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Monoclonal Antibodies

Pembrolizumab + Tazemetostat for Non-Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Reem Karmali, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Patients must have a histo-pathologically confirmed aggressive B-cell NHL intended for or currently undergoing standard of care ASCT or CAR T-cell therapy

Patients should have met the FDA approved indications for the respective CAR T cell construct being used

Must not have

Patients with active autoimmune disease that has required systemic treatment in the past 2 years

Patients with a diagnosis of immunodeficiency or receiving chronic systemic glucocorticoids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from asct or car t-cell infusion until death from any cause, up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how well pembrolizumab and tazemetostat work together to treat patients with aggressive non-Hodgkin's lymphoma who have previously undergone autologous

Who is the study for?

This trial is for patients with aggressive B-cell Non-Hodgkin's Lymphoma who have already undergone autologous stem cell transplantation (ASCT) or chimeric antigen receptor (CAR) T-cell therapy. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.

What is being tested?

The trial is testing the combination of pembrolizumab (a monoclonal antibody that helps the immune system detect and fight cancer cells) and tazemetostat (a drug that may stop cancer growth by blocking certain enzymes), to see if they can improve outcomes in patients post-ASCT or CAR-T therapy.

What are the potential side effects?

Potential side effects from pembrolizumab could include fatigue, skin reactions, diarrhea, liver inflammation, and infusion-related reactions. Tazemetostat might cause tiredness, nausea, loss of appetite or weight loss. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

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

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I have aggressive B-cell NHL and am getting a stem cell transplant or CAR T-cell therapy.

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I meet the FDA requirements for my specific CAR T cell therapy.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My PET/CT scan shows active cancer before starting CAR T-cell therapy.

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I am in complete remission and ready for stem cell transplant.

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My kidneys are functioning well enough, with a creatinine clearance of 30 mL/min or more.

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I have had hepatitis C but my viral load is now undetectable.

Exclusion Criteria

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

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I have an autoimmune disease treated with medication in the last 2 years.

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I have an immune system disorder or I'm on long-term steroids.

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I have a known history of HIV.

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I have had myeloid malignancies or T-cell lymphoblastic lymphoma before.

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

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I have not had radiotherapy in the last 14 days.

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I have previously been treated with EZH2 inhibitors or similar drugs.

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I have a history of chronic hepatitis B.

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I have or had lung inflammation that needed steroids.

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I have another cancer that is getting worse or I am currently being treated for.

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I am not pregnant or nursing.

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I have active brain metastases or carcinomatous meningitis.

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I have side effects from previous cancer treatments that affect my health.

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I have received an organ or tissue transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from asct or car t-cell infusion until death from any cause, up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from asct or car t-cell infusion until death from any cause, up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from asct or car t-cell infusion until death from any cause, 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

Event free survival

Secondary study objectives

Complete response rate

Incidence of adverse events

Objective response rate (ORR)

+3 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 (pembrolizumab, tazemetostat)Experimental Treatment6 Interventions

Starting on day 14 after standard of care ASCT or CAR-T cell treatment patients receive pembrolizumab IV on day 1 of each cycle. Starting cycle 2, patients receive tazemetostat PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography during screening, CT scan, PET scan, and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Biospecimen Collection

2004

Completed Phase 3

~2020