 5.094
  • Universitaetsklinikum Essen
  • Universitätsklinikum Schleswig-Holstein Medizinische Klinik II Hämatologie und Onkologie
  • Universitätsklinikum Würzburg
  • National Institute of Oncology
  • Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika
  • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia
  • Belgyógyászati osztály Markhot Ferenc Kórház
  • Petz Aladar Egyetemi Oktato Korhaz
  • Josa Andras Teaching Hospital, Hematology Dept
  • University of Pecs 1st. Internal medicine Clinic Dept. Hematology
  • Szegedi Tudományegyetem II. sz. Belgyogyaszat, Hematologia
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Bnai Zion Medical Center
  • Hadassah University Hospital
  • Shaare Zedek Medical Center
  • Sourasky Medical Center
  • Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi)
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
  • Istituto Oncologico Europeo
  • San Raffaele Hospital
  • Azienda Ospedaliero - Universitaria Maggiore delle Carita SCDU Ematologia building C
  • Ospedale Santa Maria delle Croci
  • Azienda Ospedaliera Universitaria Policlinico Umberto I Università di Roma La Sapienza, Dip Med Tra
  • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Ospedale Maggiore di Trieste
  • SC di Ematologia - AON SS Antonio e Biagio e Cesare Arrigo
  • Kyushu University Hospital
  • Fukushima Medical University Hospital
  • Chugoku Central Hospital
  • Hokkaido University Hospital
  • National Cancer Center Hospital East
  • Kyoto University Medical Hospital
  • Matsuyama Red Cross Hospital
  • Mie University Hospital
  • Japanese Red Cross Nagoya Daini Hospital
  • NHO Nagoya Medical Center
  • Okayama University Hospital
  • Tohoku University Hospital
  • Keio University Hospital
  • National Cancer Center Hospital
  • Tokai University Hospital
  • Fujita Health University Hospital
  • Yamagata University Hospital
  • Kindai University Hospital
  • Dong-A University Hospital
  • Pusan National University Hospital
  • Pusan National University Hosptial
  • Keimyung University Dongsan Hospital
  • Chonbuk National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Ulsan University Hospital
  • Rijnstate Arnhem
  • Amphia Ziekenhuis, Interne Geneeskunde, Oncologie. Route 43
  • Albert Schweitzer Ziekenhuis
  • Admiraal de Ruyter Ziekenhuis
  • Bravis Ziekenhuis
  • Erasmus MC
  • Franciscus Gasthuis And Vlietland
  • Oslo University Hospital location Radium hospital
  • St. Olavs Hospital HF
  • Pratia Onkologia Katowice
  • Pratia MCM Kraków
  • Centrum Medyczne Pratia Poznan
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Instytut Centrum Zdrowia Matki Polki
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
  • State Autonomous Institution of Healthcare Republican Clinical Oncological Dispensary of the Ministr
  • State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital
  • Federal State Budgetary Institution of Science
  • Federal State Budgetary Institution
  • State Budgetary Institution of Healthcare of Nizhniy Novgorod region, 1st inpatient facility, 5th fl
  • Federal State Budgetary Institution V.A. Almazov National Medical Research Center of the Ministry of
  • Clinical Trials and Research Centre
  • ICO Badalona - Hospital Universitari Germans Trias i Pujol
  • ICO l'Hospitalet - Hospital Duran i Reynals
  • Hospita Universitario Puerta Del Mar
  • Hospital San Pedro de Alcántara
  • Hospital San Pedro de Alcántara
  • Hospital Universitario Reina Sofía
  • Hospital Arnau de Vilanova
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Fundacion Jimenez Diaz
  • Hospital Universitario Ramon y Cajal
  • Md Anderson Cancer Center
  • Hospital Universitario de Salamanca
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Universitario Virgen De Valme
  • Hospital Universitario Virgen del Rocío
  • Hospital Universitario Virgen Macarena
  • Karolinska university Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Ankara University Medical Faculty
  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
  • Gazi University Medical Faculty
  • Amerikan Hospital
  • Iqvia Tibbi Istatistik
  • Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi
  • Istanbul University Medical Faculty
  • Dokuz Eylul University Medical Faculty
  • Ege University Medical Faculty
  • Tekirdag Namik Kemal University
  • Karadeniz Technical University
  • Haematology - University Hospitals Birmingham NHS Foundation Trust
  • Guys and St Thomas NHS Foundation Trust
  • Hammersmith Hospital
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • Nottingham University Hospitals NHS Trust
  • Derriford Hospital
  • University Hospital Southampton
  • Royal Marsden NHS Foundation Trust (Sutton)
  • Royal Cornwall Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Epcoritamab (GEN3013; DuoBody®CD3xCD20)

Investigator's choice of chemotherapy

Arm Description

Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met

R-GemOx will be administrated in Cycles of 28 days until maximum cycles completion or any of the discontinuation criteria is met BR will be administrated in Cycles of 21 days until maximum cycles completion or any of the discontinuation criteria is met

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS is calculated as the time from first dose to death date or last date known to be alive.

Secondary Outcome Measures

Progression Free Survival (PFS)
PFS is calculated as the time from randomization to the date of disease progression or death, whichever is earlier. Progression is determined by the Lugano criteria and LYRIC.
Overall Response Rate (ORR)
ORR is calculated as the proportion of subjects achieving a complete response or partial response. Response is determined by the Lugano criteria and LYRIC.
Complete Response (CR)
CR rate is calculated as the proportion of subjects achieving a complete response. Response is determined by the Lugano criteria and LYRIC.
Duration of Response (DOR)
DOR is calculated as the time from initial response (CR or PR) to date of progression or death, whichever is earlier. Response and progression are determined by the Lugano criteria and LYRIC.
Time to Response (TTR)
TTR is calculated as the time from randomization to date of initial response (CR or PR) among responders only. Response is determined by the Lugano criteria and LYRIC.
Rate and duration of minimal residual disease (MRD) negative status
Compare other measures of efficacy to SOC - MRD negativity rate, defined as the proportion of subjects who have at least one negative MRD sample at any time point prior to start of subsequent anti-lymphoma therapy
Time to next anti-lymphoma therapy (TTNT)
TTNT is calculated as the time from randomization to date of initiation of new anti-lymphoma therapy.
Incidence and severity of adverse events (AEs)
identify patterns of incidence in adverse events, with particular emphasis on pre-defined adverse events of special interest
Incidence and severity of changes in laboratory values
Clinical laboratory parameters assessed: hematology, chemistry, coagulation, tumor lysis, immunoglobulins, and urinalyses
Incidence of dose interruptions and delays
calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall
Anti-epcoritamab antibody response
calculate incidence of antibody response to epcoritamab in relation to dosing
Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
monitor change from baseline in health-related quality of life over time and in relation to treatment

