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
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Condition or disease | Intervention/treatment | Phase |
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Diffuse Large B-cell Lymphoma | Biological: Epcoritamab Drug: Investigator's Choice Chemotherapy | Phase 3 |
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).
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 |
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Experimental: Epcoritamab (GEN3013; DuoBody®CD3xCD20)
Epcoritamab will be administered in Cycles of 28 days until disease progression
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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.
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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 |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
- Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy
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Histologically confirmed CD20+ DLBCL including:
- De novo or histologically transformed (including Richter's transformation)
- "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)
- Follicular lymphoma Grade 3B
- ECOG PS score of 0-2
- Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening
- Patients must have detectable disease by PET scan and measurable by CT scan or MRI
- Acceptable renal and liver function
Main Exclusion Criteria:
- Primary CNS tumor or known CNS involvement
- Any prior therapy with a bispecific antibody targeting CD3 and CD20
- Radiation therapy, or major surgery within 4 weeks prior to randomization
- Chemotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
- Non-investigational antineoplastic agents or any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
- ASCT within 100 days of randomization
- Treatment with CAR-T therapy within 30 days prior randomization
- Seizure disorder requiring anti-epileptic therapy
- Clinically significant cardiac disease,

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

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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
double-hit DLBCL triple-hit DLBCL follicular grade 3B transformed DLBCL Richters transformation |
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 |