The trial is taking place at:
F

Franciscan Health | Indiana Blood and Marrow Transplantation

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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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Genmab

Status and phase

Active, not recruiting
Phase 3

Conditions

Diffuse Large B-cell Lymphoma

Treatments

Drug: Investigator's Choice Chemotherapy
Biological: Epcoritamab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04628494
MOH_2021-01-18_009672 (Registry Identifier)
2020-003016-27 (EudraCT Number)
286972 (Other Identifier)
CTR20221558 (Registry Identifier)
2023-504830-23-00 (Registry Identifier)
GCT3013-05
jRCT2021220017 (Registry Identifier)

Details and patient eligibility

About

The drug that will be investigated in the study is an antibody, epcoritamab, also known as EPKINLY™ and 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

Full 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.

Enrollment

552 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 since lymphoma diagnosis

One of the confirmed histologies below with CD20-positivity:

  • DLBCL, NOS, including de novo or histologically transformed from FL
  • "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
  • FL Grade 3B
  • T-cell/histiocyte-rich large B-cell lymphoma
  • 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
  • Life expectancy >2 months on SOC treatment

Main Exclusion Criteria:

  • Primary Central Nervous System (CNS) tumor or known CNS involvement
  • Any prior therapy with a bispecific antibody targeting CD3 and CD20
  • Major surgery within 4 weeks prior to randomization
  • Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
  • 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 100 days prior to randomization
  • Seizure disorder requiring anti-epileptic therapy
  • Clinically significant cardiac disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

552 participants in 2 patient groups

Epcoritamab (GEN3013; DuoBody®CD3xCD20)
Experimental group
Description:
Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met
Treatment:
Biological: Epcoritamab
Investigator's choice of chemotherapy
Active Comparator group
Description:
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:
Drug: Investigator's Choice Chemotherapy

Trial contacts and locations

203

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Central trial contact

Genmab A/S Trial Information

Data sourced from clinicaltrials.gov

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