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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 below
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I am not pregnant and will use birth control.
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My lymphoma is confirmed as Classical Hodgkin by a specialist.
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I haven't had chemotherapy, radiation, or specific cancer drugs before.
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I can take care of myself and perform daily activities.
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My liver and kidney tests are within normal ranges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

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 more

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT01990534
18%
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
~1070
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
5,018 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,317 Total Patients Enrolled
Bruce D ChesonPrincipal InvestigatorAcademic and Community Cancer Research United

Media Library

Brentuximab Vedotin (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT02758717 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Treatment (brentuximab vedotin, nivolumab)
Hodgkin's Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT02758717 — Phase 2
Brentuximab Vedotin (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02758717 — Phase 2
~5 spots leftby May 2025
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