Full Information

First Posted
November 9, 2020
Last Updated
August 4, 2023
Sponsor
Genmab
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04628494
Brief Title
A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL
Acronym
EPCORE DLBCL-1
Official Title
A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
April 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab
Collaborators
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The drug that will be investigated in the study is an antibody, epcoritamab, also known as EPKINLY™ and GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator's choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT
Detailed Description
The trial is an open label, multi-center, global phase 3 randomized trial of epcoritamab, GEN3013. The goal of this randomized trial is to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy, in patients with relapsed, refractory diffuse large B-Cell Lymphoma who have failed or are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). No change in chemotherapy is permitted for participants during the treatment phase of the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma
Keywords
double-hit DLBCL, triple-hit DLBCL, follicular grade 3B, transformed DLBCL, T-cell histiocytes-rich large B cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
552 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epcoritamab (GEN3013; DuoBody®CD3xCD20)
Arm Type
Experimental
Arm Description
Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met
Arm Title
Investigator's choice of chemotherapy
Arm Type
Active Comparator
Arm Description
R-GemOx will be administrated in Cycles of 28 days until maximum cycles completion or any of the discontinuation criteria is met BR will be administrated in Cycles of 21 days until maximum cycles completion or any of the discontinuation criteria is met
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Intervention Description
Following mandatory pre-medication subject will be administered epcoritamab as a subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Investigator's Choice Chemotherapy
Other Intervention Name(s)
BR or R-GemOx
Intervention Description
Following mandatory pre-medication subject will be administered intravenously either BR or R-GemOx.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is calculated as the time from first dose to death date or last date known to be alive.
Time Frame
throughout the study and up to 5 years following the last patient first dose
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is calculated as the time from randomization to the date of disease progression or death, whichever is earlier. Progression is determined by the Lugano criteria and LYRIC.
Time Frame
throughout the study and up to 5 years following the last patient first dose
Title
Overall Response Rate (ORR)
Description
ORR is calculated as the proportion of subjects achieving a complete response or partial response. Response is determined by the Lugano criteria and LYRIC.
Time Frame
throughout the study and up to 5 years following the last patient first dose
Title
Complete Response (CR)
Description
CR rate is calculated as the proportion of subjects achieving a complete response. Response is determined by the Lugano criteria and LYRIC.
Time Frame
throughout the study and up to 5 years following the last patient first dose
Title
Duration of Response (DOR)
Description
DOR is calculated as the time from initial response (CR or PR) to date of progression or death, whichever is earlier. Response and progression are determined by the Lugano criteria and LYRIC.
Time Frame
throughout the study and up to 5 years following the last patient first dose
Title
Time to Response (TTR)
Description
TTR is calculated as the time from randomization to date of initial response (CR or PR) among responders only. Response is determined by the Lugano criteria and LYRIC.
Time Frame
throughout the study and up to 5 years following the last patient first dose
Title
Rate and duration of minimal residual disease (MRD) negative status
Description
Compare other measures of efficacy to SOC - MRD negativity rate, defined as the proportion of subjects who have at least one negative MRD sample at any time point prior to start of subsequent anti-lymphoma therapy
Time Frame
up to 5 years after randomization of the last patient
Title
Time to next anti-lymphoma therapy (TTNT)
Description
TTNT is calculated as the time from randomization to date of initiation of new anti-lymphoma therapy.
Time Frame
throughout the study and up to 5 years following the last patient first dose
Title
Incidence and severity of adverse events (AEs)
Description
identify patterns of incidence in adverse events, with particular emphasis on pre-defined adverse events of special interest
Time Frame
throughout the study and up to 5 years following the last patient first dose
Title
Incidence and severity of changes in laboratory values
Description
Clinical laboratory parameters assessed: hematology, chemistry, coagulation, tumor lysis, immunoglobulins, and urinalyses
Time Frame
throughout the study and up to 5 years following the last patient first dose
Title
Incidence of dose interruptions and delays
Description
calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall
Time Frame
throughout the study and up to 5 years following the last patient first dose
Title
Anti-epcoritamab antibody response
Description
calculate incidence of antibody response to epcoritamab in relation to dosing
Time Frame
throughout the study and up to 5 years following the last patient first dose
Title
Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Description
monitor change from baseline in health-related quality of life over time and in relation to treatment
Time Frame
