Epcoritamab 组合在 B 细胞非霍奇金淋巴瘤 (B-NHL) 受试者中的安全性和有效性试验 (EPCORE™ NHL-2)
评估 Epcoritamab（GEN3013；DuoBody®-CD3xCD20）与其他药物联合治疗 B 细胞非霍奇金淋巴瘤 (B-NHL) 患者的安全性和初步疗效的 1b/2 期开放标签试验
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.
研究概览
地位
干预/治疗
- 药品：rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
- 生物：Epcoritamab
- 生物：Epcoritamab
- 生物：Epcoritamab
- 生物：Epcoritamab
- 生物：Epcoritamab
- 生物：Epcoritamab
- 生物：Epcoritamab
- 生物：Epcoritamab
- 生物：Epcoritamab
- 药品：Rituximab and Lenalidomide
- 药品：rituximab and bendamustine
- 药品：rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
- 药品：gemcitabine and oxaliplatin
- 药品：rituximab and lenalidomide
- 药品：rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
- 药品：Lenalidomide
- 药品：rituximab, ifosfamide, carboplatin, and etoposide phosphate
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
扩展访问
联系人和位置
学习地点
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Aarhus、丹麦
- Århus Hospital
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Copenhagen、丹麦、2100
- Rigshospitalet
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Odense、丹麦
- Odense University Hospital
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Vejle、丹麦
- Vejle Sygehus
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Bergamo、意大利、24127
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
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Bologna、意大利
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
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Candiolo、意大利、10060
- Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS
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Meldola、意大利、47014
- IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
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Milan、意大利、20122
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
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Pavia、意大利、27100
- Fondazione IRCCS Policlinico San Matteo
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Reggio Emilia、意大利、42123
- Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
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Oslo、挪威、310
- Oslo Universitetssykehus HF, Radiumhospitalet
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Hradec Králové、捷克语
- Fakultni nemocnice Hradec Kralove
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Ostrava - Poruba、捷克语
- Fakultni nemocnice Ostrava
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Prague、捷克语、15006
- Fakultni nemocnice v Motole
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Prague、捷克语
- Vseobecna Fakultni Nemocnice
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Bruges、比利时、8000
- AZ Sint-Jan
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Ghent、比利时、9000
- Universitair Ziekenhuis Gent
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Yvoir、比利时、5530
- CHU UCL Namur Site Godinne
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Lille、法国、59037
- Hopital Claude Huriez - CHRU Lille
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Marseille、法国、13005
- Hôpital de la Timone
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Paris、法国、75475
- Hôpital Saint-Louis
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Pierre-Bénite、法国、69495
- Centre Hospitalier Lyon Sud
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Heidelberg、澳大利亚、VIC 3084
- Austin Health
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Nedlands、澳大利亚、6009
- Linear Clinical Research Limited
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Borås、瑞典
- Södra Älvsborgs Sjukhus
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Gothenburg、瑞典、413 45
- Sahlgrenska Sjukhuset
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Lund、瑞典
- Skånes Universitetssjukhus
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Solna、瑞典
- Karolinska Universitetssjukhuset
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Uppsala、瑞典
- Akademiska Sjukhuset
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
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California
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Los Angeles、California、美国、90048
- Cedars-Sinai Medical Center
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Los Angeles、California、美国、90095
- David Geffen School of Medicine at UCLA
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San Francisco、California、美国、94143
- University of California San Francisco
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Massachusetts
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Boston、Massachusetts、美国、02215
- Dana Farber Cancer Institute
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan Comprehensive Cancer Center Michigan Medicine
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New Jersey
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Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center
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New York
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New York、New York、美国、10029
- Mount Sinai
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New York、New York、美国、10065
- Memorial Sloan Kettering CC
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North Carolina
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Charlotte、North Carolina、美国、28204
- Levine Cancer Center
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Texas
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Dallas、Texas、美国、75390
- Southwestern Medical Center
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Kuopio、芬兰、70210
- Kuopio University Hospital
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Lahti、芬兰、15850
- HUS Cancer Center
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Manchester、英国
- The Christie Hospital
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Newcastle upon Tyne、英国、NE7 7D
- Freeman Hospital
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Plymouth、英国、PL6 8DH
- Derriford Hospital
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Amsterdam、荷兰、1105 AZ
- Amsterdam UMC, Locatie VUMC
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Groningen、荷兰、9713
