NCT05578976|Active Not RecruitingPhase 3DMCFDA Drug

A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

EPCORE DLBCL-2

A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

Genmab ClinicalTrials.gov

Compare

2 other identifiers

M20-6212023-505277-32

Study Type

interventional

Target

900

Locations

30 countries

Sites

323

Timeline

RegisteredOct 2022

StartedFeb 2023

CompletionDec 2029

Brief Summary

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally. In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

900

participants targeted

Target at P75+ for phase_3

Timeline

43mo left

Started Feb 2023

Longer than P75 for phase_3

Geographic Reach

30 countries

323 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.8 years study duration

Study Progress48%

Feb 2023Dec 2029

First Submitted

Initial submission to the registry

October 12, 2022

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed

4 months until next milestone

Study Start

First participant enrolled

February 8, 2023

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected

2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

4.3 years

First QC Date

October 12, 2022

Last Update Submit

January 22, 2025

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

Relapsed or Refractory Diffuse Large B-Cell LymphomaNon-Hodgkins LymphomaCancerEpcoritamabABBV-GMAB-3013R-CHOPRituximabEPCORE

Outcome Measures

Primary Outcomes (1)

Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5
PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC), or death due to any cause whichever comes first.
Up to Approximately 46 Months

Secondary Outcomes (5)

Number of Participants with PFS
Up to Approximately 46 Months
Number of Participants with Event-free survival (EFS)
Up to Approximately 46 Months
Percentage of Participants with Complete Remission (CR)
On or After to Approximately 28 Weeks
Overall survival (OS)
Up to Approximately 76 Months
Percentage of Participants with Minimal Residual Disease (MRD) Negativity
Up to Approximately 46 Months

Study Arms (2)

Epcoritamab and R-CHOP

EXPERIMENTAL

Participants will receive subcutaneous epcoritamab combined with intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.

Drug: EpcoritamabDrug: CyclophosphamideDrug: RituximabDrug: VincristineDrug: DoxorubicinDrug: Prednisone

R-CHOP and Rituximab

EXPERIMENTAL

Participants will receive intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by intravenous rituximab in 21-day cycles.

Drug: CyclophosphamideDrug: RituximabDrug: VincristineDrug: DoxorubicinDrug: Prednisone

Interventions

EpcoritamabDRUG

Subcutaneous Injection (SC)

Also known as: ABBV-GMAB-3013

Epcoritamab and R-CHOP

CyclophosphamideDRUG

Intravenous (IV) Injection