HCC 19-042: COSMIC-313 Study – Advanced Kidney Cancer

STUDY BASICS

Do you have advanced or metastatic kidney cancer (also called renal cell carcinoma) that has not yet been treated? If so, you may be eligible for a research study to help find out if the three-drug combination of cabozantinib, nivolumab, and ipilimumab is a safe and effective treatment for people with advanced or metastatic kidney cancer.

STUDY PURPOSE

Kidney cancer, also called renal cell carcinoma, is among the ten most common cancers, affecting more than 62,000 people each year in the United States. Advanced kidney cancer means the cancer has grown outside of the kidney or has spread to other parts of the body such as the lymph nodes, lungs, liver, or bones. Treatments for advanced kidney cancer can include surgery, chemotherapy, radiation, and immunotherapy, but the disease is often difficult to treat.

The purpose of this study is to find out if a three-drug combination of cabozantinib, nivolumab, and ipilimumab is a safe and effective treatment for people with advanced kidney cancer. Cabozantinib is an oral, targeted therapy designed to block activity that allows tumor cells to grow. Nivolumab and ipilimumab are intravenous (IV, injection in vein) immunotherapy drugs that in combination, are a standard of care for the treatment of kidney cancer. Although cabozantinib alone and the combination of nivolumab and ipilimumab are approved by the US Food and Drug Administration (FDA) to treat kidney cancer, the combination of cabozantinib, nivolumab, and ipilimumab has not been approved and is considered to be investigational.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18 and up
• Diagnosed with advanced or metastatic kidney cancer (also called renal cell carcinoma)
• Have not received any prior treatment for your advanced or metastatic cancer

WHAT PARTICIPANTS CAN EXPECT

Eligible participants will complete study-related tests that may include a physical examination, heart test (ECG), blood and urine tests, a health questionnaire, and imaging scans. Participants will be randomly assigned (like flipping a coin) to receive one of the following medication combinations, Group 1: Cabozantinib with nivolumab and ipilimumab, or Group 2: Placebo (no active drug) with nivolumab and ipilimumab.

Participants will be asked to come to the clinic about 10 times during the first 14 to 17 weeks and then once every 4 weeks thereafter while receiving study drugs. Study visits will take about 1-3 hours each. After stopping study medications, your study doctor may require that you complete additional tests, questionnaires and imaging scans, and/or contact you about every 12 weeks to follow your health status.