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Monoclonal Antibodies
Pembrolizumab + Brentuximab for T-Cell Lymphoma
Phase 2
Recruiting
Led By Tarsheen Sethi, MD
Research Sponsored by Sethi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For patients with peripheral T-cell lymphoma (PTCL): At least one measurable target lesion ≥1.5 cm
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial evaluates combining two drugs, pembrolizumab and brentuximab, in people with relapsed/refractory CD30 positive T-cell lymphoma. The goal is to increase response rate to ~65%. 43 people are needed to evaluate results.
Who is the study for?
Adults with a confirmed diagnosis of T-cell Non-Hodgkin lymphoma, including various subtypes like PTCL and CTCL, who have CD30 positive cells and have failed at least one prior therapy. Participants must be over 18, not pregnant or breastfeeding, willing to use contraception, and have good organ function. Exclusions include those with certain other health conditions or treatments that could interfere with the trial.Check my eligibility
What is being tested?
The study is testing the combination of Pembrolizumab and Brentuximab Vedotin in patients with relapsed/refractory T-cell lymphoma. It's an open-label phase 2 trial where both drugs are given for up to 16 cycles if effective; Pembrolizumab may continue for a total of 35 cycles. The goal is to see if this combo can achieve around a 65% overall response rate.See study design
What are the potential side effects?
Potential side effects from Pembrolizumab and Brentuximab Vedotin may include reactions at the infusion site, fatigue, nausea, blood cell count changes which can affect immunity and increase infection risk. Specific toxicities related to each drug are detailed in the protocol for dose adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a lymphoma with a detectable tumor larger than 1.5 cm.
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I am fully active or can carry out light work.
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I am 18 or older with a confirmed diagnosis of T-cell Non-Hodgkin lymphoma.
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My condition is a type of T-cell lymphoma confirmed by tests.
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My condition did not improve after at least one treatment.
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My biopsy shows I have CD30-positive cancer.
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I agree to use contraception during and after the treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The best overall response with the combination of brentuximab and pembrolizumab.
Secondary outcome measures
Duration of response
Occurrence of toxicity
Overall survival (OS)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Brentuximab vedotin (brentuximab) and pembrolizumabExperimental Treatment2 Interventions
All subjects are scheduled to receive up to 16 cycles of combinatorial treatment with brentuximab + pembrolizumab, followed by up to 19 additional cycles of pembrolizumab monotherapy.
After receiving 35 total doses of pembrolizumab (i.e. scheduled for 16 doses in the combinatorial setting and 8 doses as monotherapy), a subject's pembrolizumab treatment will be complete.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
2012
Completed Phase 2
~200
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
SethiLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,628 Total Patients Enrolled
Tarsheen SethiLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lymphoma with a detectable tumor larger than 1.5 cm.I am currently fighting an infection that needs treatment.I have not had radiotherapy in the last 2 weeks.I am fully active or can carry out light work.I have moderate to severe numbness, tingling, or pain in my hands or feet.I have previously been treated with specific medications.I have an immune system disorder or I am on long-term steroids.I have been diagnosed with adult T-cell leukemia/lymphoma.I have an active tuberculosis infection.I am a woman who meets specific health conditions.I had a stem cell transplant from a donor within the last 5 years or I have ongoing issues from the transplant.I have been treated for an autoimmune disease in the last year.I have been cancer-free for at least a year, with some exceptions.I have a history of HIV or Hepatitis B/C.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have had lung inflammation not caused by an infection.I have a significant history of liver problems.I am 18 or older with a confirmed diagnosis of T-cell Non-Hodgkin lymphoma.My condition is a type of T-cell lymphoma confirmed by tests.My cancer has spread to my brain or the membranes around my brain.My condition did not improve after at least one treatment.My biopsy shows I have CD30-positive cancer.I have not received a live vaccine in the last 30 days.I agree to use contraception during and after the treatment.I do not have severe heart failure or inflammation of the heart muscle.
Research Study Groups:
This trial has the following groups:- Group 1: Brentuximab vedotin (brentuximab) and 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.
Are there still slots available for participants in this research?
"This clinical trial, posted on February 24th 2023 and recently revised on March 14th 2023, is presently recruiting participants. Data about the study can be found hosted on clinicaltrials.gov."
Answered by AI
Have the FDA endorsed Brentuximab vedotin and pembrolizumab for public consumption?
"Our team at Power believes that the safety of brentuximab vedotin and pembrolizumab can be rated a 2 due to Phase 2 trials, which have not revealed efficacy but do provide some evidence on safety."
Answered by AI
To what extent is the population participating in this research project?
"Affirmative. The information posted on clinicaltrials.gov confirms that this research, which was originally published on February 24th 2023, is currently recruiting participants. Approximately 43 individuals are required at a sole medical institution."
Answered by AI
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