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Monoclonal Antibodies

Immunotherapy + Chemotherapy for Hodgkin's Lymphoma

Phase 3

Waitlist Available

Led By Alex F Herrera

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) declared at registration

Performance status corresponding to Zubrod scores of 0, 1 or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of registration to date of first occurrence of efs event, assessed at 2 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether adding immunotherapy drugs to chemotherapy can better treat patients with newly diagnosed stage III or IV Hodgkin lymphoma.

Who is the study for?

This trial is for patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Eligible participants must be at least 12 years old, have measurable disease, and normal organ function. They should not be pregnant or nursing and agree to use contraception. Those with autoimmune diseases, prior malignancies (except certain treated cancers), or who received previous treatments for lymphoma are excluded.

What is being tested?

The study compares the effectiveness of two immunotherapy drugs—nivolumab and brentuximab vedotin—combined with chemotherapy in treating Hodgkin lymphoma. It aims to see if adding these drugs can better shrink tumors or delay symptom return compared to standard chemotherapy alone.

What are the potential side effects?

Potential side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, blood cell count changes increasing infection risk, nerve damage (neuropathy), and allergic responses due to the monoclonal antibodies nivolumab and brentuximab vedotin.

Eligibility Criteria

Inclusion Criteria

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

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I am registered to receive PET radiation therapy for remaining cancer.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I can provide a sample of my tumor for testing.

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I have never had a stem cell transplant from another person.

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I do not have an inherited or acquired immune deficiency.

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I have never had lung inflammation or scarring.

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My kidney function is within the required range for the trial.

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I have a tumor that is larger than 1.5 cm.

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I haven't needed treatment for an autoimmune disease in the last 2 years.

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I haven't taken high-dose steroids or immunosuppressants in the last 14 days.

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I do not have active hepatitis B or C.

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I have been diagnosed with stage III or IV classical Hodgkin lymphoma and have not received any treatment.

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I do not have lymphoma in my brain or spinal cord.

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I have not received a live vaccine in the last 30 days.

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I have had a specific scan within the last 42 days to check my disease.

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I have not had a stem cell transplant from a donor.

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I have not had a solid organ transplant.

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I am not pregnant or nursing and had a negative pregnancy test recently.

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I have not had chemotherapy, radiation, or antibody treatment for Hodgkin lymphoma, but I may have taken steroids.

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I am 12 years old or older.

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I am 12 years old or older.

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My most recent HIV test shows an undetectable or very low viral load.

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I have not had chemotherapy, radiation, or antibody treatment for Hodgkin lymphoma.

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My nerve damage does not severely affect my daily activities.

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I have been newly diagnosed with stage III or IV Hodgkin lymphoma and have not received any treatment.

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I am under 18 and will be treated as if I intend to continue with PET RT.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of registration to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of registration to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed at 2 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

Progression free survival (PFS)

Secondary study objectives

Event-free survival (EFS)

Incidence of adverse events

Metabolic complete response rate

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (chemotherapy, brentuximab vedotin, radiation)Experimental Treatment13 Interventions

Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.

Group II: Arm I (chemotherapy, nivolumab, radiation)Experimental Treatment13 Interventions

Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegfilgrastim

2013

Completed Phase 3

~4440

Dacarbazine

2005

Completed Phase 3

~5350