Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (EPCORE™ NHL-2)
Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
About this trial
This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring DuoBody®, monoclonal antibodies, anti-CD3, anti-CD20
Eligibility Criteria
Key Inclusion Criteria
- Subject must sign an Informed Consent Form (ICF)
- At least 18 years of age
- 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)
- 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 subject 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 Documented diffuse large B-cell lymphoma (DLBCL)
- DLBCL, 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 DLBCL and eligible for HDT-ASCT
- DLBCL, NOS
- "double-hit" or "triple-hit" DLBCL
- FL Grade 3B
Arm 5:
- Relapsed or refractory documented 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:
- DLBCL, NOS
- T-cell/histiocyte rich DLBCL
- "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 30 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
- Active 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.
Sites / Locations
- University of Alabama at BirminghamRecruiting
- Cedars-Sinai Medical CenterRecruiting
- David Geffen School of Medicine at UCLARecruiting
- University of California San FranciscoRecruiting
- Dana Farber Cancer InstituteRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- John Theurer Cancer Center at Hackensack UMCRecruiting
- Mount SinaiRecruiting
- Memorial Sloan Kettering CCRecruiting
- Levine Cancer CenterRecruiting
- UMPC Hillman Cancer Center Cancer PavillionRecruiting
- UT Southwestern Medical CenterRecruiting
- Monash Medical Centre
- Austin HealthRecruiting
- Linear Clinical Research LimitedRecruiting
- AZ Sint-JanRecruiting
- Universitair Ziekenhuis GentRecruiting
- CHU UCL Namur Site GodinneRecruiting
- Fakultni nemocnice Hradec KraloveRecruiting
- Fakultni nemocnice OstravaRecruiting
- Fakultni nemocnice v MotoleRecruiting
- Vseobecna Fakultni NemocniceRecruiting
- Århus HospitalRecruiting
- RigshospitaletRecruiting
- Odense University HospitalRecruiting
- Vejle SygehusRecruiting
- Tampere University HospitalRecruiting
- Kuopio University HospitalRecruiting
- HUS Cancer CenterRecruiting
- Institut BergoniéRecruiting
- CHU Dijon - Hopital du BocageRecruiting
- Hopital Claude Huriez - CHRU LilleRecruiting
- Hôpital de la TimoneRecruiting
- Hôpital Saint-LouisRecruiting
- Centre Hospitalier Lyon SudRecruiting
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)Recruiting
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCSRecruiting
- Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCSRecruiting
- Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei TumoriRecruiting
- Fondazione IRCCS CA' Granda Ospedale Maggiore PoliclinicoRecruiting
- Fondazione IRCCS Policlinico San MatteoRecruiting
- Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio EmiliaRecruiting
- Amsterdam UMC, Locatie VUMCRecruiting
- Universitair Medisch Centrum Groningen (UMCG)Recruiting
- Leids Universitair Medisch CentrumRecruiting
- Maastricht University Medical CenterRecruiting
- Erasmus Medisch CentrumRecruiting
- UMC UtrechtRecruiting
- Oslo Universitetssykehus HF, RadiumhospitaletRecruiting
- ICO l HospitaletRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Hospital Universitario Fundacion Jimenez DiazRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Universitario de SalamancaRecruiting
- Södra Älvsborgs SjukhusRecruiting
- Sahlgrenska SjukhusetRecruiting
- Skånes UniversitetssjukhusRecruiting
- Karolinska UniversitetssjukhusetRecruiting
- Norrlands UniversitetssjukhusRecruiting
- Akademiska SjukhusetRecruiting
- University College London Hospitals
- The Christie NHS Foundation TrustRecruiting
- Freeman HospitalRecruiting
- Derriford HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm 1 - Epcoritamab + R-CHOP
Arm 2 - Epcoritamab + R2
Arm 3 - Epcoritamab + BR
Arm 4 - Epcoritamab + R-DHAX/C
Arm 5 - Epcoritamab + GemOx
Arm 6 - Epcoritamab + R2
Arm 7 - Epcoritamab maintenance
Arm 8 - Epcoritamab + R mini-CHOP
Arm 9 - Epcoritamab + Lenalidomide
Arm 10 - Epcoritamab + R-ICE
In participants with previously untreated DLBCL.
In participants with R/R FL.
In participants with previously untreated FL.
In participants with R/R DLBCL eligible for ASCT.
In participants with R/R DLBCL ineligible ASCT.
In participants with previously untreated FL.
In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L.
In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline.
In participants with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy.
In participants with R/R DLBCL eligible for ASCT.