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Monoclonal Antibodies
Immunotherapy for Lymphoma
Phase 2
Waitlist Available
Led By Stephen D. Smith
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For DLBCL, patients must have relapsed after, declined, or considered ineligible for high-dose chemotherapy and autologous stem cell transplantation
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days after the last dose of pembrolizumab
Awards & highlights
Study Summary
This trial is testing a combination of two immunotherapy drugs to treat patients with either follicular lymphoma or diffuse large B cell lymphoma that has returned or doesn't respond to treatment. The immunotherapy drugs are pembrolizumab and either rituximab or obinutuzumab. Rituximab and obinutuzumab are monoclonal antibodies that bind to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. The drugs may help kill more cancer cells.
Who is the study for?
This trial is for adults with relapsed or refractory follicular lymphoma or diffuse large B cell lymphoma. They must have tried certain treatments like CD20 antibody therapy, not be eligible for high-dose chemotherapy and stem cell transplant, and lack better treatment options. Participants need a minimum hemoglobin level, measurable disease, good performance status (able to carry out daily activities), adequate organ function, and agree to use contraception.Check my eligibility
What is being tested?
The study tests pembrolizumab combined with either rituximab or obinutuzumab in patients whose lymphoma has returned after treatment or hasn't responded to previous therapies. Pembrolizumab is an immunotherapy drug that may help the immune system attack cancer cells; rituximab and obinutuzumab are antibodies targeting specific proteins on cancer cells.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, fever, chills, body aches similar to flu symptoms from rituximab or obinutuzumab. Pembrolizumab can cause immune-related adverse effects such as inflammation of organs like lungs (pneumonitis) or intestines (colitis), skin rash, liver enzyme elevation indicating liver inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My DLBCL has returned or I can't have high-dose chemo and stem cell transplant.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My kidney function is within the required range for the study.
Select...
My blood clotting time is normal or managed if I'm on blood thinners.
Select...
My lymphoma has returned or didn't respond to treatment.
Select...
My cancer can be measured and is at least 1.5 cm big.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 90 days after the last dose of pembrolizumab
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days after the last dose of pembrolizumab
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
Secondary outcome measures
Incidence of serious or drug-related adverse events
Overall survival (OS)
Progression-free survival (PFS)
Side 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
2Treatment groups
Experimental Treatment
Group I: Arm II (pembrolizumab, obinutuzumab)Experimental Treatment3 Interventions
INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2.
EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better, who are experiencing clinical benefit in the judgment of the investigator, may receive obinutuzumab IV on day 1 of cycles 5, 9, 13, 17, 21, and 25.
Group II: Arm I (pembrolizumab, rituximab)Experimental Treatment3 Interventions
INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2.
EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (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
2017
Completed Phase 2
~2010
Obinutuzumab
2015
Completed Phase 3
~3250
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,333 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,553 Total Patients Enrolled
Stephen D. SmithPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
2 Previous Clinical Trials
75 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My DLBCL has returned or I can't have high-dose chemo and stem cell transplant.I have or had lung inflammation not caused by an infection.I am currently being treated for an infection.I have been diagnosed with HIV.I have not received a live vaccine in the last 30 days.My condition worsened or didn't improve after treatment with rituximab.I am fully active or restricted in physically strenuous activity but can do light work.My kidney function is within the required range for the study.My blood clotting time is normal or near normal, even if I'm on blood thinners.I am a woman who can have children and have a recent negative pregnancy test.I've had cancer treatment within the last 2 weeks or still have side effects.My FL cancer has returned or didn't respond to treatment, and I've had CD20 antibody therapy with no better treatment options available.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.I have active brain metastases or cancer in the lining of my brain.I am not on steroids or immunosuppressants, except for necessary hormone replacement.I have an active tuberculosis infection.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.I have an autoimmune disease treated with medication in the last 2 years.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I am a man who can father a child and will use birth control during and for 12 months after the study.My blood clotting time is normal or managed if I'm on blood thinners.My lymphoma has returned or didn't respond to treatment.My cancer can be measured and is at least 1.5 cm big.I am willing to use birth control during and for 12 months after the study.I had a transplant from another person within the last 5 years.My liver enzymes are within the required range for the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (pembrolizumab, obinutuzumab)
- Group 2: Arm I (pembrolizumab, rituximab)
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.
How many volunteers are currently participating in this research study?
"This clinical trial has already completed candidate recruitment. It was initially unveiled on March 23rd 2018 and underwent its last review on July 20th 2022. Alternatively, there are 2661 studies searching for lymphoma patients, large b-cell diffuse sufferers, and 1445 trials specifically recruiting participants to receive Pembrolizumab treatment."
Answered by AI
What medical conditions is Pembrolizumab most frequently utilized for?
"The immunotherapy drug Pembrolizumab can be utilized to treat various conditions such as polyangium, malignant neoplasms, and unresectable melanoma."
Answered by AI
Could you please provide an overview of the research conducted on Pembrolizumab?
"At the present moment, there are 1,445 active clinical trials studying pembrolizumab. Out of these studies, 230 have reached Phase 3 and 54388 locations across the world are taking part in them. In particular, Houston has a high concentration of such trials."
Answered by AI
Is enrolment currently available for this research project?
"This trial is no longer open for recruitment. On March 23, 2018 it was first made available and the last update occured on July 20th 2022; however, other clinical trials are still actively seeking applicants with 4106 currently recruiting participants."
Answered by AI
Has the US Food and Drug Administration authorized Pembrolizumab?
"The safety of pembrolizumab is ranked as a 2 due to the lack of clinical data regarding its efficacy, though there are some studies that suggest it is safe."
Answered by AI
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