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Checkpoint Inhibitor

Pembrolizumab + Radiation Therapy for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Chelsea C Pinnix

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Have pathologic confirmation of aggressive non-Hodgkin lymphoma (including specific subtypes)

Have at least one site of lymphomatous disease amenable to external beam radiation therapy (EBRT)

Must not have

Has a history of allogeneic stem cell transplantation

Has a diagnosis of specific autoimmune diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing pembrolizumab with radiation therapy to see if it is more effective than pembrolizumab alone in treating patients with non-Hodgkin lymphoma that has returned or does not respond to treatment.

Who is the study for?

This trial is for patients with relapsed or refractory non-Hodgkin lymphoma who can undergo radiation therapy, have measurable disease, and are in good health otherwise. They must not be pregnant, agree to use contraception, and cannot have had certain recent treatments or active infections like TB or hepatitis.

What is being tested?

The study is testing the combination of pembrolizumab (an immunotherapy drug) with external beam radiation therapy to see if it's more effective than pembrolizumab alone for treating non-Hodgkin lymphoma that has returned after treatment or hasn't responded to previous therapies.

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects such as inflammation in various organs, skin reactions, hormonal gland problems (like thyroid), infusion reactions; fatigue; liver issues; and possibly complications from combining with radiation.

Eligibility Criteria

Inclusion Criteria

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

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My lymphoma is confirmed to be an aggressive type.

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I have a lymphoma site that can be treated with radiation.

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I have provided a sample of my tumor that has not been treated with radiation.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have had a stem cell transplant from a donor.

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I have been diagnosed with a specific autoimmune disease.

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I have an immune system disorder or am taking steroid medication.

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I have active cancer in my brain or spinal cord.

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I have been treated for an autoimmune disease in the last 2 years.

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I have had lung inflammation or disease not caused by an infection.

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I have had radiation therapy on the area that may be targeted again.

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I have an active TB infection.

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I have received a cancer treatment drug from the monoclonal antibody group within the last 4 weeks.

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I have not had chemotherapy, targeted therapy, or radiation in the last 2 weeks.

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I have been treated with specific medications before.

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I have not received a live vaccine in the last 30 days.

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I am currently being treated for an infection.

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I have a history of HIV or active hepatitis B or C.

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

Overall response rate of an unirradiated lesion to pembrolizumab with external beam radiation therapy

Secondary study objectives

Complete response rate

Overall survival

Progression free survival

Awards & Highlights

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (EBRT, pembrolizumab)Experimental Treatment2 Interventions

Beginning on day 1, patients undergo fractionated EBRT daily for 5 consecutive days a week for up to 12 or 22 treatments. Patients also receive pembrolizumab IV over 1 hour on day 2. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

External Beam Radiation Therapy

2006

Completed Phase 3

~3300

0 / 18Eligibility criteria met