A Phase II Study of Axitinib/Nivolumab Alone and with Ipilimumab or Radiation Therapy to Treat Previously Untreated Advanced Mucosal Melanoma

Full Title

Phase 2 study of Axitinib + PD-1 blockade in Mucosal Melanoma with Pilot Addition of Stereotactic Body Radiotherapy or Ipilimumab in Select Progressors

Purpose

The purpose of this study is to assess the safety and effectiveness of treatment with axitinib and nivolumab immunotherapy for people with advanced mucosal melanoma that has not yet been treated. Axitinib blocks the development of blood vessels that cancer cells need to grow and spread (“angiogenesis”). Nivolumab boosts the ability of the immune system to detect and destroy cancer cells.

Participants in this study who do not respond well to these two drugs may be offered one of two additional treatments:

• Axitinib and nivolumab plus ipilimumab, another immunotherapy drug, OR
• Axitinib and nivolumab plus stereotactic body radiotherapy (SBRT), which delivers a highly precise beam of radiation to a limited area and spares healthy tissue around the tumor.

Axitinib is taken orally (by mouth) and nivolumab and ipilimumab are given intravenously (by vein).