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Antibody-Drug Conjugate
Nivolumab + Brentuximab Vedotin for Hodgkin's Lymphoma
Phase 2
Waitlist Available
Led By Bruce D Cheson
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of childbearing potential must have a negative pregnancy test and use contraception
Classical Hodgkin lymphoma determined by local hematopathology review
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
Study Summary
This trial is testing if two immunotherapies are effective in treating older patients with untreated Hodgkin lymphoma.
Who is the study for?
This trial is for older patients (60+) with untreated classical Hodgkin lymphoma. Participants must be in fairly good health, able to perform daily activities with little or no assistance, and have adequate organ function. They should not have severe concurrent diseases, active infections, or a history of certain autoimmune diseases. Pregnant women and those unwilling to use contraception are excluded.Check my eligibility
What is being tested?
The study is testing the combination of two drugs: Nivolumab (an immunotherapy that boosts the body's immune response against cancer cells) and Brentuximab Vedotin (a biological therapy that uses substances from living organisms to affect the immune system). The goal is to see if this combo works better for treating older adults with Hodgkin lymphoma.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions like fever or chills during drug administration, fatigue, blood disorders which can increase infection risk or cause anemia, digestive issues like nausea or diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and will use birth control.
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My lymphoma is confirmed as Classical Hodgkin by a specialist.
Select...
I haven't had chemotherapy, radiation, or specific cancer drugs before.
Select...
I can take care of myself and perform daily activities.
Select...
My liver and kidney tests are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Metabolic Response Rate
Secondary outcome measures
Duration of Response (DOR)
Number of Participants Experiencing at Least One Adverse Events Graded 3 or Higher Deemed at Least Possibly Related to Treatment
Number of Participants With an Overall Response of Complete Metabolic Response
+2 moreSide effects data
From 2020 Phase 4 trial • 60 Patients • NCT0199053418%
Pyrexia
12%
Peripheral sensory neuropathy
10%
Diarrhoea
10%
Neuropathy peripheral
10%
Neutropenia
8%
Polyneuropathy
8%
Nausea
8%
Anaemia
8%
Upper respiratory tract infection
7%
Arthralgia
7%
Vomiting
7%
Decreased appetite
5%
Hypomagnesaemia
5%
Hypokalaemia
5%
Paraesthesia
5%
Asthenia
5%
Bronchitis
5%
Cough
5%
Alopecia
3%
Oral herpes
3%
Abdominal pain
3%
Back pain
3%
Aspartate aminotransferase increased
3%
Alanine aminotransferase increased
3%
Constipation
3%
Nasopharyngitis
3%
Neutrophil count decreased
3%
Bone pain
3%
Headache
3%
Depression
3%
Thrombocytopenia
3%
Tachycardia
3%
Subcutaneous abscess
3%
Pruritus
3%
Rash
2%
Anaphylactic reaction
2%
Klebsiella infection
2%
Toothache
2%
Ligament sprain
2%
Chills
2%
Fatigue
2%
Blood alkaline phosphatase increased
2%
Lymphocyte count decreased
2%
Oedema
2%
Procedural pain
2%
Gamma-glutamyltransferase increased
2%
Catheter site inflammation
2%
Chest pain
2%
Renal tubular disorder
2%
Malaise
2%
Hyperuricaemia
2%
Influenza
2%
Lymphoedema
2%
Dengue fever
2%
Blood lactate dehydrogenase increased
2%
Facial nerve disorder
2%
Extravasation
2%
General physical health deterioration
2%
Hodgkin's disease
2%
Blood thyroid stimulating hormone increased
2%
Genital haemorrhage
2%
Upper respiratory tract inflammation
2%
Oedema peripheral
2%
Soft tissue inflammation
2%
Temperature regulation disorder
2%
Vaccination site pain
2%
Liver disorder
2%
Breast cellulitis
2%
Platelet count decreased
2%
Weight decreased
2%
Hyperglycaemia
2%
Pain in extremity
2%
Autonomic neuropathy
2%
Dysgeusia
2%
Somnolence
2%
Insomnia
2%
Device related infection
2%
Herpes zoster
2%
Hordeolum
2%
Conjunctivitis
2%
Coxsackie viral infection
2%
Leukocytosis
2%
Leukopenia
2%
Ear pain
2%
Autoimmune thyroiditis
2%
Diplopia
2%
Pseudomonas infection
2%
Sinusitis
2%
Viral infection
2%
Contusion
2%
Haemoglobin decreased
2%
Pneumonia
2%
Device related sepsis
2%
Septic shock
2%
Urinary tract infection
2%
Serum sickness-like reaction
2%
Cerebrovascular accident
2%
Anxiety
2%
Pleural effusion
2%
Vena cava thrombosis
2%
Dyspnoea
2%
Dyspnoea exertional
2%
Nasal congestion
2%
Dermatitis
2%
Dermatitis acneiform
2%
Dermatitis allergic
2%
Dermatitis contact
2%
Erythema
2%
Pruritus generalised
2%
Rash macular
2%
Rash maculo-papular
2%
Rash papular
2%
Rash pruritic
2%
Urticaria
2%
Haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin 1.8 mg/kg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (brentuximab vedotin, nivolumab)Experimental Treatment2 Interventions
Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 7 cycles and 6-8 weeks in cycle 8 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab Vedotin
2015
Completed Phase 4
~1100
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,090 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,226 Total Patients Enrolled
Bruce D ChesonPrincipal InvestigatorAcademic and Community Cancer Research United
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and will use birth control.I have an active autoimmune disease or recently took steroids or immunosuppressants.I have had chemotherapy or radiotherapy for Hodgkin lymphoma before.I have moderate to severe nerve pain or damage, and I haven't had cancer in the last 2 years.I do not have brain metastases or a history of pancreatitis.My lymphoma is confirmed as Classical Hodgkin by a specialist.I am 60 or older, or under 60 and can't have standard chemotherapy for health reasons.I need chemotherapy for my cancer, except if it's very early stage and only needs radiation.I haven't had chemotherapy, radiation, or specific cancer drugs before.I can take care of myself and perform daily activities.My liver and kidney tests are within normal ranges.I do not have HIV, AIDS, autoimmune diseases, or active hepatitis B or C.I am not allergic to the study drugs, do not have uncontrolled illnesses, and am not taking other investigational drugs.I do not have severe illnesses that could affect the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (brentuximab vedotin, nivolumab)
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.
What adverse effects have been observed with Brentuximab Vedotin usage?
"Brentuximab Vedotin, which is a phase 2 drug, has some evidence of safety but none that supports its efficacy, so it was given an assessment score of 2."
Answered by AI
What additional experiments have been done with Brentuximab Vedotin?
"At present, Brentuximab Vedotin is the subject of 765 live trials with 88 at Phase 3. In Switzerland's Zürich, BE specifically, there are several medical centres carrying out clinical research on this drug amongst a global total of 41322 locations."
Answered by AI
Are there multiple facilities conducting this experiment within the USA?
"Currently, the trial is running at 9 different medical sites. These include Rochester and Atlanta in addition to 7 other cities. To reduce commute times for participants, it's recommended that they select the clinic nearest their residence when enrolling."
Answered by AI
Is this a groundbreaking clinical trial?
"Brentuximab Vedotin was initially developed and tested in a clinical trial sponsored by Seagen Inc. in 2011, which included 79 participants. After its Phase 2 approval, this medication has become the subject of 765 active trials spanning 2475 cities and 52 countries globally."
Answered by AI
How many participants are being monitored for this medical examination?
"At the moment, this particular trial has reached its recruitment capacity. It was first published on May 13th 2016 and last modified July 20th 2022. If you are interested in other clinical studies, there are 1724 trials presently recruiting for hodgkin disease and 765 trials looking for patients taking brentuximab vedotin interventions."
Answered by AI
Is enrollment still available for the research study?
"Unfortunately, the recruitment period for this clinical trial has ended. The study was initially posted on May 13th 2016 and last edited on July 20th 2022. There are presently 1724 trials recruiting patients with Hodgkin's Disease and 765 studies searching for participants to try out Brentuximab Vedotin."
Answered by AI
Is Brentuximab Vedotin regularly employed to manage certain conditions?
"Brentuximab Vedotin is mainly used to treat malignant neoplasms, but can be beneficial in treating other medical conditions such as unresectable melanoma and squamous cell carcinoma. Additionally, it has been found to ameliorate metastatic esophageal adenocarcinoma."
Answered by AI
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