B細胞非ホジキンリンパ腫（B-NHL）の被験者におけるエプコリタマブ併用の安全性と有効性試験 (EPCORE™ NHL-2)
B細胞非ホジキンリンパ腫（B-NHL）の被験者における他の薬剤と組み合わせたエプコリタマブ（GEN3013; DuoBody®-CD3xCD20）の安全性と予備的有効性を評価する第1b / 2相非盲検試験
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.
調査の概要
状態
介入・治療
- 薬：rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
- 生物学的：Epcoritamab
- 生物学的：Epcoritamab
- 生物学的：Epcoritamab
- 生物学的：Epcoritamab
- 生物学的：Epcoritamab
- 生物学的：Epcoritamab
- 生物学的：Epcoritamab
- 生物学的：Epcoritamab
- 生物学的：Epcoritamab
- 薬：Rituximab and Lenalidomide
- 薬：rituximab and bendamustine
- 薬：rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
- 薬：gemcitabine and oxaliplatin
- 薬：rituximab and lenalidomide
- 薬：rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
- 薬：Lenalidomide
- 薬：rituximab, ifosfamide, carboplatin, and etoposide phosphate
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
アクセスの拡大
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- University of Alabama at Birmingham
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California
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Los Angeles、California、アメリカ、90048
- Cedars-Sinai Medical Center
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Los Angeles、California、アメリカ、90095
- David Geffen School of Medicine at UCLA
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San Francisco、California、アメリカ、94143
- University of California San Francisco
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Dana Farber Cancer Institute
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan Comprehensive Cancer Center Michigan Medicine
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New Jersey
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Hackensack、New Jersey、アメリカ、07601
- Hackensack University Medical Center
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New York
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New York、New York、アメリカ、10029
- Mount Sinai
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New York、New York、アメリカ、10065
- Memorial Sloan Kettering CC
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North Carolina
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Charlotte、North Carolina、アメリカ、28204
- Levine Cancer Center
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Texas
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Dallas、Texas、アメリカ、75390
- Southwestern Medical Center
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Manchester、イギリス
- The Christie Hospital
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Newcastle upon Tyne、イギリス、NE7 7D
- Freeman Hospital
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Plymouth、イギリス、PL6 8DH
- Derriford Hospital
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Bergamo、イタリア、24127
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
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Bologna、イタリア
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
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Candiolo、イタリア、10060
- Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS
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Meldola、イタリア、47014
- IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
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Milan、イタリア、20122
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
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Pavia、イタリア、27100
- Fondazione IRCCS Policlinico San Matteo
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Reggio Emilia、イタリア、42123
- Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
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Amsterdam、オランダ、1105 AZ
- Amsterdam UMC, Locatie VUMC
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Groningen、オランダ、9713
- Universitair Medisch Centrum Groningen (UMCG)
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Leiden、オランダ、2333 ZA
- Leids Universitair Medisch Centrum
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Maastricht、オランダ、6229 HX
- Maastricht University Medical Center
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Rotterdam、オランダ
- Erasmus Medisch Centrum
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Utrecht、オランダ、3584
- UMC Utrecht
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Heidelberg、オーストラリア、VIC 3084
- Austin Health
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Nedlands、オーストラリア、6009
- Linear Clinical Research Limited
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Borås、スウェーデン
- Södra Älvsborgs Sjukhus
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Gothenburg、スウェーデン、413 45
- Sahlgrenska Sjukhuset
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Lund、スウェーデン
- Skånes Universitetssjukhus
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Solna、スウェーデン
- Karolinska Universitetssjukhuset
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Uppsala、スウェーデン
- Akademiska Sjukhuset
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Barcelona、スペイン、8035
- Hospital Universitari Vall d'Hebron
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Barcelona、スペイン、08908
- ICO l Hospitalet
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Madrid、スペイン、28046
- Hospital Universitario La Paz
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Madrid、スペイン、28040
- Hospital Universitario Fundacion Jimenez Diaz
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Salamanca、スペイン、37007
- Hospital Universitario de Salamanca
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Hradec Králové、チェコ
- Fakultni nemocnice Hradec Kralove
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Ostrava - Poruba、チェコ
- Fakultni nemocnice Ostrava
