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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 for arm a: up to 5 weeks after completion of study treatment. for arm b: within 6 months following treatment.
Awards & highlights
No Placebo-Only Group
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 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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ for arm a: up to 5 weeks after completion of study treatment. for arm b: within 6 months following treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for arm a: up to 5 weeks after completion of study treatment. for arm b: within 6 months following treatment.
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 • NCT0157849947%
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%
Multiple organ dysfunction syndrome
2%
Neuropathy peripheral
2%
Drug eruption
2%
Cancer pain
2%
Diverticulitis
2%
Sepsis
2%
Impetigo
2%
Sinusitis
2%
Extravasation
2%
General physical health deterioration
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2015
Completed Phase 3
~4010
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,831 Previous Clinical Trials
1,907,529 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.