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Advanced Clear Cell Renal Cell CarcinomaGeneticsDrugBiologicalPhase 2

What this study is

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.

What's being tested

  • Cabozantinib

    Intervention · DRUG

    Given PO

  • Ipilimumab

    Intervention · BIOLOGICAL

  • Nivolumab

    Intervention · BIOLOGICAL

Both Ipilimumab and Nivolumab

Given IV

Study details

Official title
Optimal Treatment by Invoking Biologic Clusters in Renal Cell Carcinoma (OPTIC RCC)
Sponsor
Vanderbilt-Ingram Cancer Center
Conditions
Advanced Clear Cell Renal Cell Carcinoma · Metastatic Clear Cell Renal Cell Carcinoma · Stage III Renal Cell Cancer AJCC v8 · Stage IV Renal Cell Cancer AJCC v8
Enrolling
54 people
Starts
2022-12-06
Est. completion
2028-07-01
Design
Open-label, non-randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