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Prague、チェコ、15006
- Fakultni nemocnice v Motole
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Prague、チェコ
- Vseobecna Fakultni Nemocnice
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Aarhus、デンマーク
- Århus Hospital
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Copenhagen、デンマーク、2100
- Rigshospitalet
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Odense、デンマーク
- Odense University Hospital
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Vejle、デンマーク
- Vejle Sygehus
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Oslo、ノルウェー、310
- Oslo Universitetssykehus HF, Radiumhospitalet
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Kuopio、フィンランド、70210
- Kuopio University Hospital
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Lahti、フィンランド、15850
- HUS Cancer Center
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Lille、フランス、59037
- Hopital Claude Huriez - CHRU Lille
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Marseille、フランス、13005
- Hôpital de la Timone
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Paris、フランス、75475
- Hôpital Saint-Louis
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Pierre-Bénite、フランス、69495
- Centre Hospitalier Lyon Sud
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Bruges、ベルギー、8000
- AZ Sint-Jan
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Ghent、ベルギー、9000
- Universitair Ziekenhuis Gent
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Yvoir、ベルギー、5530
- CHU UCL Namur Site Godinne
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm 1 - Epcoritamab + R-CHOP
In participants with previously untreated DLBCL. |
6 cycles (21-day cycles)
他の名前：
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.
他の名前：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
他の名前：
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.
他の名前：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
他の名前：
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.
他の名前：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
他の名前：
|
|
実験的：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.
他の名前：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
他の名前：
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.
他の名前：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
他の名前：
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.
他の名前：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
他の名前：
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.
他の名前：
|
|
実験的：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.
他の名前：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
他の名前：
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.
他の名前：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
他の名前：
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.
他の名前：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
他の名前：
6 cycles (28-day cycles)
他の名前：
|
|
実験的：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.
他の名前：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
他の名前：
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.
他の名前：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
他の名前：
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.
他の名前：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
他の名前：
3 cycles (21-day cycles)
他の名前：
|
|
実験的：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.
他の名前：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
他の名前：
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.
他の名前：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
他の名前：
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.
他の名前：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
他の名前：
4 cycles (28-day cycles)
他の名前：
|
|
実験的：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.
他の名前：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
他の名前：
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.
他の名前：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
他の名前：
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.
他の名前：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
他の名前：
rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles)
他の名前：
|
|
実験的：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.
他の名前：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
他の名前：
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.
他の名前：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
他の名前：
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.
他の名前：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
他の名前：
|
|
実験的：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.
他の名前：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
他の名前：
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.
他の名前：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
他の名前：
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.
他の名前：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
他の名前：
6 cycles (21-day cycles)
他の名前：
|
|
実験的：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.
他の名前：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
他の名前：
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.
他の名前：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
他の名前：
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.
他の名前：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
他の名前：
12 cycles (28-day cycles) |
|
実験的：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.
他の名前：
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
他の名前：
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.
他の名前：
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
他の名前：
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
他の名前：
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.
