A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R)… (NCT04628494) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
United States484 participantsStarted 2021-01-13
Plain-language summary
The purpose of this trial is to find out if epcoritamab, also known as EPKINLYâ„¢ and GEN3013, is safe and works well as treatment for participants with DLBCL that are not responding to treatment, have grown in size, or have come back following treatment with at least 1 prior systemic cancer therapy. All participants in this trial will be randomly assigned to receive either epcoritamab or a pre-specified investigator's choice (standard of care) chemotherapy (either rituximab + gemcitabine + oxaliplatin \[R-GemOx\], or bendamustine + rituximab \[BR\]). Participants must have failed or be ineligible to receive an autologous stem cell transplant (ASCT).
Epcoritamab will be injected under the skin. Investigator's choice chemotherapy will be given intravenously.
Trial details include:
* The trial duration will be up to 5 years after last participant is randomized.
* All trial participants have a 21-day screening period, a treatment period, and a follow-up period that continues until death.
* The estimated trial duration for an individual participant depends upon the treatment arm assigned:
* Participants who receive epcoritamab will have 28-day treatment cycles. Epcoritamab will be given once weekly for the first 3 months, then every other week for 6 months, then every 28 days until lymphoma progression or unacceptable adverse events.
* Participants who receive investigator's choice (standard of care) chemotherapy will receive treatments either:
* R-GemOx: On Day 1 (or Day 1 \& Day 2), and Day 15 (or Day 15 \& Day 16) every 28 days, for up to 4 months; or
* BR: On Day 1 and Day 2 every 3 weeks for up to 4.5 months.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 monoclonal antibody (mAb)-containing combination chemotherapy since lymphoma diagnosis
✓. One of the confirmed histologies below with CD20-positivity:
✓. DLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL)
✓. "Double-hit" or "triple-hit" DLBCL (technically classified in World Health Organization (WHO) 2016 as high-grade B-cell lymphoma (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
✓. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2
✓. Failed previous HDT-ASCT or not eligible for high-dose therapy autologous stem cell transplant (HDT-ASCT) at screening
. 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
✕. Autologous stem cell transplant (ASCT) within 100 days of randomization
✕. Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to randomization