B-세포 비호지킨 림프종(B-NHL) 환자에서 엡코리타맙 조합의 안전성 및 효능 시험 (EPCORE™ NHL-2)
B-세포 비호지킨 림프종(B-NHL) 피험자에서 다른 제제와 병용한 Epcoritamab(GEN3013; DuoBody®-CD3xCD20)의 안전성 및 예비 효능을 평가하기 위한 1b/2상 공개 라벨 시험
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.
연구 개요
상태
개입 / 치료
- 의약품: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
- 생물학적: Epcoritamab
- 생물학적: Epcoritamab
- 생물학적: Epcoritamab
- 생물학적: Epcoritamab
- 생물학적: Epcoritamab
- 생물학적: Epcoritamab
- 생물학적: Epcoritamab
- 생물학적: Epcoritamab
- 생물학적: Epcoritamab
- 의약품: Rituximab and Lenalidomide
- 의약품: rituximab and bendamustine
- 의약품: rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
- 의약품: gemcitabine and oxaliplatin
- 의약품: rituximab and lenalidomide
- 의약품: rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
- 의약품: Lenalidomide
- 의약품: rituximab, ifosfamide, carboplatin, and etoposide phosphate
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
확장된 액세스
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드, 1105 AZ
- Amsterdam UMC, Locatie VUMC
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Groningen, 네덜란드, 9713
- Universitair Medisch Centrum Groningen (UMCG)
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Leiden, 네덜란드, 2333 ZA
- Leids Universitair Medisch Centrum
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Maastricht, 네덜란드, 6229 HX
- Maastricht University Medical Center
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Rotterdam, 네덜란드
- Erasmus Medisch Centrum
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Utrecht, 네덜란드, 3584
- UMC Utrecht
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Oslo, 노르웨이, 310
- Oslo Universitetssykehus HF, Radiumhospitalet
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Aarhus, 덴마크
- Århus Hospital
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Copenhagen, 덴마크, 2100
- Rigshospitalet
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Odense, 덴마크
- Odense University Hospital
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Vejle, 덴마크
- Vejle Sygehus
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
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California
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Los Angeles, California, 미국, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, 미국, 90095
- David Geffen School of Medicine at UCLA
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San Francisco, California, 미국, 94143
- University of California San Francisco
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Dana Farber Cancer Institute
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan Comprehensive Cancer Center Michigan Medicine
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- Hackensack University Medical Center
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New York
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New York, New York, 미국, 10029
- Mount Sinai
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New York, New York, 미국, 10065
- Memorial Sloan Kettering CC
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North Carolina
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Charlotte, North Carolina, 미국, 28204
- Levine Cancer Center
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Texas
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Dallas, Texas, 미국, 75390
- Southwestern Medical Center
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Bruges, 벨기에, 8000
- AZ Sint-Jan
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Ghent, 벨기에, 9000
- Universitair Ziekenhuis Gent
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Yvoir, 벨기에, 5530
- CHU UCL Namur Site Godinne
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Borås, 스웨덴
- Södra Älvsborgs Sjukhus
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Gothenburg, 스웨덴, 413 45
- Sahlgrenska Sjukhuset
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Lund, 스웨덴
- Skånes Universitetssjukhus
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Solna, 스웨덴
- Karolinska Universitetssjukhuset
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Uppsala, 스웨덴
- Akademiska Sjukhuset
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Barcelona, 스페인, 8035
- Hospital Universitari Vall d'Hebron
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Barcelona, 스페인, 08908
- ICO l Hospitalet
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Madrid, 스페인, 28046
- Hospital Universitario La Paz
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Madrid, 스페인, 28040
- Hospital Universitario Fundacion Jimenez Diaz
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Salamanca, 스페인, 37007
