Diffuse Large B-Cell LymphomaPhase 1/2EPCORE™ NHL-2NCT04663347
Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
A Phase 1/2 study testing rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, rituximab and lenalidomide and rituximab and bendamustine in people with Diffuse Large B-Cell Lymphoma and Follicular Lymphoma, run by Genmab at 57 sites in 13 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
- What is being tested?
- rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, rituximab and lenalidomide and rituximab and bendamustine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 543 participants
- Where
- 57 sitesin 13 countries
- Study dates
- 3 Nov 2020to 30 Sep 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
- Acceptable organ function at screening
- CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
- If of childbearing potential participant must practicing a highly effective method of birth control
- A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
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- 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
Who cannot join
- Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
- Any prior treatment with a bispecific antibody targeting CD3 and CD20.
- Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab
- Clinically significant cardiovascular disease
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
- 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
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- Positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
- Known history of seropositivity of human immunodeficiency virus (HIV)
- Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
- Neuropathy > grade 1
- Receiving immunostimulatory agent
- Prior allogeneic HSCT
- Current seizure disorder requiring anti-epileptic therapy
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
57 sites in 13 countries.
57 sites in 13 countries
United States11 sites
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Levine Cancer Center
Charlotte, North Carolina, 28204
Southwestern Medical Center
Dallas, Texas, 75390
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Cedars-Sinai Medical Center
Los Angeles, California, 90048
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering CC
New York, New York, 10065
University of California San Francisco
San Francisco, California, 94143
Italy7 sites
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, 24127
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna
Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS
Candiolo, 10060
IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
Meldola, 47014
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, 42123
Netherlands6 sites
Amsterdam UMC, Locatie VUMC
Amsterdam, 1105 AZ
Universitair Medisch Centrum Groningen (UMCG)
Groningen, 9713
Leids Universitair Medisch Centrum
Leiden, 2333 ZA
Maastricht University Medical Center
Maastricht, 6229 HX
Erasmus Medisch Centrum
Rotterdam
UMC Utrecht
Utrecht, 3584
Spain5 sites
ICO l Hospitalet
Barcelona, 08908
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario de Salamanca
Salamanca, 37007
Sweden5 sites
Södra Älvsborgs Sjukhus
Borås
Sahlgrenska Sjukhuset
Gothenburg, 413 45
Skånes Universitetssjukhus
Lund
Karolinska Universitetssjukhuset
Solna
Akademiska Sjukhuset
Uppsala
Czechia4 sites
Fakultni nemocnice Hradec Kralove
Hradec Králové
Fakultni nemocnice Ostrava
Ostrava - Poruba
Fakultni nemocnice v Motole
Prague, 15006
Vseobecna Fakultni Nemocnice
Prague
Denmark4 sites
Århus Hospital
Aarhus
Rigshospitalet
Copenhagen, 2100
Odense University Hospital
Odense
Vejle Sygehus
Vejle
France4 sites
Hopital Claude Huriez - CHRU Lille
Lille, 59037
Hôpital de la Timone
Marseille, 13005
Hôpital Saint-Louis
Paris, 75475
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Belgium3 sites
AZ Sint-Jan
Bruges, 8000
Universitair Ziekenhuis Gent
Ghent, 9000
CHU UCL Namur Site Godinne
Yvoir, 5530
United Kingdom3 sites
The Christie Hospital
Manchester
Freeman Hospital
Newcastle upon Tyne, NE7 7D
Derriford Hospital
Plymouth, PL6 8DH
Australia2 sites
Austin Health
Heidelberg, VIC 3084
Linear Clinical Research Limited
Nedlands, 6009
Finland2 sites
Kuopio University Hospital
Kuopio, 70210
HUS Cancer Center
Lahti, 15850
About this study
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)
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:
Read more
- 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.
Read the detailed description
A Phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab in combination with other standard of care (SOC) agents in participants with B-NHL.
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
- Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
- Being tested
- rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, rituximab and lenalidomide, rituximab and bendamustine, rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin, gemcitabine and oxaliplatin
- Keywords
- DuoBody®, monoclonal antibodies, anti-CD3, anti-CD20
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisoneDrug
Also called R-CHOP
6 cycles (21-day cycles)
rituximab and lenalidomideDrug
Also called R2
rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles)
rituximab and bendamustineDrug
Also called BR
6 cycles (28-day cycles)
rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatinDrug
Also called R-DHAX/C
3 cycles (21-day cycles)
gemcitabine and oxaliplatinDrug
Also called GemOx
4 cycles (28-day cycles)
EpcoritamabBiological
Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™
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 prednisoneDrug
Also called R mini-CHOP
6 cycles (21-day cycles)
LenalidomideDrug
12 cycles (28-day cycles)
rituximab, ifosfamide, carboplatin, and etoposide phosphateDrug
Also called R-ICE
3 cycles (21-day cycles)
EpcoritamabBiological
Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
EpcoritamabBiological
Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
EpcoritamabBiological
Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
EpcoritamabBiological
Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™
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.
