Brentuximab Vedotin and Nivolumab for Hodgkin Lymphoma

A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab

Recruiting Phase 3 Interventional Study
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
5 – 60
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,875 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for patients with early-stage classic Hodgkin lymphoma who have not yet started treatment. Participants will compare standard chemotherapy with a combination of two immunotherapy drugs to see which is more effective.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 5 and 60 years old.
  • I have been diagnosed with classic Hodgkin lymphoma.
  • I have measurable disease with at least one lesion of 1.5 cm or larger.
  • I have had a PET scan within the last 42 days.
  • I have a good performance status.
  • I am HIV positive but on effective treatment with an undetectable viral load.
  • I have undetectable hepatitis B or have been treated and cured for hepatitis C.

You may not be able to join if

  • I have nodular lymphocyte predominant Hodgkin lymphoma.
  • I have a history of active lung disease.
  • I have a serious uncontrolled illness.
  • I am currently using certain immunosuppressive medications.
  • I have severe peripheral neuropathy.
  • I have had another cancer that could affect this trial.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody call…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients must be 5 to 60 years of age at the time of enrollment * Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \[NOS\])…
Contacts

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