Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
NCT ID: NCT04663347
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
543 participants
INTERVENTIONAL
2020-11-03
2027-09-30
Brief Summary
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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.
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Detailed Description
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All participants in the trial will receive epcoritamab, as monotherapy or in combination. The following regimens will be investigated:
* Arm 1: epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in participants with previously untreated diffuse large B-cell lymphoma (DLBCL)
* Arm 2: epcoritamab + rituximab and lenalidomide (R2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL)
* Arm 3: epcoritamab + rituximab and bendamustine (BR) in participants with previously untreated FL
* Arm 4: epcoritamab + rituximab, cytarabine, dexamethasone, and oxaliplatin/ carboplatin (R-DHAX/C) in participants with R/R DLBCL eligible for autologous stem cell transplant (ASCT)
* Arm 5: epcoritamab + gemcitabine and oxaliplatin (GemOx) in participants with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity
* Arm 6: epcoritamab + R2 in participants with previously untreated FL
* Arm 7: epcoritamab maintenance in participants with FL who achieve a complete response (CR) or a partial response (PR) following first or second line SOC treatment
* Arm 8: epcoritamab + reduced dose of R-CHOP (R mini-CHOP) in participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline
* Arm 9: epcoritamab + lenalidomide for second-line treatment in participants with R/R FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy
* Arm 10: epcoritamab + rituximab, ifosfamide, carboplatin, and etoposide phosphate (R-ICE) in participants with R/R DLBCL eligible for ASCT
The trial consists of two parts: Part 1 ('Dose Escalation') and Part 2 ('Dose Expansion'). The primary objective of Part 1 is safety, and it includes Arm 1-5 and Arm 10. Part 2 includes all 10 arms (Arm 1-10) and the primary goal of all arms, except Arm 7, is preliminary efficacy. For Arm 7, the primary goal is safety. Participants in Arm 1-5 and Arm 10 can only participate in either Part 1 or Part 2. Dose Limiting Toxicities (DLTs) will be assessed in Part 1 and for a selected number of participants in Arm 8 during a 28-day period (safety run-in). The arms are conducted in parallel.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 - Epcoritamab + R-CHOP
In participants with previously untreated DLBCL.
rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
6 cycles (21-day cycles)
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.
Arm 2 - Epcoritamab + R2
In participants with R/R FL.
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.
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.
Arm 3 - Epcoritamab + BR
In participants with previously untreated FL.
rituximab and bendamustine
6 cycles (28-day cycles)
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.
Arm 4 - Epcoritamab + R-DHAX/C
In participants with R/R DLBCL eligible for ASCT.
rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
3 cycles (21-day cycles)
Epcoritamab
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
Arm 5 - Epcoritamab + GemOx
In participants with R/R DLBCL ineligible ASCT.
gemcitabine and oxaliplatin
4 cycles (28-day cycles)
Epcoritamab
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
Arm 6 - Epcoritamab + R2
In participants with previously untreated FL.
rituximab and lenalidomide
rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles)
Epcoritamab
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Arm 7 - Epcoritamab maintenance
In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L.
Epcoritamab
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Arm 8 - Epcoritamab + R mini-CHOP
In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline.
rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
6 cycles (21-day cycles)
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.
Arm 9 - Epcoritamab + Lenalidomide
In participants with R/R FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy.
Lenalidomide
12 cycles (28-day cycles)
Epcoritamab
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Arm 10 - Epcoritamab + R-ICE
In participants with R/R DLBCL eligible for ASCT.
rituximab, ifosfamide, carboplatin, and etoposide phosphate
3 cycles (21-day cycles)
Epcoritamab
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
Interventions
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rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
6 cycles (21-day cycles)
rituximab and lenalidomide
rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles)
rituximab and bendamustine
6 cycles (28-day cycles)
rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
3 cycles (21-day cycles)
gemcitabine and oxaliplatin
4 cycles (28-day cycles)
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.
rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
6 cycles (21-day cycles)
Lenalidomide
12 cycles (28-day cycles)
rituximab, ifosfamide, carboplatin, and etoposide phosphate
3 cycles (21-day cycles)
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.
Epcoritamab
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Epcoritamab
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
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.
Epcoritamab
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Epcoritamab
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
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.
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.
Epcoritamab
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Genmab
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Falchi L, Sureda A, Leppa S, Vermaat JSP, Nijland M, Christensen JH, de Vos S, Holte H, Merryman RW, Lugtenburg PJ, Abrisqueta P, Linton KM, Sunkersett G, Hoehn D, Rana A, Abbas A, Marek J, Hao Y, Steele AJ, Morehouse C, Hutchings M, Belada D. Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma. Blood. 2025 Nov 27;146(22):2629-2640. doi: 10.1182/blood.2025029909.
Brody JD, Jorgensen J, Belada D, Costello R, Trneny M, Vitolo U, Lewis DJ, Karimi YH, Sureda A, Andre M, Wahlin BE, Lugtenburg PJ, Jiang T, Karagoz K, Steele AJ, Abbas A, Wang L, Risum M, Cordoba R. Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial. Blood. 2025 Apr 10;145(15):1621-1631. doi: 10.1182/blood.2024026830.
Related Links
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Patient website: Recruiting clinical sites in Finland
Other Identifiers
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2023-504805-35-00
Identifier Type: CTIS
Identifier Source: secondary_id
2020-000845-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NL74222.056.20
Identifier Type: REGISTRY
Identifier Source: secondary_id
283235
Identifier Type: OTHER
Identifier Source: secondary_id
RECF4377
Identifier Type: OTHER
Identifier Source: secondary_id
GCT3013-02
Identifier Type: -
Identifier Source: org_study_id
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