A Pilot Study of Neoadjuvant Combination Spartalizumab and Canakinumab Prior to Radical Nephrectomy in Patients with Localized Clear Cell Renal Cell Carcinoma (SPARC-1 Trial)

Contact:

NCT Number:

Protocol:

AAAS2814

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I

The purpose of this study is to study two experimental drugs called canakinumab and spartalizumab produced by Novartis to see if: • It is safe and feasible to give canakinumab and spartalizumab prior to radical nephrectomy? • Canakinumab and spartalizumab can kill cancer cells and bring immune cells into the kidney cancer when hen given to human subjects prior to radical nephrectomy? You are being asked to participate in this study because you have localized kidney cancer and you are planned to have a radical nephrectomy. People who usually have this do not receive any additional treatments prior to surgery despite significant risk that the cancer will recur. This is a pilot study to evaluate the safety and feasibility of a new treatment designed to target your body’s immune cells against your kidney cancer prior to surgery. Approximately 14 individuals will be asked to participate in this study.

Are you Eligible? (Inclusion Criteria)

  • Are you at least 18 years of age?
  • Do you have confirmed clear cell or predominantly clear cell RCC?
  • Are you able to go about everyday activities independently?

Specialty Area(s)

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032