A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma

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Genmab

Status and phase

Enrolling
Phase 2

Conditions

Classic Follicular Lymphoma
Diffuse Large B-Cell Lymphoma

Treatments

Drug: Epcoritamab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05451810
M23-362

Details and patient eligibility

About

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic follicular lymphoma (cFL). Adverse events will be assessed. Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R cFL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 184 adult participants with R/R DLBCL and R/R cFL will be enrolled in the study in approximately 80 sites in the United States of America. Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Enrollment

184 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Classic Follicular Lymphoma (cFL), with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008 based on representative and most recent pathology report:

  • Can include participants with "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Other double-/triple-hit lymphomas are not eligible.
  • Relapsed or refractory disease and previously treated with at least 1 prior systemic anti-lymphoma therapy for DLBCL and 2 prior systemic antineoplastic therapies for cFL including at least 1 anti-CD20 monoclonal antibody-containing therapy

Has at least one target lesion defined as:

  • ≥ 1 measurable nodal lesion (long axis > 1.5 cm and short axis > 1.0 cm) and/or ≥ 1 measurable extranodal lesion (long axis > 1.0 cm) on CT (or MRI) AND
  • FDG PET scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.
  • Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
  • Adequate organ function.

Exclusion criteria

  • Central nervous system (CNS) involvement by lymphoma.
  • Uncontrolled Human Immunodeficiency Virus (HIV) infection. HIV viral load that is undetectable and controlled with medication for at least 1 year prior to enrollment is allowed. Note: If subject has no history of HIV infection, HIV testing does not need to be conducted at screening unless it is required per local guidelines or institutional standards.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

184 participants in 4 patient groups

Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL)
Experimental group
Description:
Participants with relapsed or refractory (R/R) DLBCL will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Treatment:
Drug: Epcoritamab
Main Cohort: Epcoritamab Classic Follicular Lymphoma (cFL)
Experimental group
Description:
Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.
Treatment:
Drug: Epcoritamab
Diversity Enriched Cohort: Epcoritamab DLBCL
Experimental group
Description:
Participants with R/R DLBCL will receive SC epcoritamab in 28 day cycles.
Treatment:
Drug: Epcoritamab
Diversity Enriched Cohort: Epcoritamab cFL
Experimental group
Description:
Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.
Treatment:
Drug: Epcoritamab

Trial contacts and locations

51

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Central trial contact

ABBVIE CALL CENTER

Data sourced from clinicaltrials.gov

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