Brief Summary
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 subjects with B-cell non-Hodgkin Lymphomacancers of the lymphatic system (B-NHL). The aim of the first part of the trial is to identify the most appropriate dosethe amount of medication taken 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 total trial duration will be up to 6 years.
- The treatment duration for each participant depends upon which arm of treatment they are assigned to receive, but will be no more than 3 years.
- The visit frequency for each participant depends upon which arm of treatment they are assigned to receive, 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 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.
Intervention / Treatment
- Drug: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
- Drug: rituximab and lenalidomide
- Drug: rituximab and bendamustine
- Drug: rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
- Drug: gemcitabine and oxaliplatin
- Biological: Epcoritamab
- Drug: rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
- Drug: Lenalidomide
- Drug: rituximab, ifosfamide, carboplatin, and etoposide phosphate
- Biological: Epcoritamab
- Biological: Epcoritamab
- Biological: Epcoritamab
- Biological: Epcoritamab
- Biological: Epcoritamab
- Biological: Epcoritamab
- Biological: Epcoritamab
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 imagingtests that create detailed images of areas inside the body (MRI)
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) PS score of 0, 1 or 2
- Acceptable organ function at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening
- CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsyremoval of a section of tissue to analyse for cancer cells
- 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 DLBCL
- DLBCL, not otherwise specified (NOS)
- “Double-hit” or “triple-hit” DLBCL
- FL Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells 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