Abbvie M23-362 Lymphoma

Full Name

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 Follicular Lymphoma

Description

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). 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) or R/R follicular lymphoma (FL). Adverse events will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R FL. 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 80 adult participants with R/R DLBCL and R/R FL will be enrolled in the study in approximately 40 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.

Eligibility

Inclusion Criteria

Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Follicular Lymphoma (FL) grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008 based on representative pathology report:
- 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 2 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy.
Must have 1 or more measurable disease sites:
- Fluorodeoxyglucose (FDG)-avid lymphomas: Measurable disease with computerized tomography (CT) (or magnetic resonance imaging [MRI]) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm (or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis >= 1.0 cm) AND FDG positron emission tomography (PET) scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.
- FDG-non avid lymphomas: Measurable disease with CT (or MRI) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis >= 1.0 cm.
Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Adequate organ function.