What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, particularly those similar to the combinations studied with Epcoritamab, often involve significant side effects. Lenalidomide can cause fatigue, diarrhea, and low blood counts. Ibrutinib is associated with diarrhea, bleeding, and heart issues. Polatuzumab vedotin and rituximab can lead to infusion reactions, low blood counts, and infections. Cyclophosphamide and doxorubicin may cause nausea, hair loss, and low blood counts. Prednisone can result in increased blood sugar, mood changes, and weight gain. Venetoclax is known for causing low blood counts and gastrointestinal issues. These treatments require careful monitoring due to their potential for severe adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma (NHL) that are similar to Epcoritamab, a bispecific antibody targeting CD3 and CD20. Rituximab, a monoclonal antibody targeting CD20, has been widely used in combination with chemotherapy for various types of NHL, including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Obinutuzumab, another anti-CD20 monoclonal antibody, has also been approved for FL. Additionally, Polatuzumab vedotin, an antibody-drug conjugate targeting CD79b, is approved in combination with bendamustine and rituximab for relapsed or refractory DLBCL. These treatments highlight the ongoing development and approval of targeted therapies for NHL.

What other types of research exist?

Promising novel alternatives to Epcoritamab for Non-Hodgkin's Lymphoma patients include: 1) CAR T-cell therapies such as Axicabtagene Ciloleucel and Tisagenlecleucel, which have shown significant efficacy in relapsed/refractory NHL. 2) Bispecific antibodies like Mosunetuzumab, targeting CD20 and CD3, which are in advanced stages of clinical trials. 3) Antibody-drug conjugates such as Polatuzumab Vedotin, which targets CD79b and has been approved for use in combination therapies. 4) Small molecule inhibitors like Ibrutinib and Venetoclax, which target BTK and BCL-2 respectively, and are used in various combinations for different subtypes of NHL.

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Protein Kinase Inhibitor

Epcoritamab Combo for Non-Hodgkin's Lymphoma

Phase 2

Recruiting

Research Sponsored by Genmab

Eligibility Criteria Checklist

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

Must have

DLBCL, not otherwise specified (NOS).

Diagnosis of Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:

Must not have

Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called epcoritamab, given with other cancer drugs, to treat adults with Non-Hodgkin lymphoma. The study aims to see if this combination is safe and effective. Participants will have periodic health evaluations to monitor their health and the treatment's impact.

Who is the study for?

Adults with Non-Hodgkin lymphoma (NHL) including various subtypes like diffuse large B-cell lymphoma and mantle cell lymphoma. Participants must have a certain level of physical fitness, measurable disease sites, and no unresolved toxicities from previous cancer therapies above a mild grade, except for hair loss.

What is being tested?

The trial is testing the safety and effectiveness of Epcoritamab when combined with other anti-cancer drugs in treating NHL. Patients are grouped to receive different combinations based on their specific type of NHL, either as new patients or those who've relapsed after prior treatments.

What are the potential side effects?

Potential side effects include reactions at the injection site due to Epcoritamab being given under the skin, plus typical chemotherapy-related effects such as nausea, fatigue, blood disorders, increased infection risk and possible organ inflammation.

Eligibility Criteria

Inclusion Criteria

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

Select...

My condition is diagnosed as DLBCL, not otherwise specified.

Select...

I have been diagnosed with a specific type of lymphoma (DLBCL) that tests positive for CD20.

Select...

My condition is Grade 3B Follicular Lymphoma.

Select...

My lymphoma is classified as 'double-hit' or 'triple-hit' according to WHO 2016.

Select...

My follicular lymphoma is CD20+ Grade 1-3a without turning aggressive.

Select...

I have a tumor that can be measured on a scan.

Select...