- Hospital Universitario de Salamanca
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Manchester, 영국
- The Christie Hospital
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Newcastle upon Tyne, 영국, NE7 7D
- Freeman Hospital
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Plymouth, 영국, PL6 8DH
- Derriford Hospital
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Bergamo, 이탈리아, 24127
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
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Bologna, 이탈리아
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
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Candiolo, 이탈리아, 10060
- Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS
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Meldola, 이탈리아, 47014
- IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
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Milan, 이탈리아, 20122
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
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Pavia, 이탈리아, 27100
- Fondazione IRCCS Policlinico San Matteo
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Reggio Emilia, 이탈리아, 42123
- Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
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Hradec Králové, 체코
- Fakultni nemocnice Hradec Kralove
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Ostrava - Poruba, 체코
- Fakultni nemocnice Ostrava
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Prague, 체코, 15006
- Fakultni nemocnice v Motole
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Prague, 체코
- Vseobecna Fakultni Nemocnice
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Lille, 프랑스, 59037
- Hopital Claude Huriez - CHRU Lille
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Marseille, 프랑스, 13005
- Hôpital de la Timone
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Paris, 프랑스, 75475
- Hôpital Saint-Louis
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Pierre-Bénite, 프랑스, 69495
- Centre Hospitalier Lyon Sud
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Kuopio, 핀란드, 70210
- Kuopio University Hospital
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Lahti, 핀란드, 15850
- HUS Cancer Center
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Heidelberg, 호주, VIC 3084
- Austin Health
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Nedlands, 호주, 6009
- Linear Clinical Research Limited
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm 1 - Epcoritamab + R-CHOP
In participants with previously untreated DLBCL. |
6 cycles (21-day cycles)
다른 이름들:
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.
다른 이름들:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
다른 이름들:
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.
다른 이름들:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
다른 이름들:
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.
다른 이름들:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
다른 이름들:
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.
다른 이름들:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
다른 이름들:
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.
다른 이름들:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
다른 이름들:
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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
다른 이름들:
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.
다른 이름들:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
다른 이름들:
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.
다른 이름들:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
다른 이름들:
6 cycles (28-day cycles)
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
다른 이름들:
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.
다른 이름들:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
다른 이름들:
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.
다른 이름들:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
다른 이름들:
3 cycles (21-day cycles)
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
다른 이름들:
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.
다른 이름들:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
다른 이름들:
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.
다른 이름들:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
다른 이름들:
4 cycles (28-day cycles)
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
다른 이름들:
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.
다른 이름들:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
다른 이름들:
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.
