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Monoclonal Antibodies
Pembrolizumab + Brentuximab Vedotin for Hodgkin's Lymphoma
Phase 2
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-1
History of classic Hodgkin lymphoma by histopathology and now have relapsed or refractory disease after anthracycline-containing chemotherapy and eligible for high dose chemotherapy and autologous stem cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 months
Awards & highlights
Study Summary
This trial is testing if two new drugs can help treat Hodgkins lymphoma.
Who is the study for?
Adults with relapsed or refractory classic Hodgkin lymphoma after anthracycline chemotherapy, eligible for stem cell transplant. Must have a life expectancy over 90 days, stable organ function, and no severe active infections or immune conditions. Participants need to consent to treatment protocols and be willing to use effective contraception.Check my eligibility
What is being tested?
The trial is testing if Pembrolizumab and Brentuximab Vedotin are more effective than the GDP regimen (Dexamethasone, Cisplatin, Gemcitabine) followed by a stem cell transplant in shrinking or eliminating Hodgkin lymphoma.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, blood disorders like anemia or low platelets, nerve damage that can cause pain or numbness (neuropathy), fatigue, liver issues indicated by changes in enzymes levels, kidney function changes measured by creatinine clearance rate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My Hodgkin lymphoma returned or didn't respond after treatment with anthracycline, and I can undergo high dose chemotherapy and stem cell transplant.
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I will use effective birth control during and for 6 months after the study.
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I am 18 years old or older.
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My disease can be measured by exams or scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response rate by PET Deauville criteria (score 1-3) of pembrolizumab and brentuximab vedotin compared to standard GDP (gemcitabine, dexamethasone, cisplatin) given as salvage therapy
Secondary outcome measures
Event-free survival
Health Economics financial toxicity utilizing FACIT-COST
Health Economics utilizing EQ-5D-5L
+9 moreTrial Design
2Treatment groups
Active Control
Group I: Brentuximab vedotin + PembrolizumabActive Control2 Interventions
Group II: GDPActive Control3 Interventions
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,369 Total Patients Enrolled
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
74,144 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,062 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe health conditions that could make treatment unsafe for me.I have not had radiotherapy in the last 2 weeks.I have had a stroke or brain blood vessel event.I am fully active or can carry out light work.I can and will fill out health questionnaires in English or French.I am not currently on, nor have I recently been on experimental drugs or cancer treatments.I have received a transplant from a donor.I do not have any serious conditions that would make treatment unsafe for me.I have had or currently have lung inflammation treated with steroids.I do not have HIV, active Hepatitis B or C, or any uncontrolled infections.I will use effective birth control during and for 6 months after the study.My cancer tissue sample is available for further testing.I have a serious heart condition.I have had progressive multifocal leukoencephalopathy in the past.I have received treatment for my cancer after it came back or stopped responding to the first treatment.My Hodgkin lymphoma returned or didn't respond after treatment with anthracycline, and I can undergo high dose chemotherapy and stem cell transplant.I have had a severe reaction to the study drugs before.I have moderate to severe nerve pain or difficulty breathing.I am 18 years old or older.I have not taken steroids or immunosuppressants in the last week.I have an active brain or spinal cord disease.I have not received any live vaccines in the last 4 weeks.I have had cancer before, but it fits the exceptions.My blood, liver, and kidney tests are within normal ranges.My disease can be measured by exams or scans.
Research Study Groups:
This trial has the following groups:- Group 1: Brentuximab vedotin + Pembrolizumab
- Group 2: GDP
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 individuals are participating in this research endeavor?
"This trial necessitates the involvement of 84 eligible patients. The Research Institute of the McGill University in Montreal and London Regional Cancer Program are two of many locations providing this clinical opportunity."
Answered by AI
How many research centers are currently engaged in this experimental endeavor?
"The current clinical trial is enrolling at 5 different sites located in Montreal, London and Ottawa amongst others. If you choose to participate, it might be beneficial to pick the medical centre nearest your location so as to reduce travel needs."
Answered by AI
Is there any evidence that the combination of Brentuximab vedotin and Pembrolizumab is safe for patient use?
"Even though the efficacy of Brentuximab vedotin + Pembrolizumab has not been tested in a clinical setting, there is sufficient safety data to merit it receiving a score of 2."
Answered by AI
Is this experiment actively seeking participants at the present time?
"Affirmative. The information found on clinicaltrials.gov confirms that this medical trial is actively recruiting patients, and was initially posted on March 3rd 2022 before being updated most recently in November 14th 2022. This study needs 84 volunteers who are willing to be admitted across 5 different sites."
Answered by AI
Have researchers conducted any previous experiments combining Brentuximab vedotin and Pembrolizumab?
"In 1997, Brentuximab vedotin + Pembrolizumab was first trialled at City of Hope Comprehensive Cancer Center. To date there have been 2967 completed clinical trials and 2394 live studies. Notably, Montreal is a hub for these types of medical studies."
Answered by AI
What pathologies does the combination of Brentuximab vedotin and Pembrolizumab typically address?
"Brentuximab vedotin and Pembrolizumab are used to treat recurrent cervical cancer, as well as synovitis, refractory relapsed mediastinal large B-cell lymphoma, and ophthalmia sympathetic."
Answered by AI
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