Study on VSV-IFNβ-NIS with Ipilimumab and Nivolumab for Treating Advanced or Metastatic Clear Cell Kidney Cancer

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT07510334

Provider View

This clinical trial is exploring a new treatment combination for advanced or metastatic clear cell kidney cancer. It adds a modified virus, VSV-IFNβ-NIS, to the standard immunotherapy drugs ipilimumab and nivolumab to see if it can better target and kill cancer cells.

Patient Parameters

Program Overview

This phase II study is testing whether adding a lab-modified virus called VSV-IFNβ-NIS to the usual treatment of ipilimumab and nivolumab can help treat clear cell kidney cancer that has spread. The virus may kill cancer cells without harming normal cells, while the immunotherapy drugs help the immune system attack the cancer. The goal is to see if this combination is effective for treating advanced or metastatic clear cell kidney cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced or metastatic clear cell kidney cancer that cannot be cured with surgery or radiation.
  • Have measurable cancer based on specific medical criteria.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Have adequate blood counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test before joining.
  • Agree to provide blood and tissue samples for research.
  • Willing to return to Mayo Clinic for follow-up visits.

Exclusion Criteria

  • Pregnant or nursing women, or those not using effective birth control.
  • Have had previous treatment for advanced or metastatic kidney cancer.
  • Have certain types of blood clots in the liver.
  • Have received a live vaccine within 30 days before joining.
  • Have had recent surgery, chemotherapy, or radiation therapy.
  • Have severe heart disease or uncontrolled illnesses.
  • Have active infections or certain autoimmune diseases.
  • Are taking high doses of steroids or have a weakened immune system.
  • Have other active cancers needing treatment, except for certain skin or prostate cancers.
  • Have had a heart attack within the last 6 months.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Rochester55905RochesterMinnesota

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