Overview

A Phase 3 Trial of Epcoritamab in R/R DLBCL

Status:
Recruiting

Trial end date:
2024-05-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Genmab

Collaborator:

AbbVie

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
since lymphoma diagnosis

2. One of the confirmed histologies below with CD20-positivity:

1. DLBCL, NOS, including de novo or histologically transformed from FL

2. "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

3. FL 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

7. Life expectancy >2 months on SOC treatment

Main Exclusion Criteria:

1. Primary 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. ASCT within 100 days of randomization

7. Treatment with CAR-T therapy within 100 days prior to randomization

8. Seizure disorder requiring anti-epileptic therapy

9. Clinically significant cardiac disease,