A Phase III Study of Axitinib plus Avelumab Immunotherapy versus Sunitinib Alone in Patients with Previously Untreated Advanced Kidney Cancer

Full Title

A Phase 3, Multinational, Randomized, Open-Label, Parallel-Arm Study of Avelumab (MSB0010718C) in Combination with Axitinib (Inlyta®) Versus Sunitinib (Sutent®) Monotherapy in the First-Line Treatment of Patients with Advanced Renal Cell Carcinoma

Purpose

Axitinib and sunitinib are drugs used to treat kidney cancer. They work by inhibiting the blood vessels that tumors need to grow and spread. In this study, researchers are comparing the combination of axitinib plus the investigational drug avelumab with standard sunitinib treatment in patients newly diagnosed with advanced kidney cancer. The use of avelumab, the combination of avelumab with axitinib, and the use of axitinib in newly diagnosed patients is considered investigational.

Avelumab is a form of immunotherapy. It works by blocking a protein on tumor cells called PD-L1. Tumor cells make PD-L1 to help them evade being detected by the immune system. By blocking this protein, avelumab may improve the ability of the immune system to destroy a cancer.

Patients in this study will be randomly assigned to receive one of these treatments:

  • Axitinib plus avelumab
  • Sunitinib

Axitinib and sunitinib are taken orally (by mouth); avelumab is 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 inoperable or metastatic renal cell carcinoma that has not yet been treated.
  • 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. Robert Motzer at 646-422-4312.

Protocol

16-294

Phase

III

Investigator

Co-Investigators

Locations