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Monoclonal Antibodies

Chemotherapy + Immunotherapy for Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Steven I Park

Research Sponsored by Academic and Community Cancer Research United

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Measurable disease (>= 1.5 cm) as assessed by 2 dimensional measurement by computed tomography (CT)

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

Must not have

Bulky disease (defined as a nodal mass measuring >= 10 cm by CT)

Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from registration to death due to any cause, assessed at 3 and 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to see if they're effective in treating Hodgkin lymphoma. The drugs work in different ways to stop the growth of cancer cells. The trial may improve survival of patients with stage I-II Hodgkin lymphoma.

Who is the study for?

This trial is for adults with previously untreated stage I-II non-bulky Hodgkin lymphoma. Participants must have measurable disease, adequate blood counts and organ function, no severe infections or other health conditions that could interfere with the study, not be pregnant or nursing, and agree to use contraception. Those with certain prior treatments, immunodeficiency, active hepatitis B or C, another primary malignancy within 3 years (with some exceptions), uncontrolled illnesses or known allergies to study drugs are excluded.

What is being tested?

The trial tests a combination of chemotherapy drugs (doxorubicin, vinblastine, dacarbazine) alongside brentuximab vedotin and nivolumab in patients with early-stage Hodgkin lymphoma. The aim is to see if this regimen can improve survival by killing cancer cells directly while also boosting the immune system's ability to fight cancer.

What are the potential side effects?

Potential side effects include reactions at the infusion site; damage to heart muscle; low blood cell counts leading to increased infection risk; fatigue; liver issues; allergic reactions. Nivolumab may cause immune-related side effects like inflammation in various organs.

Eligibility Criteria

Inclusion Criteria

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

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My cancer can be measured and is at least 1.5 cm big on a CT scan.

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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 white blood cell count is healthy without recent transfusions.

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My white blood cell count is healthy without needing a recent blood transfusion.

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My Hodgkin lymphoma is in an early stage and the tumor is smaller than 10 cm.

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I have taken a pregnancy test with negative results within the last week.

Exclusion Criteria

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

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I have a large tumor (10 cm or larger) according to a CT scan.

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I am not taking any experimental drugs for my cancer.

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I have not had severe infections, pancreatitis, stroke, or TIA in the recent past.

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I am currently on IV antibiotics for an infection.

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I have been diagnosed with HIV.

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I am currently breastfeeding.

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I have had radiation therapy targeting a specific area.

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My kidneys are not working well (creatinine clearance < 40 mL/min).

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I have heart problems that cause symptoms.

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I have an active tuberculosis infection.

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I am allergic to NVB or components in AVD + BV therapy.

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My cancer has spread to my brain or spinal cord.

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I need treatment that may affect my liver.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have been on high-dose steroids (more than 10 mg/day of prednisone or equivalent) for 2 weeks or more.

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I have not taken immunosuppressive drugs or steroids in the last 7 days.

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My liver is not working well (Child-Pugh score > 6).

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I have active hepatitis B or C.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am of childbearing age and do not plan to use birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from registration to death due to any cause, assessed at 3 and 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from registration to death due to any cause, assessed at 3 and 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from registration to death due to any cause, assessed at 3 and 5 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Duration of response

Incidence of adverse events

Heart rate

+6 more

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 (combination chemotherapy, nivolumab)Experimental Treatment6 Interventions

Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and dacarbazine IV over \>= 30 minutes, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET-positive then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. PET-positive patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. PET-negative patients receive nivolumab IV over 30 minutes on day 1 starting after AVD and BV treatment. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

2012

Completed Phase 3

~8030

Brentuximab Vedotin

2015

Completed Phase 3

~1080