Zkouška bezpečnosti a účinnosti kombinací epcoritamabu u pacientů s B-buněčným non-Hodgkinovým lymfomem (B-NHL) (EPCORE™ NHL-2)
Fáze 1b/2, otevřená studie k posouzení bezpečnosti a předběžné účinnosti Epcoritamabu (GEN3013; DuoBody®-CD3xCD20) v kombinaci s jinými látkami u pacientů s B-buněčným non-Hodgkinovým lymfomem (B-NHL)
The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating participants with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to identify the most appropriate dose of epcoritamab, and the aim of the second part of the trial is to assess the selected epcoritamab dose in a larger group of participants with B-NHL. All participants in this trial will receive either epcoritamab alone, or epcoritamab combined with another standard treatment regimen, with a total of 10 different treatment arms being studied.
Trial details include:
- 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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
- Lék: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
- Biologický: Epcoritamab
- Biologický: Epcoritamab
- Biologický: Epcoritamab
- Biologický: Epcoritamab
- Biologický: Epcoritamab
- Biologický: Epcoritamab
- Biologický: Epcoritamab
- Biologický: Epcoritamab
- Biologický: Epcoritamab
- Lék: Rituximab and Lenalidomide
- Lék: rituximab and bendamustine
- Lék: rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
- Lék: gemcitabine and oxaliplatin
- Lék: rituximab and lenalidomide
- Lék: rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
- Lék: Lenalidomide
- Lék: rituximab, ifosfamide, carboplatin, and etoposide phosphate
Detailní popis
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.
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 2
- Fáze 1
Rozšířený přístup
Rozšířený přístup
Schválený
- Dostupné: Pro tuto zkoumanou léčbu je v současné době k dispozici rozšířený přístup a pacienti, kteří nejsou účastníky klinické studie, mohou získat přístup k léku, biologickému nebo lékařskému zařízení. právě se studuje.
- Již není k dispozici: Rozšířený přístup byl pro tento zásah k dispozici dříve, ale v současnosti není dostupný a nebude dostupný ani v budoucnu.
- Dočasně nedostupné: Rozšířený přístup není v současné době pro tento zásah k dispozici, ale očekává se, že bude dostupný v budoucnu.
- Schváleno pro marketing: Zásah byla schválena americkým Úřadem pro kontrolu potravin a léčiv pro použití veřejností.
Kontakty a umístění
Studijní místa
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Heidelberg, Austrálie, VIC 3084
- Austin Health
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Nedlands, Austrálie, 6009
- Linear Clinical Research Limited
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Bruges, Belgie, 8000
- AZ Sint-Jan
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Ghent, Belgie, 9000
- Universitair Ziekenhuis Gent
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Yvoir, Belgie, 5530
- CHU UCL Namur Site Godinne
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Aarhus, Dánsko
- Århus Hospital
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Copenhagen, Dánsko, 2100
- Rigshospitalet
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Odense, Dánsko
- Odense University Hospital
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Vejle, Dánsko
- Vejle Sygehus
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Kuopio, Finsko, 70210
- Kuopio University Hospital
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Lahti, Finsko, 15850
- HUS Cancer Center
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Lille, Francie, 59037
- Hopital Claude Huriez - CHRU Lille
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Marseille, Francie, 13005
- Hôpital de la Timone
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Paris, Francie, 75475
- Hôpital Saint-Louis
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Pierre-Bénite, Francie, 69495
- Centre Hospitalier Lyon Sud
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Amsterdam, Holandsko, 1105 AZ
- Amsterdam UMC, Locatie VUMC
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Groningen, Holandsko, 9713
- Universitair Medisch Centrum Groningen (UMCG)
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Leiden, Holandsko, 2333 ZA
- Leids Universitair Medisch Centrum
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Maastricht, Holandsko, 6229 HX
- Maastricht University Medical Center
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Rotterdam, Holandsko
- Erasmus Medisch Centrum
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Utrecht, Holandsko, 3584
- UMC Utrecht
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Bergamo, Itálie, 24127
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
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Bologna, Itálie
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
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Candiolo, Itálie, 10060
- Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS
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Meldola, Itálie, 47014
- IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
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Milan, Itálie, 20122
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
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Pavia, Itálie, 27100
- Fondazione IRCCS Policlinico San Matteo
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Reggio Emilia, Itálie, 42123
- Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
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Oslo, Norsko, 310
- Oslo Universitetssykehus HF, Radiumhospitalet
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Manchester, Spojené království
- The Christie Hospital
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Newcastle upon Tyne, Spojené království, NE7 7D
- Freeman Hospital
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Plymouth, Spojené království, PL6 8DH
- Derriford Hospital
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Alabama
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Birmingham, Alabama, Spojené státy, 35294
- University of Alabama at Birmingham
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California
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Los Angeles, California, Spojené státy, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Spojené státy, 90095
- David Geffen School of Medicine at UCLA
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San Francisco, California, Spojené státy, 94143
- University of California San Francisco
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02215
- Dana Farber Cancer Institute
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109
- University of Michigan Comprehensive Cancer Center Michigan Medicine
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New Jersey
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Hackensack, New Jersey, Spojené státy, 07601
- Hackensack University Medical Center
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New York
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New York, New York, Spojené státy, 10029
