A Phase II Study of Nivolumab Immunotherapy Alone and with Cabozantinib to Prevent Mucosal Melanoma Relapse after Surgery

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Full Title

A Randomized Phase II Trial of Adjuvant Nivolumab with or Without Cabozantinib in Patients with Resected Mucosal Melanoma (A091903) (CIRB)

Purpose

The purpose of this study is to assess the safety and effectiveness of nivolumab immunotherapy alone and with the drug cabozantinib to reduce the chance that mucosal melanoma will come back after surgery. Nivolumab boosts the power of the immune system to detect and destroy cancer cells. Cabozantinib inhibits cancer cell growth by blocking certain enzymes.

Participants whose cancers have been fully removed through surgery will be randomly assigned to receive nivolumab with a placebo (inactive drug) or with cabozantinib. Those whose cancer has not been fully removed or has spread will receive nivolumab with cabozantinib. Nivolumab is given intravenously (by vein) and cabozantinib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have mucosal melanoma (arising in the mouth, nose, anus, or genital or urinary tracts) and have planned or undergone surgery to fully remove it.
  • Patients may not have received prior treatment with immunotherapy drugs such as nivolumab.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Alexander Shoushtari at 646-888-4161.

Protocol

22-202

Phase

II

Disease Status

Newly Diagnosed

Co-Investigators

Diseases