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

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ClinicalTrials.gov Identifier: NCT04628494
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : January 11, 2023
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Genmab

Study Description
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Brief Summary:
The drug that will be investigated in the study is an antibody, epcoritamab, also known as 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

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Biological: Epcoritamab Drug: Investigator's Choice Chemotherapy Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Epcoritamab (GEN3013; DuoBody®CD3xCD20)
Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met
 Biological: Epcoritamab
Following mandatory pre-medication subject will be administered epcoritamab as a subcutaneous injection.
Other Name: GEN3013; DuoBody®-CD3xCD20
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

 Drug: Investigator's Choice Chemotherapy
Following mandatory pre-medication subject will be administered intravenously either BR or R-GemOx.
Other Name: BR or R-GemOx


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: throughout the study and up to 2 years following the last patient first dose ]
    OS is calculated as the time from first dose to death date or last date known to be alive.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: throughout the study and up to 2 years following the last patient first dose ]
    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.

  2. Overall Response Rate (ORR) [ Time Frame: throughout the study and up to 2 years following the last patient first dose ]
    ORR is calculated as the proportion of subjects achieving a complete response or partial response. Response is determined by the Lugano criteria and LYRIC.

  3. Complete Response (CR) [ Time Frame: throughout the study and up to 2 years following the last patient first dose ]
    CR rate is calculated as the proportion of subjects achieving a complete response. Response is determined by the Lugano criteria and LYRIC.

  4. Duration of Response (DOR) [ Time Frame: throughout the study and up to 2 years following the last patient first dose ]
    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.

  5. Time to Response (TTR) [ Time Frame: throughout the study and up to 2 years following the last patient first dose ]
    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.

  6. Rate and duration of minimal residual disease (MRD) negative status [ Time Frame: up to 2 years after randomization of the last patient ]
    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

  7. Time to next anti-lymphoma therapy (TTNT) [ Time Frame: throughout the study and up to 2 years following the last patient first dose ]
    TTNT is calculated as the time from randomization to date of initiation of new anti-lymphoma therapy.

  8. Incidence and severity of adverse events (AEs) [ Time Frame: throughout the study and up to 2 years following the last patient first dose ]
    identify patterns of incidence in adverse events, with particular emphasis on pre-defined adverse events of special interest

  9. Incidence and severity of changes in laboratory values [ Time Frame: throughout the study and up to 2 years following the last patient first dose ]
    Clinical laboratory parameters assessed: hematology, chemistry, coagulation, tumor lysis, immunoglobulins, and urinalyses

  10. Incidence of dose interruptions and delays [ Time Frame: throughout the study and up to 2 years following the last patient first dose ]
    calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall

  11. Anti-epcoritamab antibody response [ Time Frame: throughout the study and up to 2 years following the last patient first dose ]
    calculate incidence of antibody response to epcoritamab in relation to dosing

  12. Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) [ Time Frame: throughout the study and up to 2 years following the last patient first dose ]
    monitor change from baseline in health-related quality of life over time and in relation to treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628494


Contacts
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Contact: Genmab A/S Trial Information +45 70202728 clinicaltrials@genmab.com

Locations
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Sponsors and Collaborators
Genmab
AbbVie
More Information
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Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT04628494    
Other Study ID Numbers: GCT3013-05
2020-003016-27 ( EudraCT Number )
jRCT2021220017 ( Registry Identifier: Japan Registry for Clinical Trials (jRCT) )
CTR20221558 ( Registry Identifier: Drug Clinal Trial Registration and Information Disclosure Platform (ChinaDrugTrials.org.cn) )
MOH_2021-01-18_009672 ( Registry Identifier: Clinical Research Site - mytrial )
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genmab:
double-hit DLBCL
triple-hit DLBCL
follicular grade 3B
transformed DLBCL
T-cell histiocytes-rich large B cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin