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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 1, 2026 → Oct 1, 2027
See other at-risk trials from Vanderbilt-Ingram Cancer Center

Record History

  1. Notable Primary completion pushed from Oct 1, 2026 to Oct 1, 2027 Completion pushed from Jul 1, 2027 to Jul 1, 2028v12 Show 1 more changeShow less
    • Completion pushed from Jul 1, 2027 to Jul 1, 2028
  2. Notable Primary completion date: Oct 1, 2025 to Oct 1, 2026 Completion date: Jul 1, 2026 to Jul 1, 2027 · Start date: Dec 1, 2022 to Dec 6, 2022v11 Show 2 more changesShow less
    • Completion date: Jul 1, 2026 to Jul 1, 2027
    • Start date: Dec 1, 2022 to Dec 6, 2022
  3. Minor Primary completion date: Jul 1, 2025 to Oct 1, 2025v10
  4. Minor Collaborators: 1 to 2v9 See this version in full on ClinicalTrials.gov ↗
  5. Minor Study sites: 2 to 6v8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Study sites: 1 to 2v7
  2. Minor Eligibility criteria expanded, about 32 wordsv6 See this version in full on ClinicalTrials.gov ↗
  3. Minor Start date changed from estimate of Nov 15, 2022 to Dec 1, 2022v5
  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Nov 1, 2022 to Nov 15, 2022 · Site details revisedv4 Show 2 more changesShow less
    • Start date: Nov 1, 2022 to Nov 15, 2022
    • Site details revised
  5. Notable Start date: Sep 30, 2022 to Nov 1, 2022v3
  6. Notable Start date: Jul 1, 2022 to Sep 30, 2022v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05361720
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute (NCI), United States Department of Defense
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
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov