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Monoclonal Antibodies
Brentuximab Vedotin + Nivolumab for Hodgkin's Lymphoma
Phase 2
Recruiting
Led By Alex F Herrera
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine clearance of >= 40 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Histologically confirmed diagnosis of classical Hodgkin lymphoma (excluding nodular lymphocyte predominant Hodgkin lymphoma) according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of protocol treatment to time of disease relapse/progression or death due to any cause, assessed at 24 months
Awards & highlights
Study Summary
This trial is testing whether two drugs, brentuximab vedotin and nivolumab, can treat classical Hodgkin lymphoma that has come back. Brentuximab vedotin is a monoclonal antibody that is linked to a toxic agent called vedotin. Nivolumab is an antibody that enhances the immune system. Giving brentuximab vedotin and nivolumab may be able to defer stem cell transplant treatment.
Who is the study for?
This trial is for adults with classical Hodgkin lymphoma that has returned or didn't respond to first treatment. They must have had only one prior therapy, no severe allergies to the drugs being tested, and no active major diseases like heart problems or uncontrolled infections. Participants need normal organ function tests and agree to use birth control.Check my eligibility
What is being tested?
The study is testing brentuximab vedotin (an antibody-drug conjugate) combined with nivolumab (a drug boosting the immune system) in patients with relapsed/refractory classical Hodgkin lymphoma. The goal is to see if this combo can delay or replace stem cell transplant treatments.See study design
What are the potential side effects?
Possible side effects include nerve damage, allergic reactions, immune system complications like pneumonitis or colitis, fatigue, liver issues, and increased risk of infections due to a weakened immune response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are working well enough, as shown by a test.
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My diagnosis is classical Hodgkin lymphoma, not the nodular type, confirmed by a specialist.
Select...
I am able to get out of my bed or chair and move around.
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I have had only one previous treatment for my condition, excluding radiotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of protocol treatment to time of disease relapse/progression or death due to any cause, assessed at 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of protocol treatment to time of disease relapse/progression or death due to any cause, assessed at 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS) at 24 months in patients who achieve complete metabolic response (CMR) after 4 cycles of treatment
Secondary outcome measures
Complete metabolic response (CMR) rate
Incidence of adverse events
Overall response rate (ORR)
+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 30 minutes on day 1. Treatment repeats every 21 days for up to 16 cycles 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
~1070
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,629 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,101 Total Patients Enrolled
Alex F HerreraPrincipal InvestigatorCity of Hope Medical Center
11 Previous Clinical Trials
1,530 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a severe allergic reaction (grade 3 or higher) to brentuximab vedotin or nivolumab in the past.I was treated with BV or anti-PD-1/PD-L1, achieved complete remission, and haven't relapsed in 6 months.I have had progressive multifocal leukoencephalopathy in the past.My cervical cancer is in its early stages and has not spread.I am not eligible for a stem cell transplant due to my age, health conditions, or personal choice.I have or had hepatitis B or C, but it's currently not active.I haven't had a stroke, heart attack, or severe heart symptoms in the last 6 months.I do not have active lung inflammation or scarring.My cancer is not expected to need treatment for at least 2 years.I haven't had a platelet transfusion in the last 7 days.I have vitiligo.My kidneys are working well enough, as shown by a test.I use inhaled or topical steroids.I haven't taken high-dose steroids or immune-weakening drugs in the last 2 weeks.I am capable of having children and have not been surgically sterilized.My thyroid condition is well-managed with medication.I agree to provide a tissue sample from a recent or past biopsy.My diagnosis is classical Hodgkin lymphoma, not the nodular type, confirmed by a specialist.I am able to get out of my bed or chair and move around.I haven't used growth factors within a week before my white blood cell count test, unless my low count is due to my illness.I have not received a live vaccine in the last 30 days.My condition did not worsen within 3 months after my first treatment.I have had only one previous treatment for my condition, excluding radiotherapy.My hemoglobin level is at least 8 g/dL without recent transfusions.I take more than 10 mg of prednisone daily without having an active autoimmune disease.My lymphoma is causing my body to destroy red blood cells.I had skin cancer (not melanoma) and was treated to cure it.I have had cancer before, but it has been in remission for at least 3 years.My Type 1 diabetes is well-managed with treatment.My psoriasis can be managed without strong medication.I have HIV but it's under control with medication and my CD4 count is 200 or higher.My condition has worsened for the first time since treatment.I experience significant numbness or pain in my hands or feet.My lymphoma has spread to my brain or spinal cord.I have been diagnosed with an immune system disorder.You are currently receiving another experimental treatment for your condition.I'm sorry, but you haven't provided any specific criteria. Could you please provide the full criterion you would like me to rewrite?
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.
Is this clinical investigation currently open to new participants?
"Affirmative. According to clinicaltrials.gov, this medical experiment is currently seeking out volunteers. It was originally published on November 12th 2021 and amended February 16th 2022; 31 participants are needed at a single research centre."
Answered by AI
What evidence is there to support the safety of Brentuximab Vedotin?
"The safety profile of Brentuximab Vedotin was rated a 2 on the Power scale because there is only limited evidence of its efficacy, but some data that confirms its security."
Answered by AI
What is the extent of enrollment in this research endeavor?
"Indeed, the clinical trial portal states that this research is actively seeking participants. The initial posting was on November 12th 2021 and a recent update occurred on February 16th 2022. 31 individuals are sought to take part in the experiment at a single site."
Answered by AI
What health condition is Brentuximab Vedotin regularly prescribed for?
"Brentuximab Vedotin is a therapeutic agent typically used to combat malignant neoplasms, but can also be employed for the management of unresectable melanoma, squamous cell carcinomas and metastatic esophageal adenocarcinoma."
Answered by AI
Has Brentuximab Vedotin been tested in related clinical investigations?
"Currently, 765 clinical trials are being conducted to further study the effects of Brentuximab Vedotin. Of those active studies, 88 have progressed past Phase 3. Basel BE is home to the majority of these experiments; however, there are 41322 total sites worldwide where participants can receive this form treatment."
Answered by AI
Is this a pioneering clinical trial?
"Presently, 765 clinical trials for Brentuximab Vedotin are active in 2475 cities and 52 nations. Seagen Inc. initiated the first trial for this drug back in 2011 with 79 participants to complete Phase 2's requirements; over the decade since then, 304 further tests have been conducted."
Answered by AI
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