- Mount Sinai
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New York, New York, Spojené státy, 10065
- Memorial Sloan Kettering CC
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28204
- Levine Cancer Center
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Texas
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Dallas, Texas, Spojené státy, 75390
- Southwestern Medical Center
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Hradec Králové, Česko
- Fakultni nemocnice Hradec Kralove
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Ostrava - Poruba, Česko
- Fakultni nemocnice Ostrava
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Prague, Česko, 15006
- Fakultni nemocnice v Motole
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Prague, Česko
- Vseobecna Fakultni Nemocnice
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Barcelona, Španělsko, 8035
- Hospital Universitari Vall d'Hebron
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Barcelona, Španělsko, 08908
- ICO l Hospitalet
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Madrid, Španělsko, 28046
- Hospital Universitario La Paz
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Madrid, Španělsko, 28040
- Hospital Universitario Fundacion Jimenez Diaz
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Salamanca, Španělsko, 37007
- Hospital Universitario de Salamanca
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Borås, Švédsko
- Södra Älvsborgs Sjukhus
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Gothenburg, Švédsko, 413 45
- Sahlgrenska Sjukhuset
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Lund, Švédsko
- Skånes Universitetssjukhus
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Solna, Švédsko
- Karolinska Universitetssjukhuset
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Uppsala, Švédsko
- Akademiska Sjukhuset
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
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Experimentální: Arm 1 - Epcoritamab + R-CHOP
In participants with previously untreated DLBCL. |
6 cycles (21-day cycles)
Ostatní jména:
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.
Ostatní jména:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Ostatní jména:
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.
Ostatní jména:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
Ostatní jména:
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.
Ostatní jména:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
Ostatní jména:
|
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Experimentální: 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.
Ostatní jména:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Ostatní jména:
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.
Ostatní jména:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
Ostatní jména:
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.
Ostatní jména:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
Ostatní jména:
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.
Ostatní jména:
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Experimentální: 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.
Ostatní jména:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Ostatní jména:
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.
Ostatní jména:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
Ostatní jména:
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.
Ostatní jména:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
Ostatní jména:
6 cycles (28-day cycles)
Ostatní jména:
|
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Experimentální: 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.
Ostatní jména:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Ostatní jména:
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.
Ostatní jména:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
Ostatní jména:
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.
Ostatní jména:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
Ostatní jména:
3 cycles (21-day cycles)
Ostatní jména:
|
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Experimentální: 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.
Ostatní jména:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Ostatní jména:
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.
Ostatní jména:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
Ostatní jména:
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.
Ostatní jména:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
Ostatní jména:
4 cycles (28-day cycles)
Ostatní jména:
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Experimentální: 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.
Ostatní jména:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Ostatní jména:
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.
Ostatní jména:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
Ostatní jména:
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.
Ostatní jména:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
Ostatní jména:
rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles)
Ostatní jména:
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Experimentální: 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.
Ostatní jména:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Ostatní jména:
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.
Ostatní jména:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
Ostatní jména:
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.
Ostatní jména:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
Ostatní jména:
|
|
Experimentální: 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.
Ostatní jména:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Ostatní jména:
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.
Ostatní jména:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
Ostatní jména:
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.
Ostatní jména:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
Ostatní jména:
6 cycles (21-day cycles)
Ostatní jména:
|
|
Experimentální: 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.
Ostatní jména:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Ostatní jména:
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.
Ostatní jména:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
Ostatní jména:
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.
Ostatní jména:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
Ostatní jména:
12 cycles (28-day cycles) |
|
Experimentální: 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.
Ostatní jména:
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Ostatní jména:
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.
Ostatní jména:
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Ostatní jména:
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.
Ostatní jména:
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.
Ostatní jména:
Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.
