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PD-1 Inhibitor

Pembrolizumab + Radiation Therapy for Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Alison Moskowitz, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Renal criteria: Creatinine OR Measured or calculated creatinine clearance CrCl (GFR can also be used in place of creatinine) ≤1.5 X upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN

Patients with early stage disease at diagnosis (stage I-II) who were treated with combined modality therapy (chemotherapy and radiation) who relapse with early stage disease (stage RI-II) outside the prior radiation therapy field

Must not have

Received >1 line of therapy for Hodgkin lymphoma

Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of pembrolizumab followed by radiation therapy in people with Hodgkin lymphoma.

Who is the study for?

This trial is for adults over 18 with early stage classical Hodgkin lymphoma that has either come back or didn't respond to initial treatment. They should have had only one prior therapy, be in good health with proper organ function, and not have active infections like HIV or hepatitis. Women of childbearing age must test negative for pregnancy and agree to contraception.

What is being tested?

The study tests pembrolizumab (a drug that helps the immune system fight cancer) followed by involved site radiation therapy (targeted radiation). It aims to see if this combo can cure relapsed/refractory Hodgkin lymphoma without the side effects of extensive chemotherapy or stem cell transplant.

What are the potential side effects?

Pembrolizumab may cause immune-related reactions affecting various organs, fatigue, infusion reactions similar to allergic responses, skin rash, diarrhea, and liver inflammation. Radiation might lead to localized skin redness and irritation at the treatment site.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function, measured by creatinine or GFR, is within the required range.

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My early stage cancer returned outside the area treated with radiation.

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My Hodgkin Lymphoma has come back or didn't respond to initial treatment.

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My liver function tests are within the required limits.

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I am using two birth control methods or am not able to have children, and will continue for 120 days after the study.

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I am 18 years old or older.

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My cancer was early stage at diagnosis and relapsed as early stage after chemotherapy.

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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 received more than one treatment for Hodgkin lymphoma.

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I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.

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I haven't had monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.

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I have been treated with a specific type of immune therapy before.

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My cancer was advanced (stage III or IV) when diagnosed or at its return.

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My cancer was larger than 10cm when first found or at its worst.

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I have symptoms like fever, weight loss, or night sweats.

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My cancer has returned or didn't respond to treatment in an area previously treated with radiation.

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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 treated with steroids, or I currently have lung disease.

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I am currently on IV antibiotics for an infection.

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I have been diagnosed with HIV, HBV, or HCV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Treatment Details

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: Pembrolizumab and Involved Site Radiation TherapyExperimental Treatment2 Interventions

Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 20Eligibility criteria met