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Efficacy and Safety of Epcoritamab Monotherapy and in Combination With Lenalidomide as First-line Therapy for Anthracycline-ineligible Diffuse Large B-Cell Lymphoma Patients, an Open-label, Randomized, Multicenter, Global Phase 2 Trial (EPCORE TM DLBCL-3)

Efficacy and Safety Trial of Epcoritamab With or Without Lenalidomide as First Line Therapy for Subjects With Diffuse Large B-cell Lymphoma (EPCORE TM DLBCL-3)

jRCT Inquiry - IQVIA Contact Person

IQVIAServices Japan G.K.

Keikyu Dai-ichi Building, 4-10-18 Takanawa, Minat o-ku, Tokyo 108-0074, Japan

GCT3013-06_jRCT@iqvia.com

jRCT Inquiry - IQVIA Contact Person

IQVIA Services Japan G.K.

Keikyu Dai-ichi Building, 4-10-18 Takanawa, Minat o-ku, Tokyo 108-0074, Japan

+81-3-6859-9500

GCT3013-06_jRCT@iqvia.com

Not Recruiting

Oct. 13, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- Must have newly diagnosed CD20+ large cell lymphoma.
- Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to:
- Being age >= 80 years; AND/OR
- Being age >= 75 years and having important comorbid condition(s), which are likely to have a negati
ve impact on tolerability of anthracycline-based therapy/cytotoxic chemotherapy.
- Have Immune Effector Cell-Associated Encephalopathy (ICE) score of at least 8 out of 10.
- Have Ann Arbor Stage II-IV disease.
- Have ECOG PS of 0, 1, or 2; (ECOG PS of 3 may be considered if impairment is attributed to current lymphoma/DLBCL and if pre-phase treatment during the screening phase results in an improvement of ECOG PS to <= 2 prior to enrollment).
- Have measurable disease as per Lugano criteria.
- Have acceptable organ function based on baseline bloodwork.
- Must have fresh (preferred) or archival biopsy material at screening.

Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection.
- Has severe cardiovascular disease (other than those eligibility criteria that preclude the subject from receiving anthracycline-based therapy/cytotoxic chemotherapy),
- Has been exposed to/received any of the following prior therapies, treatments, or procedures within the specified timeframes:
- Major surgery within 4 weeks prior to the first dose of epcoritamab;
- Non-investigational antineoplastic agents (exceptanti-CD20 monoclonal antibodies) or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab;
- Autologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation;
- Live, attenuated vaccines within 30 days prior to initiation of epcoritamab;
- Investigational vaccines within 28 days before the planned first dose of epcoritamab (ie, experimental and/or non-authorized SARS-CoV-2 vaccinations and therapies are not allowed);
- Invasive investigational medical device use within 28 days before the planned first dose of epcoritamab.
- Has primary central nervous system (CNS) tumor or known CNS involvement or intracranial involvement as confirmed by mandatory brain magnetic resonance imaging/computed tomography (MRI/CT) scan at screening and, if clinically indicated, by lumb
ar puncture.
- Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form.
- Has known past or current malignancy other than inclusion diagnosis, with exceptions as stated in protocol.
- Has known or suspected allergies, hypersensitivity, or intolerance to either of the trial treatments or has known or suspected contraindication to the use of all locally available anti-cytokine therapies per local guidelines for management of cytokine release syndrome (CRS).
- Has active hepatitis B virus (HBV) (DNA polymerase chain reaction [PCR]- positive) or hepatitis C virus (HCV) (RNA PCR-positive) infection, current alcohol abuse, or cirrhosis.
- Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment.
- Has suspected active or inadequately treated latent tuberculosis.
- Has a known history of seropositivity for HIV. Note: HIV testing is required at screening only if required per local health authorities or institutional standards.

Both

People must be newly diagnosed with DLBCL and anthracycline-ineligible.

-Biological:Epcoritamab
-Epcoritamab will be administered by subcutaneous (SC) injections in 28-day cycles for up to 12 cycles.
-Other Names:
-GEN3013
-DuoBody-CD3xCD20
- EPKINLY
-Drug:Lenalidomide
-Lenalidomide will be administered orally (capsules;starting dose of 10 or 20 mg) once daily on Day 1 to Day 21 of each 28-day cycle for up to 12 cycles.
-Other Names:
-Revlimid

-Complete Response (CR) rate [Time Frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years]
-Percentage of participants achieving CR. Assessed by the Investigator per Lugano criteria

+81-23-628-5840

July. 25, 2025

No

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