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Monoclonal Antibodies

Epcoritamab for Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-1 Trial)

Phase 3

Waitlist Available

Research Sponsored by Genmab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Life expectancy >2 months on SOC treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years after randomization of the last patient

Awards & highlights

EPCORE DLBCL-1 Trial Summary

This trial will investigate whether the drug epcoritamab is effective in treating people with diffuse large B cell lymphoma who have relapsed or are refractory to previous treatment.

Who is the study for?

This trial is for adults with certain types of B-cell lymphoma, including Diffuse Large B-Cell Lymphoma (DLBCL), who have not responded to or are ineligible for a stem cell transplant. Participants must be in relatively stable health and have measurable disease by scans. They cannot join if they've had recent major surgery, CAR-T therapy, seizures requiring medication, heart issues, CNS tumors or involvement, prior CD3/CD20 bispecific antibody treatment.Check my eligibility

What is being tested?

The study compares the effectiveness of Epcoritamab—an antibody drug—against standard chemotherapy chosen by the investigator. Patients will be randomly assigned to receive either Epcoritamab or chemotherapy to see which works better for relapsed/refractory DLBCL after previous treatments failed.See study design

What are the potential side effects?

While specific side effects for Epcoritamab aren't listed here, similar drugs can cause immune reactions, infusion-related symptoms like fever and chills, fatigue, liver and kidney function changes. Chemotherapy may lead to nausea/vomiting, hair loss, increased infection risk due to low blood counts.

EPCORE DLBCL-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma has returned or didn't respond to treatment, and I've had at least one treatment that included anti-CD20.

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My doctor expects me to live more than 2 months with standard treatment.

Select...

My lymphoma is CD20-positive and matches one of the specified types.

Select...

My cancer can be seen on a PET scan and measured by CT or MRI.

Select...

My kidney and liver are working well.

Select...

I can take care of myself and perform daily activities.

Select...

I either did not respond to high-dose chemotherapy with stem cell transplant or am not eligible for it.

EPCORE DLBCL-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years after randomization of the last patient

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years after randomization of the last patient

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years after randomization of the last patient for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Anti-epcoritamab antibody response

Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

Complete Response (CR)

+9 more

EPCORE DLBCL-1 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Epcoritamab (GEN3013; DuoBody®CD3xCD20)Experimental Treatment1 Intervention

Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met

Group II: Investigator's choice of chemotherapyActive Control1 Intervention

R-GemOx will be administrated in Cycles of 28 days until maximum cycles completion or any of the discontinuation criteria is met BR will be administrated in Cycles of 21 days until maximum cycles completion or any of the discontinuation criteria is met

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

GenmabLead Sponsor

56 Previous Clinical Trials

11,680 Total Patients Enrolled

AbbVieIndustry Sponsor

954 Previous Clinical Trials

500,492 Total Patients Enrolled

Media Library

Epcoritamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04628494 — Phase 3

Diffuse Large B-Cell Lymphoma Research Study Groups: Investigator's choice of chemotherapy, Epcoritamab (GEN3013; DuoBody®CD3xCD20)

Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Epcoritamab Highlights & Side Effects. Trial Name: NCT04628494 — Phase 3

Epcoritamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04628494 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the goal that we are hoping to achieve with this research?

"The primary focus of this clinical trial is Overall Survival, but data will also be collected on Incidence of dose interruptions and delays, Incidence and severity of changes in laboratory values, and Complete Response."

Answered by AI

What is the present standing of Epcoritamab in the eyes of the FDA?

"There is some evidence of efficacy and extensive safety data supporting Epcoritamab, and thus it received a score of 3."

Answered by AI

Is it possible to join this trial if you are currently ill?

"That is correct. The clinical trial, as advertised on clinicaltrials.gov, is currently seeking patients. The trial was first posted on 1/13/2021, with the most recent update on 9/15/2022. A total of 480 individuals are needed across 23 sites."

Answered by AI

Could you please tell me if Epcoritamab has been used in other medical research programs?

"Six different clinical trials are currently underway to investigate epcoritamab. One of those studies has reached phase 3. Most of the research thus far has been conducted in Maastricht and Michigan, but there are 497 sites running trials for this medication globally."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL

2021. "A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04628494.