RecruitingPhase 2NCT05361720

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

Optimal Treatment by Invoking Biologic Clusters in Renal Cell Carcinoma (OPTIC RCC)


Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

54 participants

Start Date

Dec 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using genetic tumor testing to match people with advanced kidney cancer to the treatment most likely to work for their specific tumor profile, rather than using a one-size-fits-all approach. **You may be eligible if...** - Your kidney cancer has a clear cell component, confirmed by biopsy - Your cancer is advanced or has spread to other parts of the body (metastatic, stage IV) - You have not received any prior systemic treatment for kidney cancer - You are 18 or older with a Karnofsky performance status of 70% or higher - You understand and can sign the informed consent form **You may NOT be eligible if...** - You have received prior systemic therapy for kidney cancer - Your tumor type is not clear cell renal cell carcinoma - You are unable to tolerate the required biopsies - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCabozantinib

Given PO

BIOLOGICALIpilimumab

Given IV

BIOLOGICALNivolumab

Given IV


Locations(6)

City of Hope National Medical Center

Duarte, California, United States

Chao Family Comprehensive Cancer Center

Orange, California, United States

University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

University of Texas, Southwestern Medical Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05361720


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