Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center

About this trial

This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). The current Food and Drug Administration (FDA)-approved regimens for advanced kidney cancer fall into two categories. One treatment combination includes two immunotherapy drugs (nivolumab plus ipilimumab), which are delivered by separate intravenous infusions into a vein. The other combination is one immunotherapy drug (nivolumab infusion) plus an oral pill taken by mouth (cabozantinib). Nivolumab and ipilimumab are "immunotherapies" which release the brakes of the immune system, thus allowing the patient's own immune system to better kill cancer cells. Cabozantinib is a "targeted therapy" specifically designed to block certain biological mechanisms needed for growth of cancer cells. In kidney cancer, cabozantinib blocks a tumor's blood supply. The genetic (DNA) makeup of the tumor may affect how well it responds to therapy. Testing the makeup (genes) of the tumor, may help match a treatment (from one of the above two treatment options) to the specific cancer and increase the chance that the disease will respond to treatment. The purpose of this study is to learn if genetic testing of tumor tissue may help doctors select the optimal treatment regimen to which advanced kidney cancer is more likely to respond.

Eligibility criteria

Qualifiers

Histological confirmation of RCC with a clear cell component

Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer [AJCC] stage IV) RCC

Patient can comprehend and sign the study informed consent form

Male or female >= 18 years of age at the time of informed consent

Disqualifiers

Major surgery requiring general anesthesia

Inadequately controlled hypertension (systolic blood pressure [SBP] > 160/90 mmHg)

Anti-hypertensive medications are permitted.

Active infection requiring infusional treatment

Trial design

Treatments tested in this trial

  • Cabozantinib
  • Ipilimumab
  • Nivolumab

Treatment groups

54 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Vanderbilt-Ingram Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

United States Department of Defense

Collaborator