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Monoclonal Antibodies

Epcoritamab + Tazemetostat for Follicular Lymphoma

Phase 2

Waitlist Available

Led By Swetha Kambhampati

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Age: ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) ≤ 2

Must not have

Prior bispecific antibodies or tazemetostat

Immunosuppressive agents other than prednisolone 20 mg daily or equivalent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a combination of two drugs, epcoritamab and tazemetostat, to see if they are safe and effective in treating patients with a specific type of lymph

Who is the study for?

This trial is for patients with grade I-IIIa follicular lymphoma that has either returned after treatment or hasn't responded to past treatments. Specific eligibility details are not provided, but typically participants must meet certain health standards and have a confirmed diagnosis.

What is being tested?

The trial is testing the combination of epcoritamab, a bispecific antibody targeting cancer cell antigens, and tazemetostat, an enzyme inhibitor aimed at stopping cancer growth. This phase II study evaluates their safety and effectiveness in treating relapsed or refractory lymphoma.

What are the potential side effects?

Potential side effects may include immune system reactions due to epcoritamab's action on cancer cells and possible impacts on normal cell growth from tazemetostat's enzyme inhibition. The exact side effects are being studied.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I can perform daily activities with minimal assistance.

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My lymphoma has returned or didn't respond after my first treatment.

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My blood clotting levels are within normal limits without taking blood thinners.

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My blood clotting time is within normal limits and I'm not on blood thinners.

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My kidneys are functioning well, with a creatinine clearance of 45 mL/min or more.

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I have a lymph node or tumor larger than 1.5 cm visible on a scan.

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My lymphoma is confirmed as follicular grades 1-3A.

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I have recovered from side effects of cancer treatment, except for hair loss.

Exclusion Criteria

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

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I have not taken bispecific antibodies or tazemetostat before.

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I am not on immunosuppressive drugs, except for prednisolone or its equivalent up to 20 mg daily.

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I have not had major surgery in the last 4 weeks.

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I cannot take pills by mouth or have a condition that affects how my body absorbs food.

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I had a stem cell transplant using my own cells within the last 30 days.

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I had a stem cell transplant and am experiencing complications or taking immunosuppressants.

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I haven't had chemotherapy, radiation, or immunotherapy in the last 21 days.

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I have a serious heart condition that is currently causing symptoms.

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I have an active HIV, HCV, or HBV infection.

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I currently have an active COVID-19 infection.

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I do not have an uncontrolled infection.

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I have a history of certain blood cancers.

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I am not pregnant or breastfeeding.

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My lymphoma has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Complete response (CR) rate

Incidence of unacceptable adverse events (Safety lead-in)

Secondary study objectives

Duration of response (DOR)

Incidence of adverse events

Overall response rate (ORR)

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (epcoritamab, tazemetostat)Experimental Treatment6 Interventions

Patients receive tazemetostat PO BID on days 1-28 of each cycle. Patients also receive epcoritamab SC on days 1, 8, 15, and 22 of cycles 2-4 then on day 1 of remaining cycles. Cycles repeat every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples on study and undergo bone marrow biopsy and CT or PET/CT throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Tazemetostat

2016

Completed Phase 2

~1050