- Universitair Medisch Centrum Groningen (UMCG)
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Leiden、荷兰、2333 ZA
- Leids Universitair Medisch Centrum
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Maastricht、荷兰、6229 HX
- Maastricht University Medical Center
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Rotterdam、荷兰
- Erasmus Medisch Centrum
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Utrecht、荷兰、3584
- UMC Utrecht
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Barcelona、西班牙、8035
- Hospital Universitari Vall d'Hebron
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Barcelona、西班牙、08908
- ICO l Hospitalet
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Madrid、西班牙、28046
- Hospital Universitario La Paz
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Madrid、西班牙、28040
- Hospital Universitario Fundacion Jimenez Diaz
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Salamanca、西班牙、37007
- Hospital Universitario de Salamanca
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria
- 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
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
- 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
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm 1 - Epcoritamab + R-CHOP
In participants with previously untreated DLBCL. |
6 cycles (21-day cycles)
其他名称：
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.
其他名称：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
其他名称：
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.
其他名称：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
其他名称：
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.
其他名称：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
其他名称：
|
|
实验性的：Arm 2 - Epcoritamab + R2
In participants with R/R FL. |
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.
其他名称：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
其他名称：
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.
其他名称：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
其他名称：
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.
其他名称：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
其他名称：
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.
其他名称：
|
|
实验性的：Arm 3 - Epcoritamab + BR
In participants with previously untreated FL. |
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.
其他名称：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
其他名称：
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.
其他名称：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
其他名称：
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.
其他名称：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
其他名称：
6 cycles (28-day cycles)
其他名称：
|
|
实验性的：Arm 4 - Epcoritamab + R-DHAX/C
In participants with R/R DLBCL eligible for ASCT. |
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.
其他名称：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
其他名称：
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.
其他名称：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
其他名称：
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.
其他名称：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
其他名称：
3 cycles (21-day cycles)
其他名称：
|
|
实验性的：Arm 5 - Epcoritamab + GemOx
In participants with R/R DLBCL ineligible ASCT. |
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.
其他名称：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
其他名称：
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.
其他名称：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
其他名称：
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.
其他名称：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
其他名称：
4 cycles (28-day cycles)
其他名称：
|
|
实验性的：Arm 6 - Epcoritamab + R2
In participants with previously untreated FL. |
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.
其他名称：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
其他名称：
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.
其他名称：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
其他名称：
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.
其他名称：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
其他名称：
rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles)
其他名称：
|
|
实验性的：Arm 7 - Epcoritamab maintenance
In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L. |
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.
其他名称：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
其他名称：
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.
其他名称：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
其他名称：
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.
其他名称：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
其他名称：
|
|
实验性的：Arm 8 - Epcoritamab + R mini-CHOP
In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline. |
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.
其他名称：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
其他名称：
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.
其他名称：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
其他名称：
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.
其他名称：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
其他名称：
6 cycles (21-day cycles)
其他名称：
|
|
实验性的：Arm 9 - Epcoritamab + Lenalidomide
In participants with R/R FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy. |
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.
其他名称：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
其他名称：
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.
其他名称：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
其他名称：
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.
其他名称：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
其他名称：
12 cycles (28-day cycles) |
|
实验性的：Arm 10 - Epcoritamab + R-ICE
In participants with R/R DLBCL eligible for ASCT. |
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.
其他名称：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
其他名称：
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.
其他名称：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
其他名称：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
其他名称：
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.
