Epcoritamab + Ibrutinib for Central Nervous System Lymphoma

Recruiting at 7 trial locations

Overseen By Lauren Schaff, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antineoplastic agents, Warfarin, CYP3A inhibitors

Disqualifiers: Hepatic impairment, Active malignancy, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two treatments: epcoritamab (an immunotherapy) and ibrutinib (a targeted therapy). The goal is to determine their safety and whether they cause only mild side effects in people with certain types of brain lymphoma. The trial targets individuals with primary or secondary central nervous system lymphoma that has recurred or resisted previous treatment. Those managing these specific types of lymphoma and able to undergo MRI or CT scans might be suitable candidates for this study. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new combination therapy.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting, such as warfarin and drugs that affect the liver enzyme CYP3A. You must also avoid grapefruit and certain fruits. It's best to discuss your current medications with the trial team to see if any need to be stopped.

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

Previous studies have examined the safety of using epcoritamab and ibrutinib together. The findings suggest that this combination might be safe and tolerable for people with central nervous system lymphoma, as most participants did not experience severe side effects.

Ibrutinib has already received FDA approval for other conditions, so doctors are familiar with its safety profile. Epcoritamab remains under study, but early results indicate its safe use with ibrutinib. However, as this is an early-phase trial, much remains to be learned about how well people tolerate this combination. The main goal is to ensure that any side effects are mild and manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Epcoritamab and Ibrutinib for treating relapsed or refractory primary central nervous system lymphoma (PCNSL) because these drugs offer a novel approach. Unlike traditional chemotherapy and radiation treatments, Epcoritamab is a bispecific antibody that targets CD3 and CD20 proteins on cancer cells, potentially enhancing the immune system's ability to attack the lymphoma. Meanwhile, Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor, which interferes with signals that promote cancer cell survival. This dual-action method provides a targeted approach that might improve effectiveness and reduce side effects compared to conventional therapies.

What evidence suggests that this trial's treatments could be effective for central nervous system lymphoma?

Research has shown that ibrutinib can help treat central nervous system lymphoma. One study found that 21% of patients had a complete response, with no signs of cancer, and 29% had a partial response, with the cancer shrinking. Patients experienced about 6 months of progression-free survival. In this trial, researchers are testing a combination of ibrutinib and another drug, epcoritamab, to determine if it can improve these results. This combination is under study for safety and effectiveness, aiming to offer a stronger treatment for those whose cancer has returned or not responded to previous treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Christian Grommes, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with relapsed/refractory primary or secondary central nervous system lymphoma. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have a confirmed diagnosis of CNSL.

Inclusion Criteria

My bilirubin levels are within the required range.

I am able to get out of my bed or chair and move around.

My platelet count is above 75 x 10^9/L without transfusions in the last 3 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive epcoritamab in combination with ibrutinib to assess safety and tolerability

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Epcoritamab
• Ibrutinib

Trial Overview The study is testing the safety and side effect profile of combining two drugs, epcoritamab and ibrutinib, in treating central nervous system lymphoma. The goal is to determine if this combination therapy offers a beneficial treatment approach.

How Is the Trial Designed?

Group I: Cohort B2 Experimental Treatment 2 Interventions

Relapsed or refractory PCNSL (n=10)

Group II: Cohort B1 Experimental Treatment 2 Interventions

Relapsed or refractory PCNSL (n=10)

Group III: Cohort A Experimental Treatment 2 Interventions

Relapsed or refractory PCNSL (n=6)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07082868

NCT07082868 | A Study of Epcoritamab and Ibrutinib in ... The purpose of this study is to find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few or mild side ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-06902

A Study of Epcoritamab and Ibrutinib in People ... Giving epcoritamab and ibrutinib may be safe, tolerable and/or effective in treating patients with relapsed or refractory primary or secondary central nervous ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07082868/a-study-of-epcoritamab-and-ibrutinib-in-people-with-central-nervous-system-lymphoma-cnsl

A Study of Epcoritamab and Ibrutinib in People With ... The purpose of this study is to find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few ...

4. mskcc.org mskcc.org/cancer-care/clinical-trials/25-032

A Phase 1b Study of Epcoritamab and Ibrutinib Given ... ... combination of epcoritamab and ibrutinib is a safe treatment for people with central nervous system lymphoma (CNSL) that keeps growing or came back after

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8788490/

Ibrutinib in Refractory or Relapsing Primary Central Nervous ... Complete Response (CR) was observed in 21% (3/14) and Partial Response (PR) in 29% (4/14), and the median Progression-Free Survival (PFS) was 6 ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-05519

Epcoritamab plus Ibrutinib for the Treatment of Relapsed or ... This phase Ib/II trial tests the safety, side effects, and best dose of epcoritamab with ibrutinib in treating patients with aggressive B-cell non-Hodgkin ...