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NCT04663347

PHASE1/PHASE2

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

Sponsor: Genmab

View on ClinicalTrials.gov

Summary

The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating participants with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to identify the most appropriate dose of epcoritamab, and the aim of the second part of the trial is to assess the selected epcoritamab dose in a larger group of participants with B-NHL. All participants in this trial will receive either epcoritamab alone, or epcoritamab combined with another standard treatment regimen, with a total of 10 different treatment arms being studied. Trial details include: * The treatment duration for each participant depends upon which arm of treatment they are assigned to. * The visit frequency for each participant depends upon which arm of treatment they are assigned to, but will be weekly to start for all participants, then will decrease to either: every 2 weeks, or every 3 weeks, or every 4 weeks, or every 8 weeks. * All participants will receive active drug; no one will be given placebo. Participants who receive treatment with epcoritamab will have it injected right under the skin. Participants will receive a different regimen of epcoritamab depending upon which arm of treatment they are assigned. Participants who receive standard treatments will have intravenous (IV) infusions and/or oral administration of those treatments. Participants will receive a different standard treatment regimen depending upon which arm of treatment they are assigned.

Official title: A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

543

Start Date

2020-11-03

Completion Date

2027-09-30

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Diffuse Large B-Cell Lymphoma Follicular Lymphoma

Interventions

DRUG

rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone

6 cycles (21-day cycles)

DRUG

rituximab and lenalidomide

rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles)

DRUG

rituximab and bendamustine

6 cycles (28-day cycles)

DRUG

rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin

3 cycles (21-day cycles)

DRUG

gemcitabine and oxaliplatin

4 cycles (28-day cycles)

BIOLOGICAL

Epcoritamab

Every week in cycle 1-4, every 3 weeks in cycle 5 and 6, followed by every 4 weeks in cycle 7 for a total of 1 year.

DRUG

rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone

6 cycles (21-day cycles)

DRUG

Lenalidomide

12 cycles (28-day cycles)

DRUG

rituximab, ifosfamide, carboplatin, and etoposide phosphate

3 cycles (21-day cycles)

BIOLOGICAL

Epcoritamab

Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.

BIOLOGICAL

Epcoritamab

Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.

BIOLOGICAL

Epcoritamab

Every week in cycle 1 and then every 8 weeks for a total of 2 years.

BIOLOGICAL

Epcoritamab

Every week in cycles 1 and 2, then every 3 weeks in cycles 3 to 6 and then every 4 weeks for cycles 7 and 8.

BIOLOGICAL

Epcoritamab

Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.

BIOLOGICAL

Epcoritamab

Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.

BIOLOGICAL

Epcoritamab

Eligible participants will receive subcutaneous (SC) epcoritamab in 28-day cycles. Fixed-treatment epcoritamab will be administered following a 2-Set Up Dosing regimen in Cycle 1. There will be 2 cohorts, 2a and 2b with different dosing schedules. Cohort 2a will be dosed weekly (QW) in Cycles 1-3, once every 2 weeks (Q2W) in Cycles 4-9, and once every 4 weeks (Q4W) in Cycle 10 and beyond for up to 2 years. In cohort 2b, an alternate dosing schedule for epcoritamab will be explored: epcoritamab administered QW for Cycles 1-2 only, then Q4W in Cycle 3 and beyond for up to 2 years.

DRUG

Rituximab and Lenalidomide

Rituximab 375 milligrams per meter squared (mg/m\^2) will be administered intravenously QW in Cycle 1 and Q4W in Cycles 2-5. Lenalidomide 20 mg will be administered orally daily for 21 days for 12 cycles.

BIOLOGICAL

Epcoritamab

Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.

Key Inclusion Criteria 1. Measurable disease defined as ≥1 measurable nodal lesion (long axis \>1.5 cm and short axis \>1.0 cm) or ≥1 measurable extra-nodal lesion (long axis \>1.0 cm) on computed tomography (CT) or magnetic resonance imaging (MRI). Applies to all arms except arm 7. 2. Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2 3. Acceptable organ function at screening 4. CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy 5. If of childbearing potential participant must practicing a highly effective method of birth control 6. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control Arm 1: * Newly diagnosed DLBCL * DLBCL, not otherwise specified (NOS) * "Double-hit" or "triple-hit" DLBCL * FL Grade 3B Arm 2: R/R FL Arm 3: Newly diagnosed, previously untreated FL grade 1-3A Arm 4: * Documented R/R DLBCL and eligible for HDT-ASCT * DLBCL, NOS * "Double-hit" or "triple-hit" DLBCL * FL Grade 3B Arm 5: * Documented R/R DLBCL and ineligible for HDT-ASCT * DLBCL, NOS * "Double-hit" or "triple-hit" DLBCL * FL Grade 3B Arm 6: Newly diagnosed, previously untreated FL grade 1-3A Arm 7: * FL Grade 1-3A * If PR or CR per Lugano criteria following first-line or second-line treatment with SOC regimen, and last dose of SOC within 6 months prior to enrollment. Arm 8: * Newly diagnosed DLBCL who are not fit to receive full-dose anthracycline * T-cell/histiocyte rich DLBCL * "Double-hit" or "triple-hit" DLBCL * FL Grade 3B Arm 9: * R/R FL * Progressed within 24 months of initiating first-line treatment Arm 10: * Documented R/R DLBCL and eligible for HDT-ASCT * DLBCL, NOS * "Double-hit" or "triple-hit" DLBCL * FL Grade 3B Key Exclusion Criteria 1. Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab 2. Any prior treatment with a bispecific antibody targeting CD3 and CD20. 3. Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab 4. Clinically significant cardiovascular disease 5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results 6. CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture 7. Positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection 8. Known history of seropositivity of human immunodeficiency virus (HIV) 9. Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months 10. Neuropathy \> grade 1 11. Receiving immunostimulatory agent 12. Prior allogeneic HSCT 13. Current seizure disorder requiring anti-epileptic therapy NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (57)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center Michigan Medicine

Ann Arbor, Michigan, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Mount Sinai

New York, New York, United States

Memorial Sloan Kettering CC

New York, New York, United States

Levine Cancer Center

Charlotte, North Carolina, United States

Southwestern Medical Center

Dallas, Texas, United States

Austin Health

Heidelberg, Australia

Linear Clinical Research Limited

Nedlands, Australia

AZ Sint-Jan

Bruges, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

CHU UCL Namur Site Godinne

Yvoir, Belgium

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice Ostrava

Ostrava - Poruba, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

Vseobecna Fakultni Nemocnice

Prague, Czechia

Århus Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

Vejle Sygehus

Vejle, Denmark

Kuopio University Hospital

Kuopio, Finland

HUS Cancer Center

Lahti, Finland

Hopital Claude Huriez - CHRU Lille

Lille, France

Hôpital de la Timone

Marseille, France

Hôpital Saint-Louis

Paris, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

Bergamo, Italy

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

Bologna, Italy

Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS

Candiolo, Italy

IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST

Meldola, Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

Reggio Emilia, Italy

Amsterdam UMC, Locatie VUMC

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen (UMCG)

Groningen, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

UMC Utrecht

Utrecht, Netherlands

Oslo Universitetssykehus HF, Radiumhospitalet

Oslo, Norway

ICO l Hospitalet

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Södra Älvsborgs Sjukhus

Borås, Sweden

Sahlgrenska Sjukhuset

Gothenburg, Sweden

Skånes Universitetssjukhus

Lund, Sweden

Karolinska Universitetssjukhuset

Solna, Sweden

Akademiska Sjukhuset

Uppsala, Sweden

The Christie Hospital

Manchester, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

Clinical Research Directory

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (57)