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Checkpoint Inhibitor

Nivolumab + Brentuximab Vedotin 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

Histologically confirmed diagnosis of classical Hodgkin lymphoma (excluding nodular lymphocyte predominant Hodgkin lymphoma) according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Must not have

Pregnancy, lactation, and cardiovascular conditions

Active central nervous system (CNS) involvement by lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first dose of study treatment to death from any cause, assessed up to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing nivolumab and brentuximab vedotin to see if they can help treat high-risk classical Hodgkin lymphoma.

Who is the study for?

This trial is for adults with high-risk classical Hodgkin lymphoma that's returned or isn't responding to treatment. They must have completed a stem cell transplant, be Brentuximab Vedotin naive or responsive, and meet specific health criteria including organ function tests. Women of childbearing potential and men must use effective contraception.

What is being tested?

The study is testing the effectiveness of Nivolumab and Brentuximab Vedotin after an autologous stem cell transplant (SCT). It aims to see if these immunotherapies can help the immune system fight cancer by preventing tumor growth and spread in patients with recurrent or refractory Hodgkin lymphoma.

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, fatigue, blood disorders like anemia or low platelet counts, possible nerve damage leading to neuropathy, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My diagnosis is classical Hodgkin lymphoma, not the nodular type, confirmed by a specialist.

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I can take care of myself but might not be able to do heavy physical work.

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My Hodgkin lymphoma has come back or is not responding to treatment.

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I am planning to have or have had a stem cell transplant using my own cells.

Exclusion Criteria

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

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I am not pregnant, breastfeeding, or have heart problems.

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My lymphoma affects my brain or spinal cord.

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I have received treatment for lymphoma after a stem cell transplant.

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I do not have any uncontrolled illnesses or infections.

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I have had a transplant from a donor.

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I am currently taking corticosteroids or immunosuppressive medications.

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I have or had lung inflammation or scarring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the first dose of study treatment to death from any cause, assessed up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the first dose of study treatment to death from any cause, assessed up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of study treatment to death from any cause, assessed up to 18 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-free Survival at 18 Months

Secondary study objectives

Overall Survival at 18 Months

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (brentuximab vedotin, nivolumab)Experimental Treatment3 Interventions

Beginning 30-60 days post-ASCT, 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 8 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Brentuximab Vedotin

2015

Completed Phase 3

~1080