My lymphoma is CD20+ and shows specific genetic features.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not been treated with epcoritamab or similar drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Dose-Limiting Toxicities (DLT)

Secondary study objectives

Best Overall Response (BOR) per Investigator

Duration of response (DOR) per Investigator

Number of Participants with Progression-free survival (PFS)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

17Treatment groups

Experimental Treatment

Group I: Arm 8: Dose ExpansionExperimental Treatment2 Interventions

Participants with R/R MCL will receive the recommended dose of SC epcoritamab in combination with oral pirtobrutinib in 28 day cycles in the first year and then 56 day cycles thereafter.

Group II: Arm 8: Dose EscalationExperimental Treatment2 Interventions

Participants with R/R MCL will receive escalating doses of SC epcoritamab in combination with oral pirtobrutinib in 28 day cycles in the first year and then 56 day cycles thereafter.

Group III: Arm 7: Dose ExpansionExperimental Treatment3 Interventions

Participants with newly diagnosed treatment-naïve MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.

Group IV: Arm 7: Dose EscalationExperimental Treatment3 Interventions

Participants with newly diagnosed treatment-naïve MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.

Group V: Arm 6B: Dose EscalationExperimental Treatment3 Interventions

Participants with R/R MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.

Group VI: Arm 6A: Dose EscalationExperimental Treatment2 Interventions

Participants with R/R mantle cell lymphoma (MCL) will receive escalating doses of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.

Group VII: Arm 6: Dose ExpansionExperimental Treatment2 Interventions

Participants with R/R MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.

Group VIII: Arm 5: Dose ExpansionExperimental Treatment2 Interventions

Participants with R/R FL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.

Group IX: Arm 5: Dose EscalationExperimental Treatment2 Interventions

Participants with R/R follicular lymphoma (FL) will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.

Group X: Arm 4: Dose ExpansionExperimental Treatment2 Interventions

Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.

Group XI: Arm 4: Dose EscalationExperimental Treatment2 Interventions

Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.

Group XII: Arm 3: Dose ExpansionExperimental Treatment6 Interventions

Participants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.

Group XIII: Arm 3: Dose EscalationExperimental Treatment6 Interventions

Participants with newly diagnosed treatment-naïve DLBCL will receive escalating doses of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.

Group XIV: Arm 2: Dose ExpansionExperimental Treatment3 Interventions

Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.

Group XV: Arm 2: Dose EscalationExperimental Treatment3 Interventions

Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.

Group XVI: Arm 1: Dose ExpansionExperimental Treatment2 Interventions

Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral lenalidomide in 28 day cycles.

Group XVII: Arm 1: Dose EscalationExperimental Treatment2 Interventions

Participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will receive escalating doses of subcutaneous (SC) epcoritamab in combination with oral lenalidomide in 28 day cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pirtobrutinib

2020

Completed Phase 1

~240

Rituximab

1999

Completed Phase 4

~2990

Venetoclax

2019

Completed Phase 3

~2240

Ibrutinib

2014

Completed Phase 4

~2060

Lenalidomide

2005

Completed Phase 3

~2240

Cyclophosphamide

2010

Completed Phase 4

~2310

CC-99282

2020

Completed Phase 2

~80

Polatuzumab Vedotin

2019

Completed Phase 2

~820

Prednisone

2014

Completed Phase 4

~2500

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Non-Hodgkin's Lymphoma (NHL) treatments often target specific proteins on the surface of cancer cells to enhance the immune system's ability to destroy them. Epcoritamab, a bispecific antibody, binds to CD3 on T-cells and CD20 on B-cells, bringing them into close proximity to facilitate the T-cells' attack on the cancerous B-cells. Monoclonal antibodies like rituximab also target CD20, marking the cancer cells for destruction by the immune system. Small molecule inhibitors, such as ibrutinib, block signaling pathways essential for cancer cell survival and proliferation. Chemotherapy agents, like cyclophosphamide and doxorubicin, kill rapidly dividing cells, including cancer cells. These treatments are crucial for NHL patients as they offer targeted and effective ways to manage and potentially eradicate the disease, improving survival rates and quality of life.