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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04628494




Registration number
NCT04628494
Ethics application status
Date submitted
9/11/2020
Date registered
13/11/2020
Date last updated
7/06/2024

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
Other interventions - 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


Other interventions: 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
Other interventions
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
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Indiana
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Kaohsiung
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Taipei
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Turkey
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Ankara
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Istanbul
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Izmir
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Tekirdag
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Birmingham
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Plymouth
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Sutton
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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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04628494
Trial related presentations / publications
Public notes

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