其他名称：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
其他名称：
3 cycles (21-day cycles)
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Part 1: Number of Participants With Dose limiting Toxicities (DLTs)
大体时间：During the first cycle (Cycle length= 28 days) in each cohort
|
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. |
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)
大体时间：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)
|
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. |
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)
大体时间：Up to 3 years
|
ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria. |
Up to 3 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
第 1 部分和第 2 部分：Epcoritamab 的清除 (CL)
大体时间：在多个时间点给药前和给药后直到治疗停止（长达 3 年）
|
在多个时间点给药前和给药后直到治疗停止（长达 3 年）
|
|
|
第 1 部分和第 2 部分：Epcoritamab 的最大（峰值）血浆浓度（Cmax）
大体时间：在多个时间点给药前和给药后直到治疗停止（长达 3 年）
|
在多个时间点给药前和给药后直到治疗停止（长达 3 年）
|
|
|
第 1 部分和第 2 部分：Epcoritamab 达到 Cmax (Tmax) 的时间
大体时间：在多个时间点给药前和给药后直到治疗停止（长达 3 年）
|
在多个时间点给药前和给药后直到治疗停止（长达 3 年）
|
|
|
第 1 部分和第 2 部分：Epcoritamab 的终末消除半衰期 (t 1/2)
大体时间：在多个时间点给药前和给药后直到治疗停止（长达 3 年）
|
在多个时间点给药前和给药后直到治疗停止（长达 3 年）
|
|
|
第 1 部分和第 2 部分：具有针对 Epcoritamab 的抗药物抗体 (ADA) 的参与者人数
大体时间：长达 3 年
|
长达 3 年
|
|
|
第 1 部分和第 2 部分：微小残留病 (MRD) 阴性的持续时间
大体时间：长达 3 年
|
长达 3 年
|
|
|
第 2 部分（第 7 组）：从 MRD 阳性转为 MRD 阴性的参与者百分比
大体时间：长达 3 年
|
长达 3 年
|
|
|
第 2 部分（第 7 组除外）：第 1 至 10 组完全响应 (CR) 的参与者百分比
大体时间：长达 3 年
|
长达 3 年
|
|
|
第1部分和第2部分：Epcoritamab的浓度时间曲线（AUC）下的面积
大体时间：在多个时间点上的predose和postdos，直到停用治疗（最多3年）
|
在多个时间点上的predose和postdos，直到停用治疗（最多3年）
|
|
|
Part 1 and 2: Number of Immune Cell Populations
大体时间：Up to 2 years
|
Immune cell populations in peripheral blood and tumor biopsies will be assessed. |
Up to 2 years
|
|
Part 1 and 2: Percentage of Immune Cell Populations
大体时间：Up to 2 years
|
Immune cell populations in peripheral blood and tumor biopsies will be assessed. |
Up to 2 years
|
|
Part 1 and 2: Change From Baseline in Cytokine Levels up to Cycle 3
大体时间：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)
|
Change in cytokine levels in peripheral blood samples will be assessed. |
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)
大体时间：Up to 2 years
|
Change in circulating tumor DNA levels will be assessed. |
Up to 2 years
|
|
Part 1: ORR
大体时间：Up to 3 years
|
ORR is defined as the percentage of participants achieving CR or PR based on Lugano criteria. |
Up to 3 years
|
|
Part 1 and 2: Duration of Response (DOR)
大体时间：Up to 3 years
|
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. |
Up to 3 years
|
|
Part 1 and 2: Time to Response (TTR)
大体时间：Up to 3 years
|
TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (CR or PR). |
Up to 3 years
|
|
Part 1 and 2: Progression Free Survival (PFS)
大体时间：Up to 3 years
|
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. |
Up to 3 years
|
|
Part 1 and 2: Overall Survival (OS)
大体时间：Up to 3 years
|
OS is defined as the time from the date of first dose, to the date of death due to any cause. |
Up to 3 years
|
|
Part 1 and 2: Time to Next Anti-lymphoma Therapy (TTNT)
大体时间：Up to 3 years
|
TTNT is defined as the time from Day 1 of Cycle 1 to first documented administration of subsequent anti-lymphoma therapy. |
Up to 3 years
|
|
Part 1 and 2: Percentage of Participants With Minimal Residual Disease (MRD) Negativity
大体时间：Up to 3 years
|
It is defined as the percentage of participants with at least 1 MRD negative result. |
Up to 3 years
|
|
Part 2 (Arm 7): Percentage of Participants With CR
大体时间：Week 24, Week 48, and Week 96
|
It is defined as the percentage of participants who remain in complete remission or converting to complete remission after first trial drug administration. |
Week 24, Week 48, and Week 96
|
|
Part 1 and 2: Time to Complete Response (TTCR)
大体时间：Up to 3 years
|
TTCR is defined as the time from first trial drug administration to the date of first documented complete response post-treatment. |
Up to 3 years
|
|
Part 1 and 2: Duration of Complete Response (DoCR)
大体时间：Up to 3 years
|
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. |
Up to 3 years
|
|
Part 2: Number of Participants with AEs (Except Arm 7)
大体时间：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)
|
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. |
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)
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- Falchi 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.
