Clinical Trials /

A Phase 3 Trial of Epcoritamab in R/R DLBCL

NCT04628494

Description:

This is an open-label, randomized (1:1), multi-center trial of epcoritamab (GEN3013; DuoBody®-CD3xCD20) versus prespecified investigator's choice of chemotherapy in patients with relapsed, refractory diffuse large B-Cell Lymphoma

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Grade 3b Follicular Lymphoma
  • High Grade B-Cell Lymphoma with MYC and BCL2 and/or BCL6 Rearrangements
  • Richter Syndrome
  • Transformed Non-Hodgkin Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Phase 3 Trial of Epcoritamab in R/R DLBCL
  • Official Title: A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: GCT3013-05
  • NCT ID: NCT04628494

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

DrugSynonymsArms
EpcoritamabGEN3013; DuoBody®-CD3xCD20Epcoritamab (GEN3013; DuoBody®CD3xCD20)
Investigator's Choice ChemotherapyBR or R-GemOxInvestigator's choice of chemotherapy

Purpose

This is an open-label, randomized (1:1), multi-center trial of epcoritamab (GEN3013; DuoBody®-CD3xCD20) versus prespecified investigator's choice of chemotherapy in patients with relapsed, refractory diffuse large B-Cell Lymphoma

Detailed Description

      The purpose of this trial is to evaluate the efficacy of epcoritamab (GEN3013
      DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy in patients with
      relapsed, refractory diffuse large B-Cell Lymphoma who have failed or are ineligible for
      HDT-ASCT.

      Eligible patients will be randomized (1:1) to either epcoritamab or investigator's choice of
      chemotherapy: R-GemOx (rituximab, bendamustine and oxaliplatin) or BR (bendamustine and
      rituximab).
    

Trial Arms

NameTypeDescriptionInterventions
Epcoritamab (GEN3013; DuoBody®CD3xCD20)ExperimentalEpcoritamab will be administered in Cycles of 28 days until disease progression
  • Epcoritamab
Investigator's choice of chemotherapyActive ComparatorR-GemOx will be administrated in Cycles of 28 days. BR will be administrated in Cycles of 21 days.
  • Investigator's Choice Chemotherapy

Eligibility Criteria

        Main Inclusion Criteria:

          1. Relapsed or refractory disease and previously treated with at least 1 line of systemic
             antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy

          2. Histologically confirmed CD20+ DLBCL including:

               1. De novo or histologically transformed (including Richter's transformation)

               2. "double-hit" or "triple-hit" (technically classified in WHO 2016 as high-grade
                  B-cell lymphoma (HGBCL, with MYC and BCL2 and/or BCL6 translocations)

               3. Follicular lymphoma Grade 3B

          3. ECOG PS score of 0-2

          4. Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening

          5. Patients must have detectable disease by PET scan and measurable by CT scan or MRI

          6. Acceptable renal and liver function

        Main Exclusion Criteria:

          1. Primary CNS tumor or known CNS involvement

          2. Any prior therapy with a bispecific antibody targeting CD3 and CD20

          3. Radiation therapy, or major surgery within 4 weeks prior to randomization

          4. Chemotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to
             randomization

          5. Non-investigational antineoplastic agents or any investigational drug within 4 weeks
             or 5 half-lives, whichever is longer, prior to randomization

          6. ASCT within 100 days of randomization

          7. Treatment with CAR-T therapy within 30 days prior randomization

          8. Seizure disorder requiring anti-epileptic therapy

          9. Clinically significant cardiac disease,
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Compare the clinical efficacy of epcoritamab to standard of care (SOC) - Overall Survival (OS)
Time Frame:throughout the study and up to 2 years following the last patient first dose
Safety Issue:
Description:OS is calculated as the time from first dose to death date or last date known to be alive.

Secondary Outcome Measures

Measure:Compare other measures of epcoritamab efficacy to SOC - Progression Free Survival (PFS)
Time Frame:throughout the study and up to 2 years following the last patient first dose
Safety Issue:
Description:PFS is calculated as the time from randomization to the date of disease progression or death, whichever is earlier. Progression is determined by the Lugano criteria and LYRIC.
Measure:Compare other measures of epcoritamab efficacy to SOC - Overall Response Rate (ORR)
Time Frame:throughout the study and up to 2 years following the last patient first dose
Safety Issue:
Description:ORR is calculated as the proportion of subjects achieving a complete response or partial response. Response is determined by the Lugano criteria and LYRIC.
Measure:Compare other measures of epcoritamab efficacy to SOC - Complete Response (CR)
Time Frame:throughout the study and up to 2 years following the last patient first dose
Safety Issue:
Description:CR rate is calculated as the proportion of subjects achieving a complete response. Response is determined by the Lugano criteria and LYRIC.
Measure:Compare other measures of epcoritamab efficacy to SOC - Duration of Response (DOR)
Time Frame:throughout the study and up to 2 years following the last patient first dose
Safety Issue:
Description:DOR is calculated as the time from initial response (CR or PR) to date of progression or death, whichever is earlier. Response and progression are determined by the Lugano criteria and LYRIC.
Measure:Compare other measures of epcoritamab efficacy to SOC - Time to Response (TTR)
Time Frame:throughout the study and up to 2 years following the last patient first dose
Safety Issue:
Description:TTR is calculated as the time from randomization to date of initial response (CR or PR) among responders only. Response is determined by the Lugano criteria and LYRIC.
Measure:Compare other measures of epcoritamab efficacy to SOC - Time to next anti-lymphoma therapy (TTNT)
Time Frame:throughout the study and up to 2 years following the last patient first dose
Safety Issue:
Description:TTNT is calculated as the time from randomization to date of initiation of new anti-lymphoma therapy.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Genmab

Trial Keywords

  • double-hit DLBCL
  • triple-hit DLBCL
  • follicular grade 3B
  • transformed DLBCL
  • Richters transformation

Last Updated

November 16, 2020