Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Eligible patients will receive epcoritamab (28-day cycle) that will be administered as subcutaneous (SC) injections until disease progression, or one or more of the treatment discontinuation criteria are met.

Epcoritamab

The purpose of this program is to provide investigational epcoritamab, an antibody also known as GEN3013 (DuoBody-CD3xCD20), in an expanded access setting for eligible patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) who have a high unmet medical need with no other treatment options. It is a requirement that patients do not qualify for an ongoing epcoritamab clinical program or are unable to participate due to logistical reasons.

Access to investigational epcoritamab can be requested by contacting preapprovalaccessprograms@genmab.com.

This is a multicenter program conducted within the United States. The program will consist of screening, treatment (Cycle 1 Day 1 until epcoritamab discontinuation), safety follow-up, post-treatment and/or survival follow-up.

Expanded Access Program for Epcoritamab

Expanded Access Program (EAP) to Provide Epcoritamab (GEN3013) to Eligible Patients With Relapsed or Refractory Large B-cell Lymphoma

AbbVie

Genmab

T-cell/histiocyte Rich Large B Cell Lymphoma

Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met

R-GemOx will be administrated in Cycles of 28 days until maximum cycles completion or any of the discontinuation criteria is met

BR will be administrated in Cycles of 21 days until maximum cycles completion or any of the discontinuation criteria is met

Following mandatory pre-medication subject will be administered epcoritamab as a subcutaneous injection.

Following mandatory pre-medication subject will be administered intravenously either BR or R-GemOx.

Investigator's Choice Chemotherapy

The drug that will be investigated in the study is an antibody, epcoritamab, also known as EPKINLY™ and GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator's choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT

The trial is an open label, multi-center, global phase 3 randomized trial of epcoritamab, GEN3013. The goal of this randomized trial is to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy, in patients with relapsed, refractory diffuse large B-Cell Lymphoma who have failed or are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). No change in chemotherapy is permitted for participants during the treatment phase of the trial.

A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

OS is calculated as the time from first dose to death date or last date known to be alive.

PFS is calculated as the time from randomization to the date of disease progression or death, whichever is earlier. Progression is determined by the Lugano criteria and LYRIC.

ORR is calculated as the proportion of subjects achieving a complete response or partial response. Response is determined by the Lugano criteria and LYRIC.

CR rate is calculated as the proportion of subjects achieving a complete response. Response is determined by the Lugano criteria and LYRIC.

DOR is calculated as the time from initial response (CR or PR) to date of progression or death, whichever is earlier. Response and progression are determined by the Lugano criteria and LYRIC.

TTR is calculated as the time from randomization to date of initial response (CR or PR) among responders only. Response is determined by the Lugano criteria and LYRIC.

Compare other measures of efficacy to SOC - MRD negativity rate, defined as the proportion of subjects who have at least one negative MRD sample at any time point prior to start of subsequent anti-lymphoma therapy

TTNT is calculated as the time from randomization to date of initiation of new anti-lymphoma therapy.

identify patterns of incidence in adverse events, with particular emphasis on pre-defined adverse events of special interest

Clinical laboratory parameters assessed: hematology, chemistry, coagulation, tumor lysis, immunoglobulins, and urinalyses

calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall

calculate incidence of antibody response to epcoritamab in relation to dosing

monitor change from baseline in health-related quality of life over time and in relation to treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Expanded Access Program for Epcoritamab	NCT05733650	Large B-cell Ly... Diffuse Large B... Primary Mediast... High Grade B-ce... Grade 3B Follic...	Epcoritamab	18 Years -	Genmab
Expanded Access Program for Epcoritamab	NCT05733650	Large B-cell Ly... Diffuse Large B... Primary Mediast... High Grade B-ce... Grade 3B Follic...	Epcoritamab	18 Years -	Genmab
A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL	NCT04628494	Diffuse Large B...	Epcoritamab Investigator's ...	18 Years -	Genmab

Spots Global Cancer Trial Database for follicular grade 3b