- Abrisqueta 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- 肿瘤
- 免疫系统疾病
- 组织学类型的肿瘤
- 淋巴系统疾病
- 淋巴增生性疾病
- 免疫增生性疾病
- 淋巴瘤，非霍奇金
- 淋巴瘤，B细胞
- 淋巴瘤
- 半身和淋巴疾病
- 淋巴瘤，大 B 细胞，弥漫性
- 淋巴瘤，滤泡性
- 氨基酸，肽和蛋白质
- 蛋白质
- 有机化学品
- 杂环化合物，1形
- 杂环化合物
- 苯甲酰唑
- 杂环化合物，2环
- 杂环化合物，融合环
- 核酸，核苷酸和核苷
- 碳氢化合物
- 碳氢化合物，循环
- 碳水化合物
- 酸，无环
- 羧酸
- 生物碱
- 多环芳烃
- 碳氢化合物，芳香族
- 多环化合物
- 糖苷
- 哌啶
- 吲哚
- 抗体，单克隆
- 抗体
- 免疫球蛋白
- 免疫蛋白
- 血蛋白
- 血清球蛋白
- 球蛋白
- 协调配合物
- 脱氧胞苷
- 胞苷
- 嘧啶核苷
- 嘧啶
- 怀孕
- 怀孕
- 类固醇
- 融合环化合物
- 类固醇，氟化
- 磷酰胺芥末
- 氮芥末化合物
- 芥末化合物
- 碳氢化合物，卤素
- 磷酰胺
- 有机磷化合物
- 核苷
- 疗法
- 妊娠二培养子
- VINCA生物碱
- Secologanin色素生物碱
- 吲哚生物碱
- 吲哚衍生物
- 吲哚王
- 阿拉伯核苷
- 蒽环类动物
- 萘烯
- 氨基糖苷
- 丁酸酯
- 抗体，单克隆，鼠的衍生
- Daunorubicin
- 奥沙嗪
- 邻苯二甲胺
- 邻苯二甲酸
- 酸，碳环
- 哌啶酮
- 等词
- 来那度胺
- 奥沙利铂
- 盐酸苯达莫司汀
- 利妥昔单抗
- 吉西他滨
- 地塞米松
- 强的松
- 环磷酰胺
- 阿糖胞苷
- 卡铂
- 阿霉素
- 长春新碱
- 异环磷酰胺
- 依托泊苷磷酸盐
- R-CHOP协议
其他研究编号
- GCT3013-02
- 2020-000845-15 (EudraCT编号)
- NL74222.056.20 (注册表标识符：CCMO)
- 283235 (其他标识符：IRAS ID; UK Research Summaries Database)
- RECF4377 (其他标识符：The French National Cancer Institute)
- 2023 (美国 NIH 拨款/合同)
- 2023-504805-35-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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