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PD-1 Inhibitor
Pembrolizumab for Lymphoma
Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has radiographically measurable cHL or PMBCL disease as per Lugano classification with at least 1 nodal lesion (which has not been previously radiated) that is >15 mm in long axis, regardless of the length of the short axis, and/or extranodal lesion of >10 mm in long and short axis.
- For participants who are ineligible for auto-SCT, have received at least ≥2 lines of prior therapy and have failed to respond to or relapsed after their last line of treatment. At least 1 of the prior lines of therapy must contain a rituximab-based regimen.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 40 months
Awards & highlights
Study Summary
This trial is testing whether the drug pembrolizumab can help treat people with Hodgkin lymphoma or primary mediastinal large B-cell lymphoma.
Who is the study for?
This trial is for adults with specific types of lymphoma (cHL or PMBCL) that have come back or didn't respond to treatment. They should be fairly healthy, able to perform daily activities with ease or only limited help, and not pregnant or breastfeeding. Participants need measurable disease, may have had certain prior treatments but not others like CAR-T therapy, and must not have serious heart issues or active infections.Check my eligibility
What is being tested?
The study tests Pembrolizumab given every six weeks to see how well it works against two kinds of lymphoma. The main goal is to check the percentage of patients whose cancer shrinks or disappears after treatment as judged by a set standard called Lugano classification criteria.See study design
What are the potential side effects?
Pembrolizumab can cause immune system-related side effects such as inflammation in various organs including lungs (pneumonitis), liver, intestines, hormone glands and skin. It might also lead to infusion reactions during drug administration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured on scans and has a large enough lesion that hasn't been treated with radiation.
Select...
I've had 2+ treatments for my condition and didn't respond well to the last one, including a treatment with rituximab.
Select...
My Hodgkin's lymphoma returned after my last treatment.
Select...
I've had at least one treatment for Hodgkin lymphoma and it didn't work or the cancer came back.
Select...
My PMBCL cancer has returned or is not responding to treatment.
Select...
My diagnosis is cHL or PMBCL, as confirmed by a lab test.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My Hodgkin lymphoma has returned or is not responding to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 40 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 40 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) per Lugano Classification as Assessed by Investigator
Secondary outcome measures
Antidrug Antibody Levels (ADA) for Pembrolizumab
Area Under the Curve (AUC) of Pembrolizumab
Duration of Response (DOR) per Lugano Classification as Assessed by BICR
+6 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Pembrolizumab (MK-3475), 400 mg, Q6W, intravenous (IV) infusion, Day 1 then Q6W up to 18 doses.
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?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,931 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,907 Previous Clinical Trials
5,065,970 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,789 Previous Clinical Trials
8,067,264 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I have received CAR-T cell therapy before.I have had a serious heart condition or stroke in the last 6 months.I had another cancer but have been cancer-free for 2 years, except for certain skin, bladder, cervical, or in situ cancers.I have been treated with specific immune therapy drugs before.My cancer can be measured on scans and has a large enough lesion that hasn't been treated with radiation.I haven't had monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.I am using effective birth control or have been abstinent, and will continue for 120 days after the study ends.I am on high-dose steroids (more than 10 mg of prednisone or equivalent) but started less than 3 days ago, except for daily replacement therapy.My lymphoma has spread to my brain or spinal cord.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am currently being treated for an infection.I have not received a live vaccine in the last 30 days.I have or had lung inflammation that needed steroids.My cancer returned or didn't respond well after my stem cell transplant.I can provide a recent or older lymph node biopsy for testing.I am not pregnant or breastfeeding.I've had 2+ treatments for my condition and didn't respond well to the last one, including a treatment with rituximab.My Hodgkin's lymphoma returned after my last treatment.I've had at least one treatment for Hodgkin lymphoma and it didn't work or the cancer came back.I have a history of Hepatitis B or active Hepatitis C.My PMBCL cancer has returned or is not responding to treatment.My diagnosis is cHL or PMBCL, as confirmed by a lab test.My organs are working well.I haven't had radiotherapy in the last 2 weeks and have no lung damage from past treatments.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I haven't had cancer treatment or major surgery in the last 4 weeks.I am fully active or restricted in physically strenuous activity but can do light work.I have had a solid organ transplant or a bone marrow transplant in the last 5 years.I have fluid around my heart or in my lungs.My Hodgkin lymphoma has returned or is not responding to treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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