A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL
About the study
The drug that will be investigated in the study is an antibody, epcoritamab, also known as EPKINLY™ and GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator's choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Main 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:
- DLBCL, NOS, including de novo or histologically transformed from FL
- "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
- FL Grade 3B
- T-cell/histiocyte-rich large B-cell lymphoma
- 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
Main Exclusion Criteria:
- Primary Central Nervous System (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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Diffuse Large B-cell Lymphoma
Age (in years)
18+
Phase
Phase 3
Participants needed
552
Est. Completion Date
Apr 30, 2028
Treatment type
Interventional
Sponsor
Genmab
ClinicalTrials.gov identifier
NCT04628494
Study number
GCT3013-05
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