A Phase III Study of Standard Chemotherapy with Either Nivolumab Immunotherapy or Brentuximab Vedotin to Treat Newly Diagnosed Advanced Classical Hodgkin Lymphoma

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Full Title

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma (S1826)(CIRB)

Purpose

The purpose of this study is to see if adding the immunotherapy drug nivolumab to standard chemotherapy can extend the time to disease recurrence in children, teens, and adults with newly diagnosed advanced classical Hodgkin lymphoma, compared to the standard approach of chemotherapy plus brentuximab vedotin.

Nivolumab takes the brakes off the immune response by inhibiting a protein called PD-1. In doing so, it boosts the ability of the immune system to detect and destroy cancer cells. It is already used to treat classical Hodgkin lymphoma that has come back or continues to grow despite prior treatment; its use in newly diagnosed patients is considered investigational. Brentuximab vedotin has two parts: one (an antibody) that attaches to a protein on the surface of cancer cells called CD30, and another (an anticancer drug called monomethyl auristatin E) that kills the cancer.

Patients in this study will be randomly assigned to receive standard chemotherapy with either nivolumab or brentuximab vedotin. The treatments are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 12 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Christopher Forlenza at 212-639-5226.

Protocol

20-052

Phase

III

Disease Status

Newly Diagnosed