A Phase I Study Assessing the Combination of Immunotherapy and Targeted Chemotherapy to Treat Relapsed or Persistent Hodgkin Lymphoma

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Full Title

A Phase I Study with an Expansion Cohort/Randomized Phase II Study of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma (E4412) (CIRB)

Purpose

The purpose of this study is to assess a combination of the immunotherapy drugs nivolumab and ipilimumab with brentuximab vedotin in adolescents, young adults, and adults with Hodgkin lymphoma (Hodgkin disease) that has come back or continued to grow despite treatment. Patients will be randomly assigned to receive brentuximab vedotin with nivolumab OR brentuximab vedotin, nivolumab, and ipilimumab. All of these treatments are given intravenously (by vein).

Nivolumab and ipilimumab take the brakes off the immune response, boosting the ability of the immune system to detect and destroy cancer cells. 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.

Eligibility

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

  • Patients must have Hodgkin lymphoma that came back or continued to grow despite prior treatment.
  • At least 3 weeks must pass between the completion of prior therapies and receipt of the study treatment.
  • 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 about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

20-402

Phase

I/II

Co-Investigators