EpcoritamabBiological
Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
EpcoritamabBiological
Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
EpcoritamabBiological
Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™
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 LenalidomideDrug
Also called R2
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.
EpcoritamabBiological
Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Epcoritamab + R-CHOP | Experimental | In participants with previously untreated DLBCL. Receives: Drug: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; Biological: Epcoritamab |
| Arm 2 - Epcoritamab + R2 | Experimental | In participants with R/R FL. Receives: Biological: Epcoritamab; Drug: Rituximab and Lenalidomide |
| Arm 3 - Epcoritamab + BR | Experimental | In participants with previously untreated FL. Receives: Drug: rituximab and bendamustine; Biological: Epcoritamab |
| Arm 4 - Epcoritamab + R-DHAX/C | Experimental | In participants with R/R DLBCL eligible for ASCT. Receives: Drug: rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin; Biological: Epcoritamab |
| Arm 5 - Epcoritamab + GemOx | Experimental | In participants with R/R DLBCL ineligible ASCT. Receives: Drug: gemcitabine and oxaliplatin; Biological: Epcoritamab |
| Arm 6 - Epcoritamab + R2 | Experimental | In participants with previously untreated FL. Receives: Drug: rituximab and lenalidomide; Biological: Epcoritamab |
| Arm 7 - Epcoritamab maintenance | Experimental | In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L. Receives: Biological: Epcoritamab |
| Arm 8 - Epcoritamab + R mini-CHOP | Experimental | In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline. Receives: Drug: rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone; Biological: Epcoritamab |
| Arm 9 - Epcoritamab + Lenalidomide | Experimental | In participants with R/R FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy. Receives: Drug: Lenalidomide; Biological: Epcoritamab |
| Arm 10 - Epcoritamab + R-ICE | Experimental | In participants with R/R DLBCL eligible for ASCT. Receives: Drug: rituximab, ifosfamide, carboplatin, and etoposide phosphate; Biological: Epcoritamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Dose limiting Toxicities (DLTs)
DLT events are defined as clinically significant adverse events (AEs) or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications as assessed per Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
Measured: During the first cycle (Cycle length= 28 days) in each cohort
Part 1 and Part 2 (Arms 1-5, 7 and 10): Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign. (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From first dose of drug until either 60 days after last dose, date participant withdraws consent, date participant starts a new systemic anticancer therapy, or date participant dies, whichever occurs first (up to approximately 3 years)
Part 2 (Except Arm 7): Overall Response Rate (ORR)
ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.
Measured: Up to 3 years
Secondary outcomes (24)
Part 1 and 2: Clearance (CL) of Epcoritamab
Measured: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) of Epcoritamab
Measured: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Maximum (Peak) Plasma Concentration (Cmax) of Epcoritamab
Measured: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Time to Reach Cmax (Tmax) of Epcoritamab
Measured: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Terminal Elimination Half-Life (t 1/2) of Epcoritamab
Measured: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Number of Immune Cell Populations
Immune cell populations in peripheral blood and tumor biopsies will be assessed.
Measured: Up to 2 years
Part 1 and 2: Percentage of Immune Cell Populations
Immune cell populations in peripheral blood and tumor biopsies will be assessed.
Measured: Up to 2 years
Part 1 and 2: Change From Baseline in Cytokine Levels up to Cycle 3
Change in cytokine levels in peripheral blood samples will be assessed.
Measured: Up to Cycle 3 (cycle length = 21 days for Arms 1, 4, 8 and 10; cycle length = 28 days for Arms 2, 3, 5, 6 and 9; cycle length = 28 days (Cycle 1) and 56 days (Cycles 2, 3) for Arm 7)
Part 1 and 2: Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (DNA) Level up to End of Treatment (up to 2 Years)
Change in circulating tumor DNA levels will be assessed.
Measured: Up to 2 years
Part 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Epcoritamab
Measured: Up to 3 years
Part 1: ORR
ORR is defined as the percentage of participants achieving CR or PR based on Lugano criteria.
