

GCT3013-05
A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma
Trial summary:
Phase 3 study of epcoritamab (GEN3013; DuoBody®-CD3xCD20) versus prespecified investigator’s choice of chemotherapy in patients with relapsed, refractory diffuse large B-Cell Lymphoma
Receptor status / problem studied:
Diffuse large B-cell lymphoma
Inclusion criteria
- Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since lymphoma diagnosis
- One of the confirmed histologies below with CD20-positivity:
- a. DLBCL, NOS, including de novo or histologically transformed from FL
- b. “”Double-hit”” or “”triple-hit”” DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL
- c. FL Grade 3B
- ECOG PS score of 0-2
- Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening
- Patients must have detectable disease by PET scan and measurable by CT scan or MRI
- Acceptable renal and liver function
- Life expectancy >2 months on SOC treatment
Exclusion criteria
- Primary CNS tumor or known CNS involvement
- Any prior therapy with a bispecific antibody targeting CD3 and CD20
- Major surgery within 4 weeks prior to randomization
- Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
- Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
- ASCT within 100 days of randomization
- Treatment with CAR-T therapy within 100 days prior to randomization
- Seizure disorder requiring anti-epileptic therapy
- Clinically significant cardiac disease
Open for recruitment
Trial Title
GCT3013-05
Diagnosis
Lymphoma – B-cell Non Hodgkin’s
Type of trial
Pharmaceutical
Type of treatement
Haematology
Phase
III
Locations
Investigators
Principal Investigator