A Phase I/II Study of Brentuximab Vedotin plus Nivolumab Immunotherapy in Patients with Recurrent or Persistent Hodgkin Lymphoma

Full Title

SGN35-025: A Phase 1/2 Study Evaluating Brentuximab Vedotin in Combination with Nivolumab in Patients with Relapsed or Refractory Hodgkin Lymphoma After Failure of Frontline Therapy

Purpose

Brentuximab vedotin is used to treat patients with Hodgkin disease that has come back or continued to grow despite prior therapy. Brentuximab 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.

Doctors are interested in making treatment even more effective for recurrent or persistent Hodgkin lymphoma. In this study, researchers are evaluating the safety and effectiveness of brentuximab combined with the immunotherapy drug nivolumab in patients with Hodgkin lymphoma that has come back or continued to grow after other treatments.

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. It is approved for treating several types of cancer; its use in this study is considered investigational.

Both brentuximab and nivolumab 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 recurrent or persistent Hodgkin lymphoma that came back or continued to grow after initial therapy.
  • At least 4 weeks must pass after completion of prior chemotherapy and 3 weeks since prior radiation therapy and entry into the study.
  • Patients may not have previously received immunotherapy or an autologous stem cell transplant.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alison Moskowitz at 212-639-4839.

Protocol

16-045

Phase

I/II

Investigator

Co-Investigators