Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Epcoritamab · 2 trials · 10 indications
Using Common Terminology Criteria for Adverse Events version 5.0. Estimate safety and tolerability of combining epcoritamab with dose adjusted etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab.
Objective Response rate
| Arm | Type | Description |
|---|---|---|
| Treatment (Epcoritamab and EPOCH-R) | EXPERIMENTAL | Patients receive rituximab IV on day 1, prednisone PO BID on days 1-5, etoposide IV and doxorubicin on days 1-4 and cyclophosphamide IV on day 5 of each cycle. Patients also receive epcoritamab SC on days 8 and 15 of cycle 1, days 1, 8 and 15 of cycles 2-4 and day 1 of cycles 5-6. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MUGA scan or echocardiography during screening and receive fludeoxyglucose and undergo PET scan, CT scan, bone marrow biopsy and aspirate (if needed), and blood sample collection throughout the study. |
| experimental/epcoritamab | EXPERIMENTAL | Investigational Medicinal Product (IMP): Epcoritamab will be used during induction phase and Maintenance phase. Auxiliary Medicinal Products (AMP): Rituximab and Lenalidomide Standard use for AMP is: Induction: At cycle 1: Rituximab IV 375mg/m2 Day 1, 8, 15, 22; Lenalidomide 20mg oral route Day 1-Day 21 At cycle 2-3: Day 1: rituximab IV 375mg/m2; Lenalidomide 20mg oral route Day 1-Day 21 At cycle 4-8: Day 1: rituximab IV 375mg/m2; Lenalidomide 20mg oral route Day 1-Day 21 Maintenance: At cycle 9-20: Day 1: Lenalidomide 20mg oral route Day 1-D21 (12 cycles corresponding to one year of maintenance treatment) |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspiration | PROCEDURE | Undergo bone marrow aspiration |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Computed Tomography | PROCEDURE | Undergo CT scan |
| Cyclophosphamide | DRUG | Given IV |
| Doxorubicin | DRUG | Given IV |
| Echocardiography Test | PROCEDURE | Undergo echocardiography |
| Epcoritamab | BIOLOGICAL | Given SC |
| Etoposide | DRUG | Given IV |
| Fludeoxyglucose F-18 | OTHER | Given fludeoxyglucose |
| Multigated Acquisition Scan | PROCEDURE | Undergo MUGA scan |
| Positron Emission Tomography | PROCEDURE | Undergo PET scan |
| Prednisone | DRUG | Given PO |
| Rituximab | BIOLOGICAL | Given IV |
Inclusion Criteria: * Untreated aggressive large-B cell lymphoma (non-Hodgkin lymphoma) with adverse features that may predict sub-optimal response to R-CHOP and in the opinion of the investigator would be treated with dose adjusted (DA)-EPOCH-R as standard of care. Subjects must be planned to rece...
Epcoritamab is an investigational monoclonal antibody being studied for B-Cell Non-Hodgkin Lymphoma and Primary CNS Lymphoma (PCNSL). It is currently in Phase 2 clinical development for these oncology indications. The drug has received FDA designations including Priority Review, Breakthrough Therapy, and Accelerated Approval.
Epcoritamab targets MS4A1, CD3E, CD3G, and CD3D. It is a binding agent that engages these molecular targets, which are relevant to its mechanism of action in B-cell malignancies. The drug is being evaluated in clinical trials for B-Cell Non-Hodgkin Lymphoma and Primary CNS Lymphoma.
Epcoritamab is developed by AbbVie Inc. (ticker: ABBV). The company is conducting clinical trials of this investigational monoclonal antibody in oncology, specifically for B-Cell Non-Hodgkin Lymphoma and Primary CNS Lymphoma. The drug is currently in Phase 2 development.
Epcoritamab is in Phase 2 clinical development. It is an investigational drug, not yet approved, and is being studied for B-Cell Non-Hodgkin Lymphoma and Primary CNS Lymphoma. The FDA has granted it Priority Review, Breakthrough Therapy, and Accelerated Approval designations.
Epcoritamab is being studied in two Phase 2 trials. NCT06931652 is a study in relapsed/refractory Primary CNS Lymphoma with lenalidomide and rituximab, enrolling 60 participants in France. NCT07097363 is a study in aggressive B-Cell Non-Hodgkin Lymphoma with EPOCH-R, enrolling 18 participants in the United States.
Epcoritamab is a distinct investigational monoclonal antibody developed by AbbVie. It is being studied for B-Cell Non-Hodgkin Lymphoma and Primary CNS Lymphoma. No alternative names for this drug have been reported in clinical trial registrations.