A Phase II Study of Ipilimumab and Nivolumab Immunotherapy plus Cabozantinib to Treat Rare Advanced Genitourinary Cancers

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Full Title

A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC) (A031702) (CIRB)

Purpose

The purpose of this study is to assess the safety and effectiveness of treating rare advanced genitourinary cancers with the immunotherapies nivolumab and ipilimumab plus the drug cabozantinib.

Nivolumab and ipilimumab take the brakes off the immune response, enabling immune cells to find and destroy cancer cells. Cabozantinib inhibits pathways that can fuel cancer growth. These drugs are already used to treat other cancers; their combination in this study is considered investigational. Nivolumab and ipilimumab are given intravenously (by vein) and cabozantinib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a metastatic rare genitourinary cancer that cannot be treated successfully with other therapies. Examples include rare cancers of urinary tract (bladder, renal pelvises, ureters, and urethra), such as adenocarcinoma, urachal carcinoma, squamous cell carcinoma, plasmacytoid carcinoma, micropapillary carcinoma, sarcomatoid carcinoma, and previously treated small cell carcinoma; rare testicular cancers, such as Sertoli-Leydig cell tumors; advanced previously treated small cell cancer of the prostate; and advanced penile cancer.
  • Patients should recover from the serious side effects of prior therapies.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Samuel Funt at 646-888-4770.

Protocol

20-371

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators