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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
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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)
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Secondary ID [1]
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0
2020-003016-27
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Secondary ID [2]
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GCT3013-05
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Universal Trial Number (UTN)
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Trial acronym
EPCORE DLBCL-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell Lymphoma
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Condition category
Condition code
Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional(has expanded access)
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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.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is calculated as the time from first dose to death date or last date known to be alive.
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Timepoint [1]
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throughout the study and up to 5 years following the last patient first dose
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Secondary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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0
throughout the study and up to 5 years following the last patient first dose
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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ORR is calculated as the proportion of subjects achieving a complete response or partial response. Response is determined by the Lugano criteria and LYRIC.
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Timepoint [2]
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0
throughout the study and up to 5 years following the last patient first dose
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Secondary outcome [3]
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Complete Response (CR)
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Assessment method [3]
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CR rate is calculated as the proportion of subjects achieving a complete response. Response is determined by the Lugano criteria and LYRIC.
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Timepoint [3]
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0
throughout the study and up to 5 years following the last patient first dose
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Secondary outcome [4]
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Duration of Response (DOR)
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Assessment method [4]
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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.
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Timepoint [4]
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0
throughout the study and up to 5 years following the last patient first dose
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Secondary outcome [5]
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Time to Response (TTR)
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Assessment method [5]
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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.
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Timepoint [5]
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0
throughout the study and up to 5 years following the last patient first dose
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Secondary outcome [6]
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Rate and duration of minimal residual disease (MRD) negative status
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Assessment method [6]
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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
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Timepoint [6]
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up to 5 years after randomization of the last patient
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Secondary outcome [7]
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Time to next anti-lymphoma therapy (TTNT)
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Assessment method [7]
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TTNT is calculated as the time from randomization to date of initiation of new anti-lymphoma therapy.
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Timepoint [7]
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throughout the study and up to 5 years following the last patient first dose
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Secondary outcome [8]
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Incidence and severity of adverse events (AEs)
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Assessment method [8]
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identify patterns of incidence in adverse events, with particular emphasis on pre-defined adverse events of special interest
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Timepoint [8]
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throughout the study and up to 5 years following the last patient first dose
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Secondary outcome [9]
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Incidence and severity of changes in laboratory values
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Assessment method [9]
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Clinical laboratory parameters assessed: hematology, chemistry, coagulation, tumor lysis, immunoglobulins, and urinalyses
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Timepoint [9]
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0
throughout the study and up to 5 years following the last patient first dose
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Secondary outcome [10]
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Incidence of dose interruptions and delays
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Assessment method [10]
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calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall
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Timepoint [10]
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throughout the study and up to 5 years following the last patient first dose
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Secondary outcome [11]
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Anti-epcoritamab antibody response
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Assessment method [11]
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calculate incidence of antibody response to epcoritamab in relation to dosing
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Timepoint [11]
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throughout the study and up to 5 years following the last patient first dose
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Secondary outcome [12]
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Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
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Assessment method [12]
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monitor change from baseline in health-related quality of life over time and in relation to treatment
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Timepoint [12]
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throughout the study and up to 5 years following the last patient first dose
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/01/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2028
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Actual
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Sample size
Target
552
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [2]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [3]
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Peninsula Private Hospital Clinical Trials Unit - Frankston
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Recruitment hospital [4]
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Icon Cancer Centre Corporate Office - South Brisbane
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Recruitment hospital [5]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [6]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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- Bedford Park
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Recruitment postcode(s) [2]
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- Concord
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Recruitment postcode(s) [3]
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- Frankston
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Recruitment postcode(s) [4]
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- South Brisbane
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Recruitment postcode(s) [5]
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- Waratah
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Recruitment postcode(s) [6]
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- Westmead
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Indiana
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United States of America
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Michigan
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0
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
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Antwerp
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Belgium
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Brugge
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Belgium
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Brussels
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Belgium
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State/province [11]
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Gent
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Belgium
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State/province [12]
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Jette
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Belgium
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La Louvière
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Belgium
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Leuven
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Belgium
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Sint-Niklaas
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Belgium
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Turnhout
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Canada
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Québec City
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China
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Baoding
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China
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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
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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
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Tianjin
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China
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Wuhan
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China
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Yantai
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China
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Zhengzhou
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China
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Zhenjiang
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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
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France
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Bayonne
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France
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Brest
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France
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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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France
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Lyon
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France
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Marseille
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France
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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
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France
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Quimper
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France
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Rouen
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France
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Tours
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Germany
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Cologne
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Germany
