A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

Study Identifier
GCT3013-05
CT.gov Identifier
NCT04628494
EudraCT Identifier
2020-003016-27
EUCTIS ID
2023-504830-23-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Blood Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
    • Study Drug
  • Epcoritamab
  • Investigator's Choice Chemotherapy
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Main Inclusion Criteria: 1. 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 2. One of the confirmed histologies below with CD20-positivity: 1. DLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL) 2. "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 3. FL Grade 3B 4. T-cell/histiocyte-rich large B-cell lymphoma 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2 4. Failed previous HDT-ASCT or not eligible for high-dose therapy autologous stem cell transplant (HDT-ASCT) at screening 5. Participants must have detectable disease by positron emission tomography (PET) scan and measurable by computed tomography (CT) scan or magnetic resonance imaging (MRI) 6. Acceptable renal and liver function 7. Life expectancy \>2 months on standard of care treatment Main Exclusion Criteria: 1. Primary Central Nervous System (CNS) tumor or known CNS involvement 2. Any prior therapy with a bispecific antibody targeting CD3 and CD20 3. Major surgery within 4 weeks prior to randomization 4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization 5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization 6. Autologous stem cell transplant (ASCT) within 100 days of randomization 7. Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to randomization 8. Seizure disorder requiring anti-epileptic therapy 9. Clinically significant cardiac disease

    Protocol Summary

    The purpose of this trial is to find out if epcoritamab, also known as EPKINLY™ 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.

    Study Locations

    Location
    Status
    Location
    Indiana Blood and Marrow Transplantation
    Indianapolis, Indiana, United States, 46237
    Status
    Not applicable
    Location
    Community Health Network Cancer Center North
    Indianapolis, Indiana, United States, 46250
    Status
    Not applicable
    Location
    University of Kentucky Markey Cancer Center
    Lexington, Kentucky, United States, 40536
    Status
    Not applicable
    Location
    Henry Ford Health System
    Jackson, Michigan, United States, 49201
    Status
    Not applicable
    Location
    MMCORC Attn Delaney Anderson
    Saint Louis Park, Minnesota, United States, 55416
    Status
    Not applicable
    Location
    MD Anderson Cancer Center at Cooper
    Camden, New Jersey, United States, 08103
    Status
    Not applicable
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