他の名前：
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
他の名前：
3 cycles (21-day cycles)
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Part 1: Number of Participants With Dose limiting Toxicities (DLTs)
時間枠：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)
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
パート 1 および 2: エプコリタマブのクリアランス (CL)
時間枠：治療中止までの複数の時点での投与前および投与後（最長 3 年間）
|
治療中止までの複数の時点での投与前および投与後（最長 3 年間）
|
|
|
パート 1 および 2: エプコリタマブの最大 (ピーク) 血漿濃度 (Cmax)
時間枠：治療中止までの複数の時点での投与前および投与後（最長 3 年間）
|
治療中止までの複数の時点での投与前および投与後（最長 3 年間）
|
|
|
パート 1 および 2: エプコリタマブの Cmax (Tmax) に達するまでの時間
時間枠：治療中止までの複数の時点での投与前および投与後（最長 3 年間）
|
治療中止までの複数の時点での投与前および投与後（最長 3 年間）
|
|
|
パート 1 および 2: エプコリタマブの終末消去半減期 (t 1/2)
時間枠：治療中止までの複数の時点での投与前および投与後（最長 3 年間）
|
治療中止までの複数の時点での投与前および投与後（最長 3 年間）
|
|
|
パート 1 および 2: エプコリタマブに対する抗薬物抗体 (ADA) を有する参加者の数
時間枠：最長3年
|
最長3年
|
|
|
パート 1 および 2: 微小残存病変 (MRD) 陰性期間
時間枠：最長3年
|
最長3年
|
|
|
パート 2 (アーム 7): MRD 陽性反応から MRD 陰性反応に転換した参加者の割合
時間枠：最長3年
|
最長3年
|
|
|
パート 2 (アーム 7 を除く): アーム 1 ～ 10 で完全奏効 (CR) を示した参加者の割合
時間枠：最長3年
|
最長3年
|
|
|
パート1および2：エプコリタマブの濃度時間曲線（AUC）の下の面積
時間枠：治療の中止（最大3年）まで、複数の時点で事前にポストドーズします
|
治療の中止（最大3年）まで、複数の時点で事前にポストドーズします
|
|
|
Part 1 and 2: Number of Immune Cell Populations
時間枠：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
時間枠：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
時間枠：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)
時間枠：Up to 2 years
|
Change in circulating tumor DNA levels will be assessed. |
Up to 2 years
|
|
Part 1: ORR
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- 新生物
- 免疫系疾患
- 組織型別の新生物
- リンパ疾患
- リンパ増殖性疾患
- 免疫増殖性疾患
- リンパ腫、非ホジキン
- リンパ腫、B細胞
- リンパ腫
- ヘミックおよびリンパ疾患
- リンパ腫、大型B細胞、びまん性
- リンパ腫、濾胞性
- アミノ酸、ペプチド、およびタンパク質
- タンパク質
- 有機化学物質
- 複素環化化合物、1リング
- 複素環化化合物
- ベンジミダゾール
- 複素環化化合物、2リング
- 複素環化化合物、融合リング
- 核酸、ヌクレオチド、およびヌクレオシド
- 炭化水素
- 炭化水素、周期的
- 炭水化物
- 酸、非環式
- カルボン酸
- アルカロイド
- 多環芳香族炭化水素
- 炭化水素、芳香
- 多環式化合物
- グリコシド
- ピペリジン
- インドール
- 抗体、モノクローナル
- 抗体
- 免疫グロブリン
- 免疫タンパク質
- 血液タンパク質
- 血清グロブリン
- グロブリン
- 調整錯体
- デオキシシチジン
- シチジン
- ピリミジンヌクレオシド
- ピリミジン
- 妊娠
- 妊娠
- ステロイド
- 融合リング化合物
- ステロイド、フッ素化
- ホスホルアミドマスタード
- 窒素マスタード化合物
- マスタード化合物
- 炭化水素、ハロゲン化
- ホスホラミド
- 有機リン化合物
- ヌクレオシド
- 妊娠症
- 妊娠した
- ヴィンカアルカロイド
- セコロガニントリプタミンアルカロイド
- インドールアルカロイド
- インドリジジン
- インドリジン
- アラビノヌクレオシド
- アントラサイクリン
- ナフテセン
- アミノグリコシド
- 酪酸
- 抗体、モノクローナル、マウス由来
- ダウノルビシン
- オキサジン
- フタリミド
- フタル酸
- 酸、炭素環
- ピペリドン
- イソインドール
- レナリドミド
- オキサリプラチン
- ベンダムスチン塩酸塩
- リツキシマブ
- ゲムシタビン
- デキサメタゾン
- プレドニン
- シクロホスファミド
- シタラビン
- カルボプラチン
- ドキソルビシン
- ビンクリスチン
- イホスファミド
- エトポシドリン酸
- R-Chopプロトコル
その他の研究ID番号
- GCT3013-02
- 2020-000845-15 (EudraCT番号)
- NL74222.056.20 (レジストリ識別子：CCMO)
- 283235 (その他の識別子：IRAS ID; UK Research Summaries Database)
- RECF4377 (その他の識別子：The French National Cancer Institute)
- 2023 (米国 NIH グラント/契約)
- 2023-504805-35-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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