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) (EPCORE DLBCL-2)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505277-32-00

Acronym

M20-621

Enrollment

435

Registered

2024-04-08

Start date

2023-01-26

Completion date

Unknown

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Brief summary

The primary endpoint is PFS defined as the duration from the date of randomization to the date of any of the following (whichever occurs first). The primary analysis population is the subset of subjects with an IPI of 3-5, Death due to any causes., Disease progression based on the independent review committee (IRC) assessment per Lugano criteria.

Detailed description

PFS in all randomized subjects., CR on or after the EOT based on the IRC assessment per Lugano criteria, where EOT is defined as treatment completion or early treatment discontinuation., OS, defined as time from randomization until death due to any causes., MRD negativity.

Interventions

DRUGTruxima 500 mg concentrate for solution for infusion

DRUGCyclophosphamide Injection 500 mg.

DRUGEpcoritamab (GEN3013)

DRUGVincristine Sulfate 1 mg/ml solution for injection

DRUGDoxorubicinhydrochlorid Bendalis 2 mg/ml Injektionslösung

DRUGTruxima 100 mg concentrate for solution for infusion

DRUGPrednisone Zentiva 5 mg compresse

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is PFS defined as the duration from the date of randomization to the date of any of the following (whichever occurs first). The primary analysis population is the subset of subjects with an IPI of 3-5, Death due to any causes., Disease progression based on the independent review committee (IRC) assessment per Lugano criteria.	—

Secondary

Measure	Time frame
PFS in all randomized subjects., CR on or after the EOT based on the IRC assessment per Lugano criteria, where EOT is defined as treatment completion or early treatment discontinuation., OS, defined as time from randomization until death due to any causes., MRD negativity.	—

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, France, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026