EFFICACY AND SAFETY TRIAL OF EPCORITAMAB WITH OR WITHOUT LENALIDOMIDE AS FIRST LINE THERAPY FOR SUBJECTS WITH DIFFUSE LARGE B-CELL LYMPHOMA.

Trial details

Who runs it

Genmab A/S

Trial code

EU 2023-504832-16-00

Record updated

2026. március 30.

Original description

Evaluate the clinical efficacy of epcoritamab monotherapy or epcoritamab and lenalidomideRead full original descriptionShow less

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

Evaluate the clinical efficacy of epcoritamab monotherapy or epcoritamab and lenalidomide

Inclusion: Must have newly diagnosed CD20+ large cell lymphoma; Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to: oBeing age ≥80 years; AND/OR oBeing age ≥75 years and having important comorbid condition(s), which are likely to have a negative 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.

Exclusion: 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: oMajor surgery within 4 weeks prior to the first dose of epcoritamab; oNon-investigational antineoplastic agents or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab; oAutologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation; oLive, attenuated vaccines within 30 days prior to initiation of epcoritamab; oInvestigational 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); oInvasive investigational medical device use within 28 days before the planned first dose of epcoritamab; Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection; 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; 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 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 lumbar puncture.

EU CTIS 2023-504832-16-00