← Back to Search

Checkpoint Inhibitor

Pembrolizumab for Lymphoma

Phase 2
Recruiting
Led By John Plastaras, MD, PhD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Pathologically confirmed B-cell, T-cell, aggressive, or indolent non-Hodgkin lymphoma for whom pembrolizumab is clinically indicated per physician discretion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing whether combining the immunomodulatory agent pembrolizumab with low-dose radiotherapy can help treat patients with relapsed or refractory non-Hodgkin lymphoma.

Who is the study for?
Adults with relapsed/refractory non-Hodgkin lymphoma who have tried at least two prior therapies can join this trial. They must not be pregnant or breastfeeding, agree to use contraception, and have good organ function. Those with a history of certain cancers, severe allergies to pembrolizumab, active infections, or recent immunosuppressive treatments cannot participate.Check my eligibility
What is being tested?
The trial is testing the combination of pembrolizumab (an immune system-boosting drug) with low-dose radiotherapy on patients whose non-Hodgkin lymphoma has returned after treatment or didn't respond to previous treatments. The goal is to see how well this combo works in controlling the disease.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in various organs, skin reactions, hormone gland problems (like thyroid), and infusion-related reactions. Radiotherapy might cause localized skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer can be measured and has grown even after radiation.
Select...
My doctor recommends pembrolizumab for my confirmed non-Hodgkin lymphoma.
Select...
My disease did not respond to previous treatments.
Select...
My DLBCL or PMBCL cancer returned or didn't fully respond after a stem cell transplant.
Select...
My condition did not improve after two different treatments.
Select...
I have undergone at least 2 treatments for my condition, as agreed upon by my doctor and me.
Select...
I've recovered from side effects of CART therapy and have at least 2 measurable disease sites.
Select...
I am 18 or older with a confirmed diagnosis of relapsed/refractory non-Hodgkin lymphoma.
Select...
My disease did not respond to previous treatments.
Select...
I am not pregnant, breastfeeding, and I follow the required contraceptive guidance if applicable.
Select...
I've had at least 2 treatments for my condition and they didn't work, and I can't have a stem cell transplant.
Select...
I am 18 or older with a confirmed diagnosis of relapsed/refractory non-Hodgkin lymphoma.
Select...
My condition worsened after initially responding to treatment.
Select...
I have provided a recent or past biopsy of my tumor that has not been treated with radiation.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My recent tests show my organs are functioning well.
Select...
My condition did not improve after two different treatments.
Select...
I may or may not have had CART therapy before.
Select...
I agree to follow the contraception guidelines and not donate sperm for 120 days after my last treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
CR rate
Secondary outcome measures
Duration of best response
Duration of immunotherapy use for the pembrolizumab + RT induction CR cohort
Overall survival
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab and Radiation TherapyExperimental Treatment1 Intervention
pembrolizumab plus low-dose (4 Gy x 5) involved-site radiotherapy
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?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,055 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
385 Previous Clinical Trials
144,861 Total Patients Enrolled
John Plastaras, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
53 Total Patients Enrolled

Media Library

Non-Hodgkin's Lymphoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04827862 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Pembrolizumab and Radiation Therapy

Frequently Asked Questions

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

What are the possible dangers of Pembrolizumab?

"Pembrolizumab has received a score of 2 for safety. This is due to the fact that, while there is some evidence supporting its safety from Phase 2 trials, there is no data currently backing its efficacy."

Answered by AI

What are the main diseases that Pembrolizumab helps to fight?

"Pembrolizumab is a medication that oncologists often prescribe to treat malignant neoplasms. It can also be used as second-line therapy for unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

Does Pembrolizumab boast a solid clinical trial history?

"Pembrolizumab is being investigated in 1000 different clinical trials, 122 of which are currently ongoing. The majority of these active investigations are Phase 3 studies. Although the largest concentration of research is based in Houston, Texas; there are 36053 total locations running Pembrolizumab trials."

Answered by AI

Are there any current vacancies for participants in this trial?

"According to the latest information on clinicaltrials.gov, this trial is still recruiting patients. It was originally posted on December 1st, 2020 and updated for the last time on July 11th, 2020."

Answered by AI

How many people are able to enroll in this research project?

"Yes, according to the most recent information from clinicaltrials.gov, this trial is still recruiting patients. This particular study was first posted on December 1st, 2022 and last updated on July 11th, 2022. They are aiming to enroll 40 patients at a single location."

Answered by AI
~11 spots leftby Dec 2024