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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04628494




Registration number
NCT04628494
Ethics application status
Date submitted
9/11/2020
Date registered
13/11/2020

Titles & IDs
Public title
A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL
Scientific 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)
Secondary ID [1] 0 0
2020-003016-27
Secondary ID [2] 0 0
GCT3013-05
Universal Trial Number (UTN)
Trial acronym
EPCORE DLBCL-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - Epcoritamab
Treatment: Drugs - Investigator's Choice Chemotherapy

Experimental: Epcoritamab (GEN3013; DuoBody®CD3xCD20) - Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met

Active comparator: Investigator's choice of chemotherapy - 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


Treatment: Other: Epcoritamab
Following mandatory pre-medication subject will be administered epcoritamab as a subcutaneous injection.

Treatment: Drugs: Investigator's Choice Chemotherapy
Following mandatory pre-medication subject will be administered intravenously either BR or R-GemOx.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
throughout the study and up to 5 years following the last patient first dose
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
throughout the study and up to 5 years following the last patient first dose
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
throughout the study and up to 5 years following the last patient first dose
Secondary outcome [3] 0 0
Complete Response (CR)
Timepoint [3] 0 0
throughout the study and up to 5 years following the last patient first dose
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
throughout the study and up to 5 years following the last patient first dose
Secondary outcome [5] 0 0
Time to Response (TTR)
Timepoint [5] 0 0
throughout the study and up to 5 years following the last patient first dose
Secondary outcome [6] 0 0
Rate and duration of minimal residual disease (MRD) negative status
Timepoint [6] 0 0
up to 5 years after randomization of the last patient
Secondary outcome [7] 0 0
Time to next anti-lymphoma therapy (TTNT)
Timepoint [7] 0 0
throughout the study and up to 5 years following the last patient first dose
Secondary outcome [8] 0 0
Incidence and severity of adverse events (AEs)
Timepoint [8] 0 0
throughout the study and up to 5 years following the last patient first dose
Secondary outcome [9] 0 0
Incidence and severity of changes in laboratory values
Timepoint [9] 0 0
throughout the study and up to 5 years following the last patient first dose
Secondary outcome [10] 0 0
Incidence of dose interruptions and delays
Timepoint [10] 0 0
throughout the study and up to 5 years following the last patient first dose
Secondary outcome [11] 0 0
Anti-epcoritamab antibody response
Timepoint [11] 0 0
throughout the study and up to 5 years following the last patient first dose
Secondary outcome [12] 0 0
Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Timepoint [12] 0 0
throughout the study and up to 5 years following the last patient first dose

Eligibility
Key inclusion criteria
Main

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2028
Actual
Sample size
Target
552
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Peninsula Private Hospital Clinical Trials Unit - Frankston
Recruitment hospital [4] 0 0
Icon Cancer Centre Corporate Office - South Brisbane
Recruitment hospital [5] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Frankston
Recruitment postcode(s) [4] 0 0
- South Brisbane
Recruitment postcode(s) [5] 0 0
- Waratah
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Indiana
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United States of America
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Kentucky
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United States of America
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Michigan
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Utah
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Austria
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Linz
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Austria
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Salzburg
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Belgium
State/province [9] 0 0
Antwerp
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Belgium
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Brugge
Country [11] 0 0
Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Jette
Country [14] 0 0
Belgium
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La Louvière
Country [15] 0 0
Belgium
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Leuven
Country [16] 0 0
Belgium
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Sint-Niklaas
Country [17] 0 0
Belgium
State/province [17] 0 0
Turnhout
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Canada
State/province [18] 0 0
Québec City
Country [19] 0 0
China
State/province [19] 0 0
Baoding
Country [20] 0 0
China
State/province [20] 0 0
Beijing
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China
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Changchun
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China
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Chengdu
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China
State/province [23] 0 0
Dalian
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China
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Guangdong
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China
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Guangxi
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China
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Hangzhou
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China
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Hubei
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China
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Hunan
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China
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Nanchang
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China
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Qingdao
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China
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Shanxi
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China
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Shenyang
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China
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Shenzhen
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China
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Suzhou
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China
State/province [35] 0 0
Tianjin
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China
State/province [36] 0 0
Wuhan
Country [37] 0 0
China
State/province [37] 0 0
Yantai
Country [38] 0 0
China
State/province [38] 0 0
Zhengzhou
Country [39] 0 0
China
State/province [39] 0 0
Zhenjiang
Country [40] 0 0
Denmark
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Aalborg
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Denmark
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Aarhus
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Denmark
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Roskilde
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Denmark
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Vejle
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Finland
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Helsinki
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Finland
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Oulu
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France
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Amiens
Country [47] 0 0
France
State/province [47] 0 0
Bayonne
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France
State/province [48] 0 0
Brest
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France
State/province [49] 0 0
Caen
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France
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La Rochelle
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France
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Limoges
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Lyon
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Marseille
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Nantes
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France
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Nice
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France
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Paris
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France
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Pessac
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France
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Pierre-Bénite
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France
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Poitiers
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France
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Pontoise
Country [61] 0 0
France
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Quimper
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France
State/province [62] 0 0
Rouen
Country [63] 0 0
France
State/province [63] 0 0
Tours
Country [64] 0 0
Germany
State/province [64] 0 0
Cologne
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Germany
State/province [65] 0 0
Essen
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Germany
State/province [66] 0 0
Kiel
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Germany
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Würzburg
Country [68] 0 0
Hungary
State/province [68] 0 0
Budapest
Country [69] 0 0
Hungary
State/province [69] 0 0
Debrecen
Country [70] 0 0
Hungary
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Eger
Country [71] 0 0
Hungary
State/province [71] 0 0
Gyor
Country [72] 0 0
Hungary
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Nyiregyhaza
Country [73] 0 0
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State/province [73] 0 0
Pécs
Country [74] 0 0
Hungary
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Szeged
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Szekesfehervar
Country [76] 0 0
Israel
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Haifa
Country [77] 0 0
Israel
State/province [77] 0 0
Jerusalem
Country [78] 0 0
Israel
State/province [78] 0 0
Tel Aviv
Country [79] 0 0
Italy
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Bari
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Italy
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Bergamo
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Italy
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Brescia
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Italy
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Meldola
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Italy
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Milan
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Italy
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Novara
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Italy
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Pavia
Country [86] 0 0
Italy
State/province [86] 0 0
Ravenna
Country [87] 0 0
Italy
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Rome
Country [88] 0 0
Italy
State/province [88] 0 0
San Giovanni Rotondo
Country [89] 0 0
Italy
State/province [89] 0 0
Trieste
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Italy
State/province [90] 0 0
Venezia
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Japan
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Fukuoka
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Japan
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Fukushima
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Fukuyama
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Hokkaido
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Japan
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Kashiwa
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Kyoto
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Matsuyama
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Japan
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Mie
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Nagoya
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Okayama
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Sendai
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Tokyo
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Toyoake
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Japan
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Yamagata
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Japan
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Osaka-sayama
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Korea, Republic of
State/province [106] 0 0
Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
State/province [108] 0 0
Geumam
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Korea, Republic of
State/province [109] 0 0
Seoul
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Korea, Republic of
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Ulsan
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Netherlands
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Arnhem
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Netherlands
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Breda
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Netherlands
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Dordrecht
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Netherlands
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Goes
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Netherlands
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Roosendaal
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Rotterdam
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Norway
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Oslo
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Norway
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Trondheim
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Poland
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Gdansk
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Katowice
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Poland
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Kraków
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Poland
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Skorzewo
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Poland
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Wroclaw
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Poland
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Lódz
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Russian Federation
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Kazan
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Russian Federation
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Leningrad
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Saint Petersburg
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Singapore
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Kent Ridge
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Singapore
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Singapore
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Badalona
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Barcelona
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Spain
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Cadiz
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Spain
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Cáceres,
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Spain
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Cáceres
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Spain
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Córdoba
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Santander
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Spain
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Sevilla
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Sweden
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Stockholm
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Taiwan
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Kaohsiung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Tekirdag
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Turkey
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Trabzon
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United Kingdom
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Birmingham
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United Kingdom
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London
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United Kingdom
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Norwich
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United Kingdom
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Nottingham
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United Kingdom
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Plymouth
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United Kingdom
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Southampton
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United Kingdom
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Sutton
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United Kingdom
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genmab
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04628494