Ostatní jména:
3 cycles (21-day cycles)
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Part 1: Number of Participants With Dose limiting Toxicities (DLTs)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Část 1 a 2: Clearance (CL) epcoritamabu
Časové okno: Před podáním a po dávce v několika časových bodech až do ukončení léčby (až 3 roky)
|
Před podáním a po dávce v několika časových bodech až do ukončení léčby (až 3 roky)
|
|
|
Část 1 a 2: Maximální (vrcholová) plazmatická koncentrace (Cmax) epcoritamabu
Časové okno: Před podáním a po dávce v několika časových bodech až do ukončení léčby (až 3 roky)
|
Před podáním a po dávce v několika časových bodech až do ukončení léčby (až 3 roky)
|
|
|
Část 1 a 2: Čas k dosažení Cmax (Tmax) epcoritamabu
Časové okno: Před podáním a po dávce v několika časových bodech až do ukončení léčby (až 3 roky)
|
Před podáním a po dávce v několika časových bodech až do ukončení léčby (až 3 roky)
|
|
|
Část 1 a 2: Terminální eliminační poločas (t 1/2) epcoritamabu
Časové okno: Před podáním a po dávce v několika časových bodech až do ukončení léčby (až 3 roky)
|
Před podáním a po dávce v několika časových bodech až do ukončení léčby (až 3 roky)
|
|
|
Část 1 a 2: Počet účastníků s protilátkami proti drogám (ADA) proti epcoritamabu
Časové okno: Do 3 let
|
Do 3 let
|
|
|
Část 1 a 2: Doba trvání negativity minimální reziduální choroby (MRD).
Časové okno: Do 3 let
|
Do 3 let
|
|
|
Část 2 (rameno 7): Procento účastníků, kteří konvertovali z MRD pozitivity na MRD negativitu
Časové okno: Do 3 let
|
Do 3 let
|
|
|
Část 2 (kromě skupiny 7): Procento účastníků s kompletní odpovědí (CR) ve skupinách 1 až 10
Časové okno: Do 3 let
|
Do 3 let
|
|
|
Část 1 a 2: Plocha pod křivkou koncentrace času (AUC) Epcoritamab
Časové okno: Předpokládat a podobate na více časových bodů až do přerušení léčby (až 3 roky)
|
Předpokládat a podobate na více časových bodů až do přerušení léčby (až 3 roky)
|
|
|
Part 1 and 2: Number of Immune Cell Populations
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: Up to 2 years
|
Change in circulating tumor DNA levels will be assessed. |
Up to 2 years
|
|
Part 1: ORR
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- 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.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Novotvary
- Onemocnění imunitního systému
- Novotvary podle histologického typu
- Lymfatická onemocnění
- Lymfoproliferativní poruchy
- Imunoproliferativní poruchy
- Lymfom, Non-Hodgkin
- Lymfom, B-buňka
- Lymfom
- Hemická a lymfatická onemocnění
- Lymfom, velký B-buňka, difuzní
- Lymfom, folikulární
- Aminokyseliny, peptidy a proteiny
- Proteiny
- Organické chemikálie
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Benzimidazoly
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Nukleové kyseliny, nukleotidy a nukleosidy
- Uhlovodíky
- Uhlovodíky, cyklické
- Uhlohydráty
- Kyseliny, acyklické
- Karboxylové kyseliny
- Alkaloidy
- Polycyklické aromatické uhlovodíky
- Uhlovodíky, aromatické
- Polycyklické sloučeniny
- Glykosidy
- Piperidiny
- Indoly
- Protilátky, monoklonální
- Protilátky
- Imunoglobuliny
- Imunoproteiny
- Krevní proteiny
- Sérové globuliny
- Globuliny
- Koordinační komplexy
- Deoxycytidin
- Cytidin
- Pyrimidinové nukleosidy
- Pyrimidiny
- Těhotenství
- Těhotenství
- Steroidy
- Sloučeniny roztaveného kruhu
- Steroidy, fluorované
- Fosforamidové hořčice
- Sloučeniny hořčice dusíku
- Hořčičné sloučeniny
- Uhlovodíky, halogenované
- Fosforamidy
- Organofosforové sloučeniny
- Nukleosidy
- Těhotenství
- Těhotenství
- Vinca alkaloidy
- Alkaloidy tryptaminu sezologaninu
- Indolské alkaloidy
- Indolizidiny
- Indoliziny
- Arabinonukleosidy
- Antracykliny
- Nafthacenes
- Aminoglykosidy
- Butyráty
- Protilátky, monoklonální, omyl odvozený
- Daunorubicin
- Oxaziny
- Fthalimidy
- Kyseliny ftalové
- Kyseliny, karbocyklické
- Piperidony
- Isoindoly
- Lenalidomid
- Oxaliplatina
- Bendamustin hydrochlorid
- Rituximab
- Gemcitabin
- Dexamethason
- Prednison
- Cyklofosfamid
- Cytarabin
- Karboplatina
- Doxorubicin
- Vinkristine
- Ifosfamid
- Etoposid fosfát
- Protokol R-CHOP
Další identifikační čísla studie
Další identifikační čísla studie
- GCT3013-02
- 2020-000845-15 (Číslo EudraCT)
- NL74222.056.20 (Identifikátor registru: CCMO)
- 283235 (Jiný identifikátor: IRAS ID; UK Research Summaries Database)
- RECF4377 (Jiný identifikátor: The French National Cancer Institute)
- 2023 (Grant/smlouva NIH USA)
- 2023-504805-35-00 (Ctis)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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