throughout the study and up to 5 years following the last patient first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since lymphoma diagnosis One of the confirmed histologies below with CD20-positivity: DLBCL, NOS, including de novo or histologically transformed from FL "Double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL FL Grade 3B T-cell/histiocyte-rich large B-cell lymphoma ECOG PS score of 0-2 Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening Patients must have detectable disease by PET scan and measurable by CT scan or MRI Acceptable renal and liver function Life expectancy >2 months on SOC treatment Main Exclusion Criteria: Primary Central Nervous System (CNS) tumor or known CNS involvement Any prior therapy with a bispecific antibody targeting CD3 and CD20 Major surgery within 4 weeks prior to randomization Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization ASCT within 100 days of randomization Treatment with CAR-T therapy within 100 days prior to randomization Seizure disorder requiring anti-epileptic therapy Clinically significant cardiac disease
Facility Information:
Facility Name
Indiana Blood and Marrow Transplantation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Community Health Network Cancer Center North
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Henry Ford Health System
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
TriHealth Cancer Institute- Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45247
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Flinders Medical Centre
City
Bedford Park
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
Country
Australia
Facility Name
Peninsula Private Hospital Clinical Trials Unit
City
Frankston
Country
Australia
Facility Name
Icon Cancer Centre Corporate Office
City
South Brisbane
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
Country
Australia
Facility Name
Ordensklinikum Linz Barmherzige Schwestern
City
Linz
Country
Austria
Facility Name
Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU
City
Salzburg
Country
Austria
Facility Name
ZNA Middelheim
City
Antwerp
Country
Belgium
Facility Name
AZ Sint-Jan
City
Brugge
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
Country
Belgium
Facility Name
UZ Brussel
City
Jette
Country
Belgium
Facility Name
Universitair Ziekenhuis gasthuisberg Leuven
City
Leuven
Country
Belgium
Facility Name
AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme
City
Sint-Niklaas
Country
Belgium
Facility Name
AZ Turnhout, Campus Sint-Elisabeth
City
Turnhout
Country
Belgium
Facility Name
CHU de Quebec-Universite Laval
City
Québec City
Country
Canada
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Beijing Tongren Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
Country
China
Facility Name
Guangdong Provincial Peoples Hospital
City
Guangdong
Country
China
Facility Name
Guangxi Medical University Affiliated Tumor Hospital
City
Guangxi
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
Country
China
Facility Name
Hubei Cancer Hospital
City
Hubei
Country
China
Facility Name
Hunan Cancer Hospital
City
Hunan
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
Qingdao Central Hospital
City
Qingdao
Country
China
Facility Name
Shanxi Provincial Cancer Hospital
City
Shanxi
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
Country
China
Facility Name
Shenzhen Peoples Hospital
City
Shenzhen
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
Country
China
Facility Name
EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Zhenjiang
Country
China
Facility Name
Aalborg Universitetshospital
City
Aalborg
Country
Denmark
Facility Name
Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116
City
Aarhus
Country
Denmark
Facility Name
Clinical Research Unit, Roskilde Sygehus
City
Roskilde
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
Country
Denmark
Facility Name
HUS Cancer Center/ Clinical Trial Unit
City
Helsinki
Country
Finland
Facility Name
Oulu university hospital, Department of hematology
City
Oulu
Country
Finland
Facility Name
Audrey ALEME
City
Amiens
Country
France
Facility Name
Centre Hospitalier de la Côte Basque
City
Bayonne
Country
France
Facility Name
CHRU de Brest - Hospital Morvan
City
Brest
Country
France
Facility Name
CHU Caen - IHBN
City
Caen
Country
France
Facility Name
Groupe Hospitalier de La Rochelle
City
La Rochelle
Country
France
Facility Name
CHU de LIMOGES
City
Limoges
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Hopital de la Conception APHM
City
Marseille
Country
France
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Facility Name
Clinique Victor Hugo
City
Paris
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
Country
France
Facility Name
CHU de Bordeaux Hôpital Haut-Lévêque
City
Pessac
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
Country
France
Facility Name
CHU de Poitiers - Hôpital la Milétrie
City
Poitiers
Country
France
Facility Name
Ch Cornouaille
City
Quimper
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
CHRU Tours Hôpital Bretonneau
City
Tours
Country
France
Facility Name
Uniklinik Köln, Klinik I für Innere Medizin, CIO Gebäude 70, 5.094
City
Cologne
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein Medizinische Klinik II Hämatologie und Onkologie
City
Kiel
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
Country
Germany
Facility Name
National Institute of Oncology
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia
City
Debrecen
Country
Hungary
Facility Name
Belgyógyászati osztály Markhot Ferenc Kórház
City
Eger
Country
Hungary
Facility Name
Petz Aladar Egyetemi Oktato Korhaz
City
Győr
Country
Hungary
Facility Name
Josa Andras Teaching Hospital, Hematology Dept
City
Nyiregyhaza
Country
Hungary
Facility Name
University of Pecs 1st. Internal medicine Clinic Dept. Hematology
City
Pécs
Country
Hungary
Facility Name
Szegedi Tudományegyetem II. sz. Belgyogyaszat, Hematologia
City
Szeged
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Szekesfehervar
