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Checkpoint Inhibitor
Pembrolizumab for Non-Hodgkin's Lymphoma
Phase 2
Waitlist Available
Led By Ajay K. Gopal
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Steady progression of follicular lymphoma (FL) and marginal zone lymphoma (MZL)
Must have indication for treatment (adapted from National Comprehensive Cancer Network [NCCN] 2015 guidelines) * Any of the following constitute an indication for treatment: Significant symptoms due to any iBCL: Which may include pain/discomfort, limitation of function, fatigue/malaise/constitutional symptoms, B-symptoms (fever, weight loss, night sweats), pruritus Threatened end-organ function due to any iBCL Progressive cytopenia secondary to any iBCL Steady progression of follicular lymphoma (FL) and marginal zone lymphoma (MZL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years
Awards & highlights
Study Summary
This trial studies pembrolizumab as a treatment for B-cell non-Hodgkin lymphoproliferative diseases.
Who is the study for?
This trial is for adults with untreated B-cell non-Hodgkin lymphoproliferative diseases who need treatment and have measurable disease. Participants must be in good physical condition (ECOG 0 or 1), not pregnant, willing to use birth control, and without serious health issues like active TB, HIV, certain cancers, CNS metastases, or severe autoimmune diseases.Check my eligibility
What is being tested?
The study tests pembrolizumab's effectiveness on patients with specific types of lymphoma. Pembrolizumab is an immunotherapy drug that may help the immune system fight cancer by blocking a pathway tumors use to hide from it.See study design
What are the potential side effects?
Pembrolizumab can cause side effects such as fatigue, skin reactions, diarrhea, lung inflammation (pneumonitis), hormonal gland problems (like thyroid dysfunction), and can worsen pre-existing autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma is getting worse over time.
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I have symptoms or conditions that require treatment according to NCCN guidelines.
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I have a tumor larger than 1.5 cm that can be measured by CT or MRI.
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My organ function is at risk due to my cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My blood cell counts are dropping due to my lymphoma.
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My kidney function is within the required range for the study.
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I have a tumor larger than 1.5 cm that can be measured by CT or MRI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 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 (Complete Response [CR] + Partial Response [PR] for Follicular Lymphoma and Marginal Zone Lymphoma)
Secondary outcome measures
Count of Participants Who Experience Adverse Events (AEs)
Duration of Response
Progression-free Survival
+1 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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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: Treatment (pembrolizumab)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
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?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,342 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,544 Total Patients Enrolled
Ajay K. GopalPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HIV.I need urgent treatment for my lymphoma complications.My platelet count is at least 25,000/uL or my low count is due to bone marrow issues.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.My lymphoma is getting worse over time.My kidney function is within the required range.My white blood cell count is high enough for treatment, or can be with help.My hemoglobin level is at least 8 g/dL, or lower if due to bone marrow issues.I am using two birth control methods or am not having sex to join this study.I agree to use birth control during and for 4 months after the study.I have a history of or currently have non-infectious lung inflammation.I have received treatment for iBCL before.I have only received the flu shot, not the nasal spray vaccine.I have a tumor larger than 1.5 cm that can be measured by CT or MRI.I have symptoms like pain, fatigue, fever, weight loss, or night sweats due to my cancer.My blood clotting time is normal or managed with medication.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have symptoms or conditions that require treatment according to NCCN guidelines.I am currently being treated for an infection.My organ function is at risk due to my cancer.I am fully active or restricted in physically strenuous activity but can do light work.I have an active tuberculosis infection.My blood cell counts are dropping due to my lymphoma.My condition requires treatment according to 2015 cancer guidelines.I have not received a live vaccine in the last 30 days.My blood clotting time is normal or near normal, or controlled if I'm on blood thinners.My kidney function is within the required range for the study.I have a tumor larger than 1.5 cm that can be measured by CT or MRI.I have cancer that has spread to my brain or spinal cord.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have another cancer, but it's either not growing or doesn't need treatment, except for certain skin cancers or cervical cancer that's been treated.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Pembrolizumab for medical use?
"Available evidence suggests that the safety of Pembrolizumab should be given a rating of 2, seeing as this is currently in Phase 2 trials and there are some data points to support its security but no proof yet for efficacy."
Answered by AI
To what disorders has pembrolizumab been most efficacious?
"Pembrolizumab has proven to be an effective intervention for patients with malignant neoplasms, inoperable melanoma, and a microsatellite instability high phenotype."
Answered by AI
What other research initiatives have employed Pembrolizumab?
"Currently, there are 961 trials in progress researching pembrolizumab. Of those studies, 122 have reached Phase 3 clinical trial status. Despite the majority of research being based out of Houston Texas, a total of 35,728 locations around the world offer this treatment as part of their medical study protocol."
Answered by AI
What is the cohort size of this medical research project?
"Affirmative. The clinicaltrials.gov report states that the trial, which was originally made available on July 9th 2018 and revised most recently on April 11 2022, is currently enrolling participants. 33 individuals are required to be recruited from 1 location."
Answered by AI
Is this experiment actively recruiting participants?
"As verified on clinicaltrials.gov, this medical research trial is currently recruiting patients. It was initially published on July 9th 2018 and most recently updated on April 11th 2022."
Answered by AI
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