Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer

This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembroli

Trial Details

NCT ID
NCT06661720
Phase
PHASE3
Sponsor
Alliance for Clinical Trials in Oncology
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Pembrolizumab
  • Tivozanib
  • Biospecimen Collection
  • MRI
  • Computed Tomography
  • Biopsy
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Jonesboro, Arkansas, United States|35.8423,-90.70428
  • Auburn, California, United States|38.89657,-121.07689
  • Palo Alto, California, United States|37.44188,-122.14302
  • Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

  • • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the prim…
  • Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted
  • Intermediate-high risk RCC:
  • pT2 grade 4 or sarcomatoid features, N0M0

For full eligibility, visit ClinicalTrials.gov.

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