Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma

NCT05660967 | Active Not Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: GCT3013-062021-005744-29jRCT202123001510062192023-504832-16-00
• Study Type: interventional
• Target: 111
• Locations: 12 countries
• Sites: 74

Brief Summary

The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as EPKINLY™, GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

Double-hit lymphoma; Triple-hit lymphoma; Follicular grade 3B; T-cell/histiocyte rich LBCL; DuoBody®; Anti-CD3; Anti-CD20; Subcutaneous; Bispecific antibody; EPCORE

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) rate

  Percentage of participants achieving CR. Assessed by the Investigator per Lugano criteria

  From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years

Secondary Outcomes (16)

• Duration of response (DOR)

  From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years

• Duration of complete response (DOCR)

  From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years

• Time to response (TTR)

  From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 1 year

• Overall Response Rate (ORR)

  From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years

• Progression-free survival (PFS)

  From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years

Study Arms (2)

Epcoritamab monotherapy

EXPERIMENTAL

Biological: Epcoritamab

Epcoritamab in combination with lenalidomide

EXPERIMENTAL

Biological: Epcoritamab; Drug: Lenalidomide

Interventions

Epcoritamab BIOLOGICAL

Epcoritamab will be administered by subcutaneous (SC) injections in 28-day cycles for up to 12 cycles.

Also known as: GEN3013, DuoBody®-CD3×CD20, EPKINLY™

Epcoritamab in combination with lenalidomide; Epcoritamab monotherapy

Lenalidomide DRUG

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.

Also known as: Revlimid®

Epcoritamab in combination with lenalidomide

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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 (except anti-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 lumbar puncture.
• Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form.
• 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.

Sponsors & Collaborators

• Genmab: lead
• AbbVie: collaborator

Study Sites (74)

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

Kepler Universitätsklinikum

Linz, Austria

Location

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, Austria

Location

Klinikum Wels-Grieskirchen GmbH

Wels, Austria

Location

Institut Jules Bordet

Anderlecht, Belgium

Location

ZNA

Antwerp, Belgium

Location

UZ Brussels

Jette, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

AZ Delta

Roeselare, Belgium

Location

Vitaz

Temse, Belgium

Location

AZ Turnhout - Campus Sint-Elisabeth

Turnhout, Belgium

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Location

Fakultni nemocnice v Motole

Prague, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Location

CHU Angers - Hôpital Hôtel Dieu

Angers, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Hopital Claude Huriez - CHRU Lille

Lille, France

Location

Hopital de la Conception - APHM

Marseille, France

Location

CHU de Nantes - Hotel Dieu

Nantes, France

Location

Hôpital Saint-Antoine

Paris, France

Location

Hôpital Saint-Louis

Paris, France

Location

CHU de Bordeaux - Hôpital Haut-Lévêque

Pessac, France

Location

CHU Amiens - Hopital Sud

Salouël, France

Location

CHU Tours - Hôpital Bretonneau

Tours, France

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Location

Universitaetsklinikum Aachen AOeR

Aachen, Germany

Location

Vivantes Klinikum Neukoelln

Berlin, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Location

Clinica di Ematologia AOU Ospedali Riuniti di Ancona

Ancona, Italy

Location

IRCCS Centro di Riferimento Oncologico

Aviano, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

Bologna, Italy

Location

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

Brescia, Italy

Location

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Italy

Location

IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST

Meldola, Italy

Location

IEO Istituto Europeo di Oncologia Parent

Milan, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Azienda Ospedaliera Vincenzo Cervello

Palermo, Italy

Location

AUSL Piacenza Ospedale Guglielmo da Saliceto

Piacenza, Italy

Location

Azienda sanitaria integrata università di Trieste

Trieste, Italy

Location

Kyushu University Hospital

Fukuoka, Japan

Location

Kagoshima University Hospital

Kagoshima, Japan

Location

Kanazawa University Hospital

Kanazawa, Japan

Location

National Cancer Center Hospital East

Kashiwa, Japan

Location

Cancer Institute Hospital of JFCR

Kōtoku, Japan

Location

Matsuyama Red Cross Hospital

Matsuyama, Japan

Location

NHO Nagoya Medical Center

Nagoya, Japan

Location

Kindai University Hospital

Ōsaka-sayama, Japan

Location

Yamagata University Hospital

Yamagata, Japan

Location

Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

Biała Podlaska, Poland

Location

Pratia MCM Krakow

Krakow, Poland

Location

Centrum Medyczne Pratia Poznan

Skorzewo, Poland

Location

MICS Centrum Medyczne Torun

Torun, Poland

Location

Keimyung University Dongsan Hospital

Daegu, South Korea

Location

National Cancer Center

Goyang-si, South Korea

Location

Jeonbuk National University Hospital

Jeonju, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

ICO Badalona - Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Spain

Location

Hospital Universitario Nuestra Señora de Valme

Seville, Spain

Location

Hospital Universitario Puerta del Mar

Seville, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Royal Marsden Hospital - Fulham

London, United Kingdom

Location

Derriford Hospital

Plymouth, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

Royal Marsden Hospital

Sutton, United Kingdom

Location

Royal Cornwall Hospital NHS Trust

Truro, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 21, 2022
• Study Start: March 6, 2023
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): June 28, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5); DE (4); CZ (3); FR (10); US (1); BE (7); IT (11); KR (6); AU (3); PL (4); ES (11); JP (9)