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Checkpoint Inhibitor
Pembrolizumab + Radiation Therapy for Non-Hodgkin's Lymphoma
Phase 2
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My lymphoma is confirmed to be an aggressive type.
Select...
I have a lymphoma site that can be treated with radiation.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate of an unirradiated lesion to pembrolizumab with external beam radiation therapy
Secondary outcome measures
Complete response rate
Duration of response
Overall survival
+1 moreTrial 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
~3070
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,247 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,451 Total Patients Enrolled
Chelsea C PinnixPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to use birth control during the study.My lymphoma is confirmed to be an aggressive type.I have had a stem cell transplant from a donor.I have been diagnosed with a specific autoimmune disease.I have an immune system disorder or am taking steroid medication.I have active cancer in my brain or spinal cord.I have been treated for an autoimmune disease in the last 2 years.I have had lung inflammation or disease not caused by an infection.I have taken a pregnancy test within the last 3 days and it was negative.I have had radiation therapy on the area that may be targeted again.I have an active TB infection.I have not received a live vaccine in the last 30 days.I have a lymphoma site that can be treated with radiation.I have provided a sample of my tumor that has not been treated with radiation.I have received a cancer treatment drug from the monoclonal antibody group within the last 4 weeks.I have not had chemotherapy, targeted therapy, or radiation in the last 2 weeks.I have another cancer that is getting worse or needed treatment in the last 3 years.I don't have any health issues that could affect the trial's results.I have been treated with specific medications before.I am currently being treated for an infection.I am fully active or can carry out light work.I have a history of HIV or active hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (EBRT, pembrolizumab)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you provide an overview of the other experiments conducted using Pembrolizumab?
"Currently, there are 961 clinical trials regarding Pembrolizumab with 122 of these in Phase 3. While Houston, Texas has the most active sites for this research, a total of 35 731 locations worldwide are partaking in its studies."
Answered by AI
Is Pembrolizumab a secure therapy for patients?
"Though some evidence attests to the safety of Pembrolizumab, due its Phase 2 trial status there has yet to be any proof for its efficacy and thus it was rated a score of 2."
Answered by AI
Are new participants being accepted into the experiment currently?
"The records on clinicaltrials.gov suggest this experiment is currently recruiting participants, having been posted on November 1st 2017 and last amended May 19th 2021."
Answered by AI
How many individuals are engaged in this medical experiment?
"Affirmative. Information available at clinicaltrials.gov attests to this trial's ongoing recruitment efforts, which began on November 1st 2017 and were recently updated on May 19th 2021. The study is searching for 70 participants from one site."
Answered by AI
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