Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

Study Identifier
GCT3013-02
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
2023-504805-35-00
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Study Details

Medical Condition
  • Blood Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
  • Blood Cancer - Follicular Lymphoma (FL)
  • Study Drug
  • rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
  • rituximab and lenalidomide
  • rituximab and bendamustine
  • rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
  • gemcitabine and oxaliplatin
  • Epcoritamab
  • rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
  • Lenalidomide
  • rituximab, ifosfamide, carboplatin, and etoposide phosphate
  • Rituximab and Lenalidomide
  • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating participants with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to identify the most appropriate dose of epcoritamab, and the aim of the second part of the trial is to assess the selected epcoritamab dose in a larger group of participants with B-NHL. All participants in this trial will receive either epcoritamab alone, or epcoritamab combined with another standard treatment regimen, with a total of 10 different treatment arms being studied.

    Trial details include:

    • The treatment duration for each participant depends upon which arm of treatment they are assigned to.
    • The visit frequency for each participant depends upon which arm of treatment they are assigned to, but will be weekly to start for all participants, then will decrease to either: every 2 weeks, or every 3 weeks, or every 4 weeks, or every 8 weeks.
    • All participants will receive active drug; no one will be given placebo.

    Participants who receive treatment with epcoritamab will have it injected right under the skin. Participants will receive a different regimen of epcoritamab depending upon which arm of treatment they are assigned.

    Participants who receive standard treatments will have intravenous (IV) infusions and/or oral administration of those treatments. Participants will receive a different standard treatment regimen depending upon which arm of treatment they are assigned.

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham
    Birmingham, Alabama, United States, 35294
    Status
    Not applicable
    Location
    Cedars-Sinai Medical Center
    Los Angeles, California, United States, 90048
    Status
    Not applicable
    Location
    David Geffen School of Medicine at UCLA
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    University of California San Francisco
    San Francisco, California, United States, 94143
    Status
    Not applicable
    Location
    Dana Farber Cancer Institute
    Boston, Massachusetts, United States, 02215
    Status
    Not applicable
    Location
    University of Michigan Comprehensive Cancer Center Michigan Medicine
    Ann Arbor, Michigan, United States, 48109
    Status
    Not applicable
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