About this trial

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 pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.

Eligibility criteria

Qualifiers

• Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)

Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted

pT2 grade 4 or sarcomatoid features, N0M0

pT3 any grade N0, M0

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Pembrolizumab
  • Tivozanib
  • Biospecimen Collection
  • MRI
  • Computed Tomography
  • Biopsy
  • Questionnaire Administration

Treatment groups

1,040 Participants
are divided into 2 treatment groups

Locations

415
Arizona
Cancer Center at Saint Joseph's85004, Phoenix United States
Banner University Medical Center - Tucson85719, Tucson United States
University of Arizona Cancer Center-North Campus85719, Tucson United States
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro72401, Jonesboro United States

Sponsors and collaborators

Alliance for Clinical Trials in Oncology

Lead sponsor