A Phase I Study of Nivolumab Immunotherapy plus Standard Chemotherapy for Newly Diagnosed High-Risk Hodgkin Lymphoma

Full Title

IIT (CA209-447): Phase I/II of Nivolumab and A(B)VD in the Front-line Setting for Hodgkin Lymphoma

Purpose

The standard treatment for newly diagnosed high-risk Hodgkin lymphoma is chemotherapy with doxorubicin (Adriamycin), bleomycin, vinblastine, and dacarbazine (ABVD). Patients over age 60 receive this therapy without bleomycin (AVD) to reduce side effects.

In this study, researchers are assessing the safety and preliminary effectiveness of adding the immunotherapy drug nivolumab to ABVD or AVD therapy in patients with previously untreated Hodgkin lymphoma that has a high chance of recurrence. Nivolumab is already approved for treating recurrent Hodgkin lymphoma; its use in this study is investigational.

Nivolumab boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. Nivolumab blocks PD-1, enhancing the body’s ability to detect and destroy cancer cells.

All medications in this study 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 stage III or IV high-risk Hodgkin lymphoma that has not yet been treated.
  • This study is for patients age 18 and older. Those under age 60 will receive ABVD plus nivolumab, while those age 60 and older will receive AVD plus nivolumab.

For more information about this study and to inquire about eligibility, please contact Dr. Alison Moskowitz at 212-639-8889.

Protocol

16-1536

Phase

I/II

Investigator

Co-Investigators