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Monoclonal Antibodies

Brentuximab + Nivolumab for Hodgkin's Lymphoma

Phase 2

Waitlist Available

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

Must have prior to standard of care ABVD treatment at least one lesion that is > 1.5 cm in the longest diameter on cross-sectional imaging and measureable in two perpendicular dimensions on CT and fludeoxyglucose (FDG) avid by PET

Stage IA, IB, IIA, or IIB cHL by Cotswold modified Ann Arbor staging done prior to any treatment with ABVD

Must not have

History of progressive multifocal leukoencephalopathy (PML)

Females only: pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing brentuximab vedotin and nivolumab to see if they work well in treating patients with early-stage Hodgkin lymphoma.

Who is the study for?

This trial is for patients with early stage classic Hodgkin lymphoma (stages IA, IB, IIA, or IIB). Participants must have a specific type of tumor that's visible and measurable on scans. They should be relatively healthy overall (ECOG ≤ 2) and not have had much prior treatment for their lymphoma—up to two cycles of ABVD chemotherapy are okay. People with severe neuropathy, other recent cancers, certain heart conditions, known allergies to the drugs used in this study or their components, active infections like hepatitis B/C or HIV (with some exceptions), autoimmune diseases, or those who are pregnant/breastfeeding cannot join.

What is being tested?

The trial is testing brentuximab vedotin combined with nivolumab against classic Hodgkin lymphoma. Brentuximab vedotin targets cancer cells by attaching to them and delivering a toxic agent called vedotin. Nivolumab works by helping the immune system attack cancer cells more effectively. The study aims to see how well these treatments work together in early-stage patients.

What are the potential side effects?

Possible side effects include reactions at the infusion site where the drug enters the body through a vein; nerve damage causing numbness or tingling; fatigue; immune-related effects where the body attacks its own tissues; increased risk of infections due to weakened immunity; and potential harm if you're pregnant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a cancer lesion larger than 1.5 cm that shows up on scans and is active on PET.

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My Hodgkin's lymphoma is in an early stage (IA, IB, IIA, IIB) according to the Cotswold/Ann Arbor system.

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I can take care of myself and am up and about more than half of the day.

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My diagnosis is classical Hodgkin lymphoma, not the nodular lymphocyte-predominant type.

Exclusion Criteria

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

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I have had progressive multifocal leukoencephalopathy in the past.

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I am not pregnant or breastfeeding.

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I have a known brain or spinal cord condition.

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I have active lung inflammation.

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I do not have uncontrolled heart problems.

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I do not have severe numbness, tingling, or muscle weakness.

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I have a history of pancreatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

18-month Progression-free survival (PFS) for each arm of therapy

Secondary study objectives

3-year PFS for each arm of treatment

Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0

Overall survival for each arm of treatment

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group II (AVD, brentuximab vedotin, nivolumab)Experimental Treatment6 Interventions

Patients receive doxorubicin IV, vinblastine IV, dacarbazine, IV and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients that are PET/CT negative receive nivolumab IV over 60 minutes on day 1. Treatment with nivolumab repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Group I Arm B (ABVD, nivolumab)Experimental Treatment6 Interventions

Patients receive doxorubicin IV, bleomycin IV, vinblastine IV, dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Treatment with nivolumab repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group III: Group I Arm A (brentuximab vedotin, nivolumab)Experimental Treatment3 Interventions

Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vinblastine

1998

Completed Phase 3

~5410

Nivolumab

2015

Completed Phase 3

~4010