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NCT05361720 · ClinicalTrials.gov registry record · Phase 2
Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study
A Phase 2 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8, sponsored by Vanderbilt-Ingram Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 6
- Study locations
NCT05361720 is a Phase 2 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8 that is actively recruiting participants, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 54 participants, below the 150-participant average among 24 other Stage IV Renal Cell Cancer AJCC v8 trials with a reported enrollment target (64% lower). The trial reports 6 study locations across 4 states.
The verdict
NCT05361720, a Phase 2 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8, is actively recruiting participants, sponsored by Vanderbilt-Ingram Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 6
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- DRUG Cabozantinib
- BIOLOGICAL Ipilimumab
Study Locations (6)
California
- City of Hope National Medical Center - Duarte
- Chao Family Comprehensive Cancer Center - Orange
Ohio
- University Hospitals Seidman Cancer Center - Cleveland
- Cleveland Clinic - Cleveland
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Texas
- University of Texas, Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2022-12-01 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05361720
The ClinicalTrials.gov registry entry for NCT05361720 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 150-participant average among 24 other Stage IV Renal Cell Cancer AJCC v8 trials with a reported enrollment target (64% lower). The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Stage IV Renal Cell Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT05361720 reports 6 study locations spanning 4 distinct geographic areas - top geographies include California, Ohio, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05361720 about?
NCT05361720 is a clinical study titled "Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study". 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)-a...
What is the current status of trial NCT05361720?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2022-12-01. Estimated completion is 2026-07-01.
What conditions does trial NCT05361720 study?
This clinical trial studies the following conditions: Stage IV Renal Cell Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma.
What interventions are being tested in trial NCT05361720?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Cabozantinib (DRUG), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05361720?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05361720 being conducted?
This trial has 6 study locations across California, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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