Country
Hungary
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi)
City
Bergamo
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
City
Brescia
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
City
Meldola
Country
Italy
Facility Name
Istituto Oncologico Europeo
City
Milan
Country
Italy
Facility Name
San Raffaele Hospital
City
Milan
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Maggiore delle Carita SCDU Ematologia building C
City
Novara
Country
Italy
Facility Name
Ospedale Santa Maria delle Croci
City
Ravenna
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Umberto I Università di Roma La Sapienza, Dip Med Tra
City
Rome
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Ospedale Maggiore di Trieste
City
Trieste
Country
Italy
Facility Name
SC di Ematologia - AON SS Antonio e Biagio e Cesare Arrigo
City
Venezia
Country
Italy
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
Country
Japan
Facility Name
Chugoku Central Hospital
City
Fukuyama
Country
Japan
Facility Name
Hokkaido University Hospital
City
Hokkaido
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
Country
Japan
Facility Name
Kyoto University Medical Hospital
City
Kyoto
Country
Japan
Facility Name
Matsuyama Red Cross Hospital
City
Matsuyama
Country
Japan
Facility Name
Mie University Hospital
City
Mie
Country
Japan
Facility Name
Japanese Red Cross Nagoya Daini Hospital
City
Nagoya
Country
Japan
Facility Name
NHO Nagoya Medical Center
City
Nagoya
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
Country
Japan
Facility Name
Tokai University Hospital
City
Tokyo
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata
Country
Japan
Facility Name
Kindai University Hospital
City
Ōsaka-sayama
Country
Japan
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Pusan National University Hosptial
City
Busan
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Geumam
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Facility Name
Rijnstate Arnhem
City
Arnhem
Country
Netherlands
Facility Name
Amphia Ziekenhuis, Interne Geneeskunde, Oncologie. Route 43
City
Breda
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
Country
Netherlands
Facility Name
Admiraal de Ruyter Ziekenhuis
City
Goes
Country
Netherlands
Facility Name
Bravis Ziekenhuis
City
Roosendaal
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Facility Name
Franciscus Gasthuis And Vlietland
City
Rotterdam
Country
Netherlands
Facility Name
Oslo University Hospital location Radium hospital
City
Oslo
Country
Norway
Facility Name
St. Olavs Hospital HF
City
Trondheim
Country
Norway
Facility Name
Pratia Onkologia Katowice
City
Katowice
Country
Poland
Facility Name
Pratia MCM Kraków
City
Kraków
Country
Poland
Facility Name
Centrum Medyczne Pratia Poznan
City
Skorzewo
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wrocław
Country
Poland
Facility Name
Instytut Centrum Zdrowia Matki Polki
City
Łódź
Country
Poland
Facility Name
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
City
Łódź
Country
Poland
Facility Name
State Autonomous Institution of Healthcare Republican Clinical Oncological Dispensary of the Ministr
City
Kazan
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital
City
Leningrad
Country
Russian Federation
Facility Name
Federal State Budgetary Institution of Science
City
Moscow
Country
Russian Federation
Facility Name
Federal State Budgetary Institution
City
Moscow
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare of Nizhniy Novgorod region, 1st inpatient facility, 5th fl
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Federal State Budgetary Institution V.A. Almazov National Medical Research Center of the Ministry of
City
Saint Petersburg
Country
Russian Federation
Facility Name
Clinical Trials and Research Centre
City
Singapore
Country
Singapore
Facility Name
ICO Badalona - Hospital Universitari Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
ICO l'Hospitalet - Hospital Duran i Reynals
City
Barcelona
Country
Spain
Facility Name
Hospita Universitario Puerta Del Mar
City
Cadiz
Country
Spain
Facility Name
Hospital San Pedro de Alcántara
City
Cáceres,
Country
Spain
Facility Name
Hospital San Pedro de Alcántara
City
Cáceres
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Lleida
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
Md Anderson Cancer Center
City
Madrid
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital Universitario Virgen De Valme
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
Country
Spain
Facility Name
Karolinska university Hospital
City
Stockholm
Country
Sweden
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Ankara University Medical Faculty
City
Ankara
Country
Turkey
Facility Name
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
City
Ankara
Country
Turkey
Facility Name
Gazi University Medical Faculty
City
Ankara
Country
Turkey
Facility Name
Amerikan Hospital
City
Istanbul
Country
Turkey
Facility Name
Iqvia Tibbi Istatistik
City
Istanbul
Country
Turkey
Facility Name
Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi
City
Istanbul
Country
Turkey
Facility Name
Istanbul University Medical Faculty
City
Istanbul
Country
Turkey
Facility Name
Dokuz Eylul University Medical Faculty
City
İzmir
Country
Turkey
Facility Name
Ege University Medical Faculty
City
İzmir
Country
Turkey
Facility Name
Tekirdag Namik Kemal University
City
Tekirdağ
Country
Turkey
Facility Name
Karadeniz Technical University
City
Trabzon
Country
Turkey
Facility Name
Haematology - University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust
City
Norwich
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
Facility Name
University Hospital Southampton
City
Southampton
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust (Sutton)
City
Sutton
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL

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