A Phase II Study of Avelumab Immunotherapy and Talazoparib in Patients with Metastatic Kidney Cancer Containing Certain Genetic Changes

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Full Title

Talazoparib and Avelumab in Genomically Defined Metastatic Renal Cell Carcinoma

Purpose

The purpose of this study is to assess the safety and effectiveness of combining two drugs, avelumab and talazoparib, to treat patients with metastatic renal cell carcinoma, a type of kidney cancer, that contains certain genetic mutations. Avelumab is a form of immunotherapy that works by blocking a protein on tumor cells called PD-L1. Tumor cells make PD-L1 to help them evade detection by the immune system. By blocking this protein, avelumab may improve the ability of the immune system to find and destroy a cancer.

Talazoparib stops the activity of a protein called PARP, which is involved in the repair of DNA damage. Some tumors with certain genetic mutations depend on PARP for DNA repair, while normal cells do not. This means that when talazoparib turns off PARP in cancer cells containing these mutations, uncontrolled DNA damage may result in cancer cell death.

Both of these drugs have been given safely to patients. In fact, by themselves, they are considered standard treatments for other cancers. Further, laboratory studies have shown that combining drugs that block PD-L1 and PARP may be more effective than using either drug by itself. Avelumab is given intravenously (by vein) and talazoparib is taken orally (by mouth). Their use together in this study and in patients with renal cell carcinoma is considered investigational.

Eligibility

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

  • Patients must have metastatic renal cell carcinoma with mutations in at least one of these genes: VHL, FH, or SDH.
  • Patients must have previously been exposed to other agents, including immunotherapy.
  • Patients who had prior treatment should recover from its serious side effects before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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. Martin Voss at 646-888-4721.

Protocol

19-195

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators