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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
complete response rate

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 2
~2010

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,839 Total Patients Enrolled
Alison Moskowitz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
10 Previous Clinical Trials
573 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03179917 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Pembrolizumab and Involved Site Radiation Therapy
Hodgkin's Lymphoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03179917 — Phase 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03179917 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts ongoing for this research project?

"Yes, this trial is currently looking for enrollees. The listing was originally posted on June 8th, 2017 and was most recently updated on July 1st, 2022."

Answered by AI

What other pembrolizumab studies have taken place in the past?

"City of Hope was the first institution to study pembrolizumab back in 2010 and, since then, there have been a total of 250 clinical trials completed. There are presently 1000 active studies being conducted with many taking place in Basking Ridge, New jersey."

Answered by AI

Is this experiment being conducted in more than one hospital within the United States?

"There are 8 locations for this clinical trial. A few notable locations include Memorial Sloan Kettering at Basking Ridge in Basking Ridge, Memorial Sloan Kettering Commack in Commack, and Uniondale's Memorial Sloan Kettering Nassau."

Answered by AI

Are there any life-threatening risks associated with Pembrolizumab?

"Pembrolizumab safety is estimated to be a 2. This comes from it being in Phase 2 testing which only has supporting data for safety and no efficacy."

Answered by AI

What therapeutic benefits has Pembrolizumab been shown to have?

"Pembrolizumab offers a treatment solution for patients suffering from malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

How many people are being allowed to participate in this trial?

"In order to carry out this study, we need 22 participants who meet the pre-determined inclusion criteria. These patients can come from different trial sites, such as Memorial Sloan Kettering at Basking Ridge in New jersey or Commack in Florida."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma
2017. "Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03179917.
~3 spots leftby Jun 2025
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