Epcoritamab + EPOCH-R for Non-Hodgkin's Lymphoma

Overseen By Mengyang Di, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Washington

Must not be taking: Antiretrovirals, Methotrexate

Disqualifiers: Organ transplant, Peripheral neuropathy, Cardiovascular disease, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining epcoritamab with standard chemotherapy treatment (EPOCH-R) is safe and effective for individuals with aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is a specialized antibody that aids the immune system in targeting and killing cancer cells. Participants recently diagnosed with this type of lymphoma and with minimal prior treatment may be suitable for the study. The goal is to assess whether adding epcoritamab can enhance the treatment's effectiveness and improve cancer management. As a Phase 2 trial, the research focuses on measuring the treatment's efficacy in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to understand any potential interactions or requirements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining epcoritamab with EPOCH-R, a common chemotherapy treatment, is generally safe and manageable for treating aggressive B-cell non-Hodgkin lymphoma. In earlier studies, most patients experienced some side effects, but these were usually manageable. Fatigue and nausea were common, typical of cancer treatments.

Epcoritamab has been tested in other studies and was found to be well-tolerated. Most patients experienced mild to moderate side effects, with serious side effects being less common.

The safety of EPOCH-R is well-known, as it is a standard treatment. It has been widely used and is considered safe, although it can cause side effects like low blood counts or infections, similar to many cancer treatments.

Overall, research suggests that combining epcoritamab with EPOCH-R may be safe, but like any treatment, there are risks. Participants in trials help researchers improve the safety of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Epcoritamab for Non-Hodgkin's Lymphoma because it offers a novel approach compared to traditional treatments like R-CHOP therapy. Unlike these conventional treatments, Epcoritamab is a bispecific antibody that uniquely targets CD3 and CD20 proteins on cancer cells, enhancing the immune system's ability to attack lymphoma cells directly. Additionally, its subcutaneous administration allows for a more targeted delivery, potentially reducing side effects and improving patient comfort. This innovative mechanism and delivery method could lead to more effective and tolerable treatment options for patients.

What evidence suggests that this trial's treatments could be effective for aggressive B-cell non-Hodgkin lymphoma?

This trial will evaluate the combination of Epcoritamab with EPOCH-R for treating aggressive B-cell non-Hodgkin lymphoma. Studies have shown that Epcoritamab, which participants in this trial will receive, yields promising results, with about 83% of patients who had a complete response remaining cancer-free for two years. EPOCH-R, which includes drugs like rituximab and cyclophosphamide, has demonstrated a 68% overall response rate, with 45% of patients experiencing complete or nearly complete disappearance of cancer. The combination aims to leverage Epcoritamab's ability to connect T-cells and cancer cells to enhance the immune system's response. These findings suggest that adding Epcoritamab to EPOCH-R could improve outcomes for patients with this type of lymphoma. ^{1 3 4 6 7}

Who Is on the Research Team?

Mengyang Di, MD, PhD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for patients with aggressive B-cell non-Hodgkin lymphoma. Participants should be suitable for the EPOCH-R chemotherapy regimen and willing to undergo various tests like echocardiography, PET scans, CT scans, and bone marrow procedures. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)

Platelets ≥ 75,000 / mcL except in cases of marrow infiltration by lymphoma or hypersplenism

I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

I have had an organ transplant.

Positive test results for hepatitis C

History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive rituximab, prednisone, etoposide, doxorubicin, cyclophosphamide, and epcoritamab over 6 cycles of 21 days each

18 weeks

Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Periodic visits

What Are the Treatments Tested in This Trial?

Interventions

• Cyclophosphamide
• Doxorubicin
• Epcoritamab
• Etoposide
• Prednisone
• Rituximab

Trial Overview The trial is testing epcoritamab combined with a chemo cocktail (EPOCH-R) against aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is an antibody that targets cancer cell antigens CD3/CD20 to hinder their growth.

How Is the Trial Designed?

Group I: Treatment (Epcoritamab and EPOCH-R) Experimental Treatment 14 Interventions

Patients receive rituximab IV on day 1, prednisone PO BID on days 1-5, etoposide IV and doxorubicin on days 1-4 and cyclophosphamide IV on day 5 of each cycle. Patients also receive epcoritamab SC on days 8 and 15 of cycle 1, days 1, 8 and 15 of cycles 2-4 and day 1 of cycles 5-6. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MUGA scan or echocardiography during screening and receive fludeoxyglucose and undergo PET scan, CT scan, bone marrow biopsy and aspirate (if needed), and blood sample collection throughout the study.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07097363

Study Details | NCT07097363 | Epcoritamab With Dose ... Giving epcoritamab with EPOCH-R may be safe, tolerable, and effective in treating patients with aggressive B-cell non-Hodgkin lymphoma. Detailed Description.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12589155/

Efficacy and Safety of Rituximab plus Modified EPOCH ... The overall response rate was 68%, with 45% achieving complete response (CR) or unconfirmed CR and 23% achieving partial response. With a median ...

3. haematologica.org haematologica.org/article/view/12964/79021

Outcomes of patients with relapsed or refractory primary ... After frontline treatment with DA-EPOCH-R, 62% of patients included in this analysis did not achieve a CR.

4. news.abbvie.com news.abbvie.com/2024-12-09-Two-Data-Analyses-From-Clinical-Trials-Show-Epcoritamab-DuoBody-R-CD3xCD20-Induces-Durable-Complete-Reponses-As-Monotherapy-and-Combination-Treatment-in-Patients-With-Diffuse-Large-B-Cell-Lymphoma

Two Data Analyses From Clinical Trials Show Epcoritamab ... Among complete responders, an estimated 83% remained in remission after two years. Separately, three-year follow-up results from the Phase 2 ...

5. onclive.com onclive.com/view/epcoritamab-plus-r-ice-yields-high-cr-rates-and-improves-transplant-eligibility-in-r-r-dlbcl

Epcoritamab Plus R-ICE Yields High CR Rates and ... Epcoritamab combined with R-ICE therapy achieved high response rates in relapsed/refractory DLBCL patients eligible for ASCT, with an 87% ORR ...

6. ashpublications.org ashpublications.org/blood/article/146/18/2177/546196/Real-world-outcomes-of-patients-with-aggressive-B

Real-world outcomes of patients with aggressive B-cell ... A total of 201 of 245 patients (82.0%) were efficacy-evaluable (124 treated with epcoritamab [80%], and 77 treated with glofitamab [87%]).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11588654/

Epcoritamab in relapsed/refractory large B-cell lymphoma We report long-term efficacy and safety results in patients with LBCL (N = 157; 25.1-month median follow-up). As of April 21, 2023, overall ...