A Phase 2 Study Assessing the Addition of Stereotactic Radiation Therapy to Immunotherapy for People With Advanced Kidney Cancer

Full Title

Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI) (NRG-GU012) (CIRB)

Purpose

Researchers want to see if adding radiation therapy to standard medical treatments works better than standard therapies alone in people with kidney cancer. The standard therapies include:

• Immunotherapies, which boost the power of immune cells to find and destroy cancer cells. The standard immunotherapies used in this study may include nivolumab, ipilimumab, avelumab, and pembrolizumab.
• Anti-angiogenic drugs, which stop the formation of blood vessels that bring oxygen and nutrients to tumors. Anti-angiogenic drugs used in this study may include axitinib, cabozantinib, and lenvatinib.

If you join this study, you will be randomly assigned to receive standard medical therapy with or without stereotactic ablative radiation therapy (SABR). SABR uses special equipment to position a patient and deliver radiation to tumors with high precision.

Who Can Join

To join this study, there are a few conditions. You must:

• Have renal cell carcinoma that is inoperable (cannot be surgically removed) or metastatic (has spread).
• Not have had prior radiation therapy to the cancerous kidney.
• Not have had chemotherapy for metastatic kidney cancer within 3 months of getting the study therapy.
• Be able to walk and do routine activities for more than half the time you are awake.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Daniel Gorovets’ office at 212-639-3983.