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Essen
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Germany
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Kiel
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Germany
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Würzburg
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Eger
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Hungary
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Gyor
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Hungary
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Nyiregyhaza
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Hungary
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Pécs
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Hungary
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Szeged
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Hungary
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Szekesfehervar
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Tel Aviv
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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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Ravenna
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Italy
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Rome
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Italy
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San Giovanni Rotondo
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Italy
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Trieste
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Italy
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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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Japan
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Fukuyama
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Japan
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Hokkaido
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Japan
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Kashiwa
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Japan
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Kyoto
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Matsuyama
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Japan
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Mie
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Japan
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Nagoya
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Japan
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Okayama
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Japan
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Sendai
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Japan
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Tokyo
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Japan
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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
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Busan
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Daegu
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Geumam
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Seoul
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Country [108]
0
0
Korea, Republic of
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State/province [108]
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Ulsan
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Netherlands
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State/province [109]
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Arnhem
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Country [110]
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Netherlands
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State/province [110]
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Breda
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Country [111]
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Netherlands
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State/province [111]
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Dordrecht
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0
Netherlands
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State/province [112]
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Goes
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Netherlands
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Roosendaal
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Netherlands
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State/province [114]
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Rotterdam
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Country [115]
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Norway
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State/province [115]
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Oslo
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Norway
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State/province [116]
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Trondheim
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Poland
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Katowice
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Country [118]
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Poland
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State/province [118]
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Kraków
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Poland
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Skorzewo
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Country [120]
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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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Country [125]
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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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Country [127]
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Singapore
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State/province [127]
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Kent Ridge
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Country [128]
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Singapore
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Singapore
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Country [129]
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Spain
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State/province [129]
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Badalona
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Spain
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Barcelona
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Spain
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State/province [131]
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Cadiz
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Spain
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State/province [132]
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Cáceres,
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Country [133]
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Spain
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State/province [133]
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Cáceres
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Country [134]
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Spain
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Córdoba
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Spain
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Lleida
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Country [136]
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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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Country [139]
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Spain
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Sevilla
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Country [140]
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Sweden
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Stockholm
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Country [141]
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Taiwan
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State/province [141]
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Kaohsiung
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Taiwan
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Tainan
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Country [143]
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Taiwan
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Taipei
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Country [144]
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Turkey
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Ankara
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Turkey
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Istanbul
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Country [146]
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Turkey
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Izmir
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Turkey
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Tekirdag
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Country [148]
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Turkey
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Trabzon
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Country [149]
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United Kingdom
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State/province [149]
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Birmingham
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Country [150]
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United Kingdom
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London
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Country [151]
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United Kingdom
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Norwich
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Country [152]
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United Kingdom
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State/province [152]
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Nottingham
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Country [153]
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United Kingdom
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State/province [153]
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Plymouth
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Country [154]
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United Kingdom
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State/province [154]
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Southampton
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United Kingdom
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Sutton
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Country [156]
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United Kingdom
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Genmab
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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AbbVie
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this trial is to find out if epcoritamab, also known as EPKINLY™ and GEN3013, is safe and works well as treatment for patients with diffuse large B-cell lymphoma (DLBCL) that are not responding to treatment, have grown in size, or have come back following treatment with at least 1 prior systemic cancer therapy. All participants in this trial will be randomly assigned to receive either epcoritamab or a pre-specified investigator's choice (standard of care) chemotherapy (either rituximab + gemcitabine + oxaliplatin \[R-GemOx\], or bendamustine + rituximab \[BR\]). Participants must have failed or be ineligible to receive an autologous stem cell transplant (ASCT). Epcoritamab will be injected under the skin. Investigator's choice chemotherapy will be given intravenously. Trial details include: * The trial duration will be up to 5 years. * All trial participants have a 21-day screening period, a treatment period, and a follow-up period that continues until death. * The estimated trial duration for an individual subject depends upon the treatment arm assigned: * Participants who receive epcoritamab will have 28-day treatment cycles. Epcoritamab will be given once weekly for the first 3 months, then every other week for 6 months, then every 28 days until lymphoma progression or unacceptable adverse events. * Participants who receive investigator's choice (standard of care) chemotherapy will receive treatments either: * R-GemOx: On Day 1 (or Day 1 \& Day 2), and Day 15 (or Day 15 \& Day 16) every 28 days, for up to 4 months; or * BR: On Day 1 and Day 2 every 3 weeks for up to 4.5 months.
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Trial website
https://clinicaltrials.gov/study/NCT04628494
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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