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Monoclonal Antibodies
Brentuximab + Pembrolizumab + Chemotherapy for Hodgkin's Lymphoma
Phase 2
Recruiting
Led By Hun Lee, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial studies combining brentuximab vedotin and pembrolizumab with doxorubicin and dacarbazine to treat people with Hodgkin lymphoma.
Who is the study for?
This trial is for adults over 18 with untreated classic Hodgkin Lymphoma (cHL) at stage II with bulky disease or advanced stages III/IV. Participants must have measurable disease, be in good physical condition (ECOG 0-1), and have normal organ function. They should not be pregnant/breastfeeding and agree to use effective contraception. People with severe allergies, certain lung or liver diseases, neuropathy, heart conditions, HIV, recent infections or other cancers are excluded.Check my eligibility
What is being tested?
The study tests the combination of brentuximab vedotin and pembrolizumab with doxorubicin and dacarbazine in patients who haven't been treated for Stage II cHL with bulky mediastinal disease or advanced cHL (Stage III/IV). It aims to understand the effects of this drug combo on these specific lymphoma stages.See study design
What are the potential side effects?
Potential side effects include allergic reactions to medication components, nerve damage symptoms like tingling or numbness (neuropathy), blood disorders such as low neutrophil count which can increase infection risk; liver issues reflected by altered enzyme levels; kidney function changes; fatigue; and pregnancy-related risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part C: Standard Risk ArmExperimental Treatment4 Interventions
Group II: Part B: De-EscalationExperimental Treatment4 Interventions
Group III: Part A: Pembrolizumab and Brentuximab +ADExperimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Brentuximab vedotin
2012
Completed Phase 2
~200
Pembrolizumab
2017
Completed Phase 2
~2010
Dacarbazine
2005
Completed Phase 3
~5110
Find a Location
Who is running the clinical trial?
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
74,178 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,096 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,424 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use two forms of birth control during and for 7 months after the study if there's any chance of causing pregnancy.I have been treated with brentuximab vedotin before.I am not allergic to ingredients in my cancer drugs.I have received an organ or stem cell transplant.I, or my legal representative, have given written consent to participate.I am not on any other cancer treatment or experimental drugs.I haven't taken any herbal treatments for my condition in the last 2 weeks.I don't need strong medication for autoimmune disease or other conditions.My heart function is below normal, or I have heart disease symptoms, or I've had high doses of certain heart-affecting drugs.My condition is nodular lymphocyte-predominant Hodgkin lymphoma.I have had a stroke, heart attack, or severe heart symptoms in the last 6 months.I am 18 years old or older.I haven't had chemotherapy, radiation, or immunotherapy in the last 4 weeks, unless my disease got worse on treatment.I haven't had a severe infection in the last week.My liver function is moderately to severely impaired.I have a tumor larger than 1.5 cm that shows up on scans and is active on PET.My lung function is significantly reduced.I have been treated with specific immunotherapy drugs before.I am fully active or restricted in physically strenuous activity but can do light work.I have moderate to severe numbness, tingling, or muscle weakness.I haven't had any cancer other than non-dangerous types in the last 3 years.I am not pregnant or cannot become pregnant, confirmed by a recent test.I am receiving treatment for or to prevent graft-versus-host disease.I do not have active brain or spinal cord disease related to my cancer.I am scheduled for targeted radiation therapy after initial treatment.I have a severe lung condition not caused by my cancer.I need medication or have trouble with daily activities due to my neurological condition.I don't have any health issues that would stop me from receiving or handling the treatment.I have not received a live vaccine in the last 30 days.I have Hodgkin lymphoma at an advanced stage or with a large tumor.My Hodgkin's lymphoma diagnosis is confirmed and I can provide a tissue sample.I have lung disease that causes symptoms or could affect lung-related side effects from treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: Pembrolizumab and Brentuximab +AD
- Group 2: Part B: De-Escalation
- Group 3: Part C: Standard Risk Arm
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 Part A: Pembrolizumab and Brentuximab +AD?
"Our team has established that part A: Pembrolizumab and Brentuximab +AD is a safe intervention, evidenced by its Phase 2 status. Thus, it was granted an assessment of 2 on the 1-3 safety scale without any data to support its efficacy yet."
Answered by AI
Is the program currently accepting participants?
"As stated on clinicaltrials.gov, this medical study is no longer accepting candidates at the present moment. Having been initially uploaded to their website in September 30th 2023 and last edited June 20th 2023, it appears that recruitment has ended for now; however there are 1706 other trials actively recruiting patients presently."
Answered by AI
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