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A Phase 3 Trial of Epcoritamab in R/R DLBCL

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ClinicalTrials.gov Identifier: NCT04628494
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Genmab

Brief Summary:
This is an open-label, randomized (1:1), multi-center trial of epcoritamab (GEN3013; DuoBody®-CD3xCD20) versus prespecified investigator's choice of chemotherapy in patients with relapsed, refractory diffuse large B-Cell Lymphoma

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

Detailed Description:

The purpose of this 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 HDT-ASCT.

Eligible patients will be randomized (1:1) to either epcoritamab or investigator's choice of chemotherapy: R-GemOx (rituximab, gemcitabine and oxaliplatin) or BR (bendamustine and rituximab).

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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
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : May 2024


Arm Intervention/treatment
Experimental: Epcoritamab (GEN3013; DuoBody®CD3xCD20)
Epcoritamab will be administered in Cycles of 28 days until disease progression
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. BR will be administrated in Cycles of 21 days.
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




Primary Outcome Measures :
  1. Compare the clinical efficacy of epcoritamab to standard of care (SOC) - 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. Compare other measures of epcoritamab efficacy to SOC - 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. Compare other measures of epcoritamab efficacy to SOC - 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. Compare other measures of epcoritamab efficacy to SOC - 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. Compare other measures of epcoritamab efficacy to SOC - 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. Compare other measures of epcoritamab efficacy to SOC - 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. Compare other measures of epcoritamab efficacy to SOC - 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.



Information from the National Library of Medicine

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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
  2. Histologically confirmed CD20+ DLBCL including:

    1. De novo or histologically transformed (including Richter's transformation)
    2. "double-hit" or "triple-hit" (technically classified in WHO 2016 as high-grade B-cell lymphoma (HGBCL, with MYC and BCL2 and/or BCL6 translocations)
    3. Follicular lymphoma Grade 3B
  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

Main Exclusion Criteria:

  1. Primary CNS tumor or known CNS involvement
  2. Any prior therapy with a bispecific antibody targeting CD3 and CD20
  3. Radiation therapy, or major surgery within 4 weeks prior to randomization
  4. Chemotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
  5. Non-investigational antineoplastic agents or 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 30 days prior randomization
  8. Seizure disorder requiring anti-epileptic therapy
  9. Clinically significant cardiac disease,

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
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Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT04628494    
Other Study ID Numbers: GCT3013-05
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
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
Richters transformation
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