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Antibody-Drug Conjugate
Brentuximab +/− Nivolumab for Lymphoma
Phase 2
Recruiting
Led By Ajay K. Gopal
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Resolution of all non-hematologic brentuximab vedotin-related and nivolumab-related adverse events (AEs) to < Grade 2
Relapsed or refractory CD30+ lymphoma that has either achieved < PR to brentuximab vedotin (minimum of 2 cycles), progressed while receiving brentuximab vedotin, or progressed within 6 months of the last dose of brentuximab vedotin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 weeks after completion of study treatment
Awards & highlights
Study Summary
This trial is testing brentuximab vedotin with or without nivolumab to see if it is effective in treating patients with CD30+ lymphoma.
Who is the study for?
This trial is for adults with CD30+ lymphoma that has returned or isn't responding to treatment. They must have certain blood counts, kidney and liver function within set limits, and a life expectancy over 90 days without treatment. Not eligible if they have significant neuropathy, intolerance to brentuximab vedotin, poor performance status, recent transplants or radioimmunotherapy, HIV/hepatitis B infection, pregnancy/breastfeeding without contraception use.Check my eligibility
What is being tested?
The study tests how well the drug Brentuximab Vedotin works alone or combined with Nivolumab in patients whose CD30+ lymphoma has relapsed or is refractory. It examines whether these treatments can stimulate the immune system to stop cancer growth more effectively than current methods.See study design
What are the potential side effects?
Potential side effects include nerve damage (neuropathy), reactions related to infusion of the drugs, fatigue, changes in blood counts leading to increased risk of infections or bleeding problems. Liver and kidney functions may also be affected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
All my side effects from brentuximab vedotin and nivolumab are mild.
Select...
My CD30+ lymphoma didn't respond well to brentuximab vedotin treatment.
Select...
My tumor cells show CD30 expression.
Select...
My kidney function is normal, based on creatinine levels or clearance.
Select...
I expect to complete at least 2 cycles of chemotherapy.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 weeks after completion of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 weeks after completion of study treatment
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 as measured by the Cheson 2007 criteria
Side 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
2Treatment groups
Experimental Treatment
Group I: Arm B (brentuximab vedotin, nivolumab)Experimental Treatment3 Interventions
Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (brentuximab vedotin)Experimental Treatment2 Interventions
Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Brentuximab Vedotin
2015
Completed Phase 4
~1070
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,726 Total Patients Enrolled
Ajay K. GopalPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
62 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a transplant in the last 100 days.My daily activity is significantly limited due to my health.All my side effects from brentuximab vedotin and nivolumab are mild.I am not pregnant or breastfeeding and agree to use effective contraception during and after the study.I have not had radioimmunotherapy in the last 3 months.I do not have an active infection or a lung condition that would prevent me from receiving treatment.I don't have autoimmune diseases, except possibly vitiligo or alopecia.My cancer can be measured on a scan and is larger than 1.5 cm.My CD30+ lymphoma didn't respond well to brentuximab vedotin treatment.My tumor cells show CD30 expression.My kidney function is normal, based on creatinine levels or clearance.I expect to complete at least 2 cycles of chemotherapy.My cancer has spread to my brain or spinal cord.I do not have severe numbness or pain from nerve damage.I have HIV, hepatitis B, or had PML before.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (brentuximab vedotin)
- Group 2: Arm B (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.
How large is the patient pool for this experiment?
"The information available on clinicaltrials.gov does verify that this trial is ongoing and actively recruiting patients. Originally posted on March 20th, 2013, this study is looking for 40 participants from a single site."
Answered by AI
Are there any volunteers needed for this research?
"From what is published on clinicaltrials.gov, this research is currently looking for participants. The trial was originally advertised on March 20th, 2013 and the information was most recently updated on October 4th, 2022."
Answered by AI
Which condition does Brentuximab Vedotin show the most promise in alleviating?
"Brentuximab Vedotin is the standard treatment for malignant neoplasms. However, this medication can also be used to manage other conditions like unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
Does Brentuximab Vedotin have the FDA's blessing?
"Brentuximab Vedotin, which is currently in Phase 2 clinical trials, has some evidence supporting its safety. However, there is no data at this time indicating that it is an effective treatment."
Answered by AI
Is this the first time Brentuximab Vedotin has been used in a research setting?
"Brentuximab Vedotin is being trialed in 802 different ongoing studies, with 89 of those trials in the third stage. Most of these clinical trials are taking place in Mexico City and Maryland; however, there are a total of 41548 locations running trials for Brentuximab Vedotin."
Answered by AI
What are the implications of this groundbreaking trial?
"Brentuximab Vedotin is being trialled in 802 live studies across the globe. The first study was completed in 2010 and involved 127 participants. 844 studies have completed since then."
Answered by AI
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