Measured: Up to 3 years
Part 1 and 2: Duration of Response (DOR)
DOR: the time from the first documentation of objective tumor response (CR or PR) to the date of first PD or death, whichever occurs earlier, based on Lugano criteria.
Measured: Up to 3 years
Part 1 and 2: Time to Response (TTR)
TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (CR or PR).
Measured: Up to 3 years
Part 1 and 2: Progression Free Survival (PFS)
PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier, based on Lugano criteria.
Measured: Up to 3 years
Part 1 and 2: Overall Survival (OS)
OS is defined as the time from the date of first dose, to the date of death due to any cause.
Measured: Up to 3 years
Part 1 and 2: Time to Next Anti-lymphoma Therapy (TTNT)
TTNT is defined as the time from Day 1 of Cycle 1 to first documented administration of subsequent anti-lymphoma therapy.
Measured: Up to 3 years
Part 1 and 2: Percentage of Participants With Minimal Residual Disease (MRD) Negativity
It is defined as the percentage of participants with at least 1 MRD negative result.
Measured: Up to 3 years
Part 1 and 2: Duration of minimal residual disease (MRD) negativity
Measured: Up to 3 years
Part 2 (Arm 7): Percentage of Participants Who Converted From MRD Positivity to MRD Negativity
Measured: Up to 3 years
Part 2 (Except Arm 7): Percentage of Participants with Complete Response (CR) in Arms 1 to 10
Measured: Up to 3 years
Part 2 (Arm 7): Percentage of Participants With CR
It is defined as the percentage of participants who remain in complete remission or converting to complete remission after first trial drug administration.
Measured: Week 24, Week 48, and Week 96
Part 1 and 2: Time to Complete Response (TTCR)
TTCR is defined as the time from first trial drug administration to the date of first documented complete response post-treatment.
Measured: Up to 3 years
Part 1 and 2: Duration of Complete Response (DoCR)
DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs first based on Lugano criteria.
Measured: Up to 3 years
Part 2: Number of Participants with AEs (Except Arm 7)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign. (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From first dose of drug until either 60 days after last dose, date participant withdraws consent, date participant starts a new systemic anticancer therapy, or date participant dies, whichever occurs first (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start3 Nov 2020
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 543 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663347
- Sponsor's protocol ID
- GCT3013-02
- Other IDs
- 2023-504805-35-00, 2020-000845-15, NL74222.056.20, 283235, RECF4377, 2023
- Acronym
- EPCORE™ NHL-2
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2020
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Publications
Falchi L, Vermaat JSP, Brody JD, Leslie L, Offner F, Christensen JH, Nijland M, Belada D, Wahlin BE, Drott K, Gomez Prieto P, Kopeckova K, Garcia-Sancho AM, Mei JP, Altintas I, Risum M, Reilly A, Zou J, Abrisqueta P. Epcoritamab with rituximab and lenalidomide as first-line treatment for follicular lymphoma (EPCORE NHL-2): an open-label, multicentre, phase 1/2 b trial. Lancet Haematol. 2026 Sep;13(9):e614-e625. doi: 10.1016/S2352-3026(26)00198-5.
PubMed 42660129Falchi L, Offner F, de Vos S, Brody JD, Morillo D, Linton K, Snauwaert S, Roost Clausen M, Karimi YH, Thieblemont C, Vitolo U, Leslie LA, Narkhede MS, Cordoba R, Oki T, Wielgos-Bonvallet M, Khoshdeli M, Hao Y, Archer K, Risum M, Belada D. Fixed-duration epcoritamab plus R-CHOP in newly diagnosed LBCL with IPI score 3-5: results from the EPCORE NHL-2 trial. Blood. 2026 Aug 11:blood.2026033839. doi: 10.1182/blood.2026033839. Online ahead of print.
PubMed 42622258Abrisqueta P, Karimi YH, Morillo D, Cordoba R, Phillips T, De Vos S, Nijland M, Offner F, Andersson PO, Brody J, Cheah CY, Prieto PG, Hellstrom M, Jorgensen JM, Lewis D, Linton KM, Musuraca G, Wang L, Marek J, Osei-Bonsu K, Risum M, Falchi L. Epcoritamab plus rituximab, dexamethasone, cytarabine, oxaliplatin/carboplatin induces deep and durable responses in transplant-eligible patients with relapsed or refractory diffuse large B-cell lymphoma: results from the EPCORE NHL-2 trial. Haematologica. 2026 Oct 1;111(10):3346-3357. doi: 10.3324/haematol.2025.300086. Epub 2026 Mar 5.
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