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A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) When Administered in the Outpatient Setting


Description

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 o

Trial Eligibility

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.

Study Info

Organization

Genmab


Primary Outcome

Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events


Outcome Timeframe Up to 3 Months

NCTID NCT05451810

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2022-08-17

Completion Date 2027-08-29

Enrollment Target 184

Interventions

DRUG Epcoritamab

Locations Recruiting

Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630

United States, Alabama, Mobile


University of Arkansas for Medical Sciences /ID# 244562

United States, Arkansas, Little Rock


Highlands Oncology Group, PA /ID# 245002

United States, Arkansas, Springdale


Beverly Hills Cancer Center /ID# 255327

United States, California, Beverly Hills


Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133

United States, California, Fountain Valley


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