A Phase II Study of Durvalumab and Tremelimumab Immunotherapy to Treat Persistent or Recurrent Germ Cell Tumors

Full Title

A Single-Arm, Phase II Study of Durvalumab (MEDI4736) and Tremelimumab for Relapsed/Refractory Germ Cell Tumors

Purpose

The purpose of this study is to assess the safety and effectiveness of the immunotherapy drugs durvalumab and tremelimumab when given together in patients with germ cell tumors that have continued to grow or came back despite other treatment.

Durvalumab is designed to boost the body’s immune system by targeting a protein on tumor cells called PD-L1. PD-L1 normally maintains the balance of the immune system. In cancer, PD-L1 helps tumors escape detection and destruction by the immune system. Durvalumab may increase the immune system’s ability to identify and destroy cancer cells. It is used to treat bladder cancer; its use in this study is considered investigational.

Tremelimumab is an investigational drug that blocks CTLA4, a protein found on cells of the immune system. CTLA4 puts the brakes on the immune response and may prevent immune cells from attacking cancer cells. Tremelimumab prevents this from happening, potentially enhancing the immune response against the cancer.

Both durvalumab and tremelimumab 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 with a germ cell tumor that has continued to grow or came back despite at least one prior regimen of chemotherapy and high-dose chemotherapy with a stem cell transplant may participate. Patients who have a germ cell tumor that has continued to grow or came back despite at least one prior regimen of chemotherapy and who are not candidates for high-dose chemotherapy with a stem cell transplant are also eligible.
  • At least 2 weeks must pass between the completion of previous treatment and entry into the study.
  • 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 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Samuel Funt at 646-422-4558 or Dr. Darren Feldman 646-422-4491.

Protocol

17-160

Phase

II

Investigator

Co-Investigators