Aravive 003: AVB-S6-500 in patients with advanced or metastatic clear cell RCC - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an investigational drug called AVB-S6-500 (the study drug) is a safe and effective treatment for advanced or metastatic clear cell RCC. The study drug may work by preventing cancer cells from invading other parts of the body. People who join this study may or may not receive other cancer drugs in combination with the study drug.

What is the Condition Being Studied?

Advanced or Metastatic Clear Cell Renal Cell Carcinoma (RCC)

Who Can Participate in the Study?

Adults ages 18+ who:
- Are diagnosed with advanced or metastatic RCC
- Have not received any treatment for RCC yet; OR
- Have received only 1 previous treatment for RCC

For more information about who can join this study, please contact the study team at

Age Group

What is Involved?

If you choose to join this study, you will:
- Have imaging tests (CT and/or MRI)
- Have blood draws
- Give urine samples
- Be assigned to 1 of 3 study groups
-- One group will take the study drug alone
-- Another group will take the study drug in combination with cabozantinib
-- The final group will take the study drug in combination with cabozantinib + nivolumab

Your study group assignment will depend on what treatments you have previously received for your cancer.

The study drug and cabozantinib are pills that are taken by mouth every day. Nivolumab is given intravenously (through a needle in a vein in your arm) every 2 or 4 weeks, depending on what the study doctor thinks is appropriate.

Study Details

Full Title
A phase 1b/2 study of AVB-S6-500 in combination with cabozantinib, AVB-S6-500 in combination with cabozantinib and nivolumab, and AVB-S6-500 monotherapy in patients with advanced of metastatic clear cell renal cell carcinoma
Principal Investigator
Christopher Hoimes
Protocol Number
IRB: PRO00109797
NCT: NCT04300140
Phase I/II
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center