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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 below

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All my side effects from brentuximab vedotin and nivolumab are mild.

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My CD30+ lymphoma didn't respond well to brentuximab vedotin treatment.

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My tumor cells show CD30 expression.

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My kidney function is normal, based on creatinine levels or clearance.

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I expect to complete at least 2 cycles of chemotherapy.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a transplant in the last 100 days.

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My daily activity is significantly limited due to my health.

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My cancer has spread to my brain or spinal cord.

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I do not have severe numbness or pain from nerve damage.

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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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and for arm a: up to 5 weeks after completion of study treatment. for arm b: within 6 months following 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

Paraesthesia

Pain in extremity

Weight decreased

Hypertension

Dysgeusia

Headache

Urticaria

Neutropenia

Hyperglycaemia

Peripheral motor neuropathy

Dizziness

Chills

Upper respiratory tract infection

Hyperuricaemia

Urinary tract infection

Muscle spasms

Anaemia

Constipation

Alanine aminotransferase increased

Skin infection

Insomnia

Cough

Cellulitis

Neuropathy peripheral

Multiple organ dysfunction syndrome

Drug eruption

Cancer pain

Diverticulitis

Sepsis

Impetigo

Sinusitis

Extravasation

General physical health deterioration

Musculoskeletal chest pain

Hypotension

Dry skin

Peripheral swelling

Hypertriglyceridaemia

Lower respiratory tract infection

Fracture

Lymphoma

Neck pain

Hepatocellular injury

Intestinal perforation

Haemolytic uraemic syndrome

Pancreatitis

Pulmonary embolism

Urinary retention

Stress

Aspartate aminotransferase increased

Staphylococcal skin infection

100%

80%

60%

40%

20%

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