A Phase III Study of Brentuximab Vedotin Alone and with Nivolumab Immunotherapy in Patients with Recurrent or Persistent Hodgkin Lymphoma

Full Title

CA209812: Randomized, Open-label, Phase 3 Trial of Nivolumab plus Brentuximab vedotin versus Brentuximab vedotin alone in Participants with Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 812)

Purpose

The purpose of this study is to see if adding nivolumab immunotherapy to brentuximab vedotin is more effective than brentuximab vedotin alone for patients with classical Hodgkin lymphoma that has come back or continued to grow despite treatment and for whom autologous (self) stem cell transplantation is not an option.

Nivolumab is a form of immunotherapy. It 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 used to treat several cancers, including Hodgkin lymphoma that persists after stem cell transplantation.

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. Its use in combination with nivolumab is considered investigational.

In this study, patients will be randomly assigned to receive brentuximab vedotin alone or with nivolumab. Both drugs 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 advance classical lymphoma that has come back or continued to grow despite prior treatment.
  • Patients may have already had an autologous stem cell transplant (more than 30 days before entering the study) or must not be candidates for this procedure.
  • At least 4 weeks must pass since the completion of prior chemotherapy or antibody therapy, 3 weeks since radiation therapy, and 2 weeks since major surgery and entry into the study.
  • Prior treatment with PD-1 or PD-L1 inhibitors is not permitted.
  • 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

17-423

Phase

III

Investigator

Co-Investigators