다른 이름들:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
다른 이름들:
rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles)
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
다른 이름들:
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.
다른 이름들:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
다른 이름들:
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.
다른 이름들:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
다른 이름들:
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.
다른 이름들:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
다른 이름들:
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.
다른 이름들:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
다른 이름들:
6 cycles (21-day cycles)
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
다른 이름들:
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.
다른 이름들:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
다른 이름들:
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.
다른 이름들:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
다른 이름들:
12 cycles (28-day cycles) |
|
실험적: 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.
다른 이름들:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
다른 이름들:
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.
다른 이름들:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
다른 이름들:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
다른 이름들:
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.
다른 이름들:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
다른 이름들:
3 cycles (21-day cycles)
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part 1: Number of Participants With Dose limiting Toxicities (DLTs)
기간: 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)
기간: 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)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
파트 1 및 2: Epcoritamab의 클리어런스(CL)
기간: 치료가 중단될 때까지(최대 3년) 여러 시점에서 투여 전 및 투여 후 투여
|
치료가 중단될 때까지(최대 3년) 여러 시점에서 투여 전 및 투여 후 투여
|
|
|
파트 1 및 2: Epcoritamab의 최대(피크) 혈장 농도(Cmax)
기간: 치료가 중단될 때까지(최대 3년) 여러 시점에서 투여 전 및 투여 후 투여
|
치료가 중단될 때까지(최대 3년) 여러 시점에서 투여 전 및 투여 후 투여
|
|
|
파트 1 및 2: Epcoritamab의 Cmax(Tmax) 도달 시간
기간: 치료가 중단될 때까지(최대 3년) 여러 시점에서 투여 전 및 투여 후 투여
|
치료가 중단될 때까지(최대 3년) 여러 시점에서 투여 전 및 투여 후 투여
|
|
|
파트 1 및 2: Epcoritamab의 말기 제거 반감기(t 1/2)
기간: 치료가 중단될 때까지(최대 3년) 여러 시점에서 투여 전 및 투여 후 투여
|
치료가 중단될 때까지(최대 3년) 여러 시점에서 투여 전 및 투여 후 투여
|
|
|
파트 1 및 2: Epcoritamab에 대한 항약물 항체(ADA)를 보유한 참가자 수
기간: 최대 3년
|
최대 3년
|
|
|
1부 및 2부: 최소 잔여 질병(MRD) 음성 기간
기간: 최대 3년
|
최대 3년
|
|
|
파트 2(Arm 7): MRD 양성에서 MRD 부정으로 전환한 참가자의 비율
기간: 최대 3년
|
최대 3년
|
|
|
2부(7군 제외): 1~10군에서 완전 반응(CR)을 보인 참가자의 비율
기간: 최대 3년
|
최대 3년
|
|
|
1 부 및 2 : Epcoritamab의 농도 시간 곡선 (AUC)에 따른 면적
기간: 치료 중단 (최대 3 년)까지 여러 시계에서 예방 및 우편 발사
|
치료 중단 (최대 3 년)까지 여러 시계에서 예방 및 우편 발사
|
|
|
Part 1 and 2: Number of Immune Cell Populations
기간: 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
기간: 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
기간: 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)
기간: Up to 2 years
|
Change in circulating tumor DNA levels will be assessed. |
Up to 2 years
|
|
Part 1: ORR
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 신생물
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 림프계 질환
- 림프 증식 장애
- 면역증식성 장애
- 림프종, 비호지킨
- 림프종, B세포
- 림프종
- 헴 및 림프병
- 림프종, 대형 B세포, 미만성
- 림프종, 여포성
- 아미노산, 펩티드 및 단백질
- 단백질
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- Benzimidazoles
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- 핵산, 뉴클레오티드 및 뉴 클레오 시드
- 탄화수소
- 탄화수소, 순환
- 탄수화물
- 산, acyclic
- 카르 복실 산
- 알칼로이드
- 다 환식 방향족 탄화수소
- 탄화수소, 방향족
- 다 환식 화합물
- 글리코 사이드
- 파이퍼 리딘
- 인돌
- 항체, 모노클로 날
- 항체
- 면역 글로불린
- 면역 단백질
- 혈액 단백질
- 혈청 글로불린
- 글로불린
- 조정 복합체
- 데 옥시 시티 딘
- 시티 딘
- 피리 미딘 뉴 클레오 시드
- 피리 미딘
- Pretadienes
- 임신
- 스테로이드
- 융합 링 화합물
- 스테로이드, 불소
- 포스 포 아미드 머스타드
- 질소 머스타드 화합물
- 겨자 화합물
- 탄화수소, 할로겐화
- 포스 포 아미드
- 유기 인 화합물
- 뉴 클레오 시드
- Pregnadienetriols
- Pregnadienediols
- Vinca 알칼로이드
- Secologanin Tryptamine 알칼로이드
- 인돌 알칼로이드
- 인돌리 지딘
- 인도인
- 아라비노 뉴 클레오 시드
- 안트라 사이클린
- 나프 타센
- 아미노 글리코 시드
- 부티레이트
- 항체, 모노클로 날, 뮤린 유래
- Daunorubicin
- 옥사 진
- 프탈리 미드
- 프탈산
- 산, 카르 보 사이 클릭
- 파이퍼리돈
- Isoindoles
- 레날리도마이드
- 옥살리플라틴
- 벤다무스틴 염산염
- 리툭시맙
- 젬시타빈
- 덱사메타손
- 프레드니손
- 시클로포스파미드
- 시타라빈
- 카르보플라틴
- 독소루비신
- 빈크리스틴
- 이포스파미드
- 에토 포 시드 포스페이트
- R-Chop 프로토콜
기타 연구 ID 번호
- GCT3013-02
- 2020-000845-15 (EudraCT 번호)
- NL74222.056.20 (레지스트리 식별자: CCMO)
- 283235 (기타 식별자: IRAS ID; UK Research Summaries Database)
- RECF4377 (기타 식별자: The French National Cancer Institute)
- 2023 (미국 NIH 보조금/계약)
- 2023-504805-35-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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