Print  |  Close

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


Active: Yes
Cancer Type: Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
NCT ID: NCT05451810
Trial Phases: Phase II Protocol IDs: M23-362 (primary)
NCI-2022-09111
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Genmab
NCI Full Details: http://clinicaltrials.gov/show/NCT05451810

Summary

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.