EPCORE™ DLBCL-3
Research type
Research Study
Full title
A RANDOMIZED, OPEN-LABEL, MULTICENTER, GLOBAL, PHASE 2 TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF EPCORITAMAB (GEN3013; DUOBODY®-CD3×CD20) AS MONOTHERAPY OR IN COMBINATION WITH LENALIDOMIDE AS FIRST-LINE THERAPY FOR ANTHRACYCLINE-INELIGIBLE SUBJECTS WITH DIFFUSE LARGE B CELL LYMPHOMA
IRAS ID
1006219
Contact name
Jens Riemann Kildsgaard
Contact email
Sponsor organisation
Genmab A/S
Eudract number
2021-005744-29
Clinicaltrials.gov Identifier
Research summary
This is an open-label, randomised, global, Phase 2 trial to evaluate the efficacy and safety of epcoritamab as monotherapy or in combination with lenalidomide as first-line therapy for anthracycline-ineligible subjects with diffuse large B-cell lymphoma (DLBCL).
This trial will employ a 2-stage trial design enrolling up to approximately 180 patients. In Stage 1, eligible patients will be randomised into 1 of 2 treatment arms: either epcoritamab monotherapy or epcoritamab plus lenalidomide (up to approximately 40 patients each). Epcoritamab will be administered as subcutaneous (SC) (under the skin) injections. Lenalidomide will be self-administered orally in the combination treatment arm. In Stage 2 approximately 60 additional patients may be enrolled at the treatment regimen selected for expansion.
The trial periods in both stages consist of screening, treatment, safety follow-up, progression-free survival follow-up, and survival follow-up. Each treatment cycle is 28 days. Patients will receive a maximum of 12 cycles (ie, up to 1 year) of treatment.
The primary objective is to evaluate the clinical efficacy of epcoritamab monotherapy or epcoritamab and lenalidomide. The primary endpoint is to achieve a complete response (CR) rate determined by Lugano criteria.
REC name
West of Scotland REC 1
REC reference
22/WS/0130
Date of REC Opinion
19 Oct 2022
REC opinion
Further Information Favourable Opinion