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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
Must not have
Prior transplant within 100 days
Eastern Cooperative Oncology Group (ECOG) performance status > 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 weeks after completion of study treatment
Awards & highlights

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.
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.
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 below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had a transplant in the last 100 days.
Select...
My daily activity is significantly limited due to my health.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I do not have severe numbness or pain from nerve damage.
Select...
I have HIV, hepatitis B, or had PML before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 weeks after completion of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 weeks after completion of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate as measured by the Cheson 2007 criteria

Side effects data

From 2018 Phase 3 trial • 131 Patients • NCT01578499
47%
Peripheral sensory neuropathy
36%
Nausea
27%
Diarrhoea
27%
Fatigue
17%
Vomiting
17%
Pruritus
15%
Alopecia
15%
Decreased appetite
14%
Pyrexia
12%
Myalgia
12%
Arthralgia
11%
Asthenia
11%
Oedema peripheral
11%
Rash maculo-papular
11%
Dyspnoea
11%
Pruritus generalised
9%
Paraesthesia
9%
Pain in extremity
9%
Weight decreased
9%
Hypertension
8%
Dysgeusia
8%
Headache
8%
Urticaria
8%
Neutropenia
8%
Hyperglycaemia
6%
Peripheral motor neuropathy
6%
Dizziness
6%
Chills
6%
Upper respiratory tract infection
6%
Hyperuricaemia
6%
Urinary tract infection
6%
Muscle spasms
5%
Anaemia
5%
Constipation
5%
Alanine aminotransferase increased
3%
Skin infection
3%
Insomnia
3%
Cough
3%
Cellulitis
2%
Drug eruption
2%
Cancer pain
2%
Diverticulitis
2%
Sepsis
2%
Impetigo
2%
Sinusitis
2%
Extravasation
2%
General physical health deterioration
2%
Multiple organ dysfunction syndrome
2%
Neuropathy peripheral
2%
Musculoskeletal chest pain
2%
Hypotension
2%
Dry skin
2%
Peripheral swelling
2%
Hypertriglyceridaemia
2%
Lower respiratory tract infection
2%
Fracture
2%
Lymphoma
2%
Neck pain
2%
Hepatocellular injury
2%
Intestinal perforation
2%
Haemolytic uraemic syndrome
2%
Pancreatitis
2%
Pulmonary embolism
2%
Urinary retention
2%
Stress
2%
Aspartate aminotransferase increased
2%
Staphylococcal skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin
Methotrexate or Bexarotene

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
Brentuximab Vedotin
2015
Completed Phase 3
~1080
Nivolumab
2014
Completed Phase 3
~5220

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,791 Previous Clinical Trials
1,905,466 Total Patients Enrolled
Ajay K. GopalPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
62 Total Patients Enrolled

Media Library

Brentuximab Vedotin (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT01703949 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Arm A (brentuximab vedotin), Arm B (brentuximab vedotin, nivolumab)
Hodgkin's Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT01703949 — Phase 2
Brentuximab Vedotin (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01703949 — Phase 2
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