STRIKE

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.

In order to participate you must meet the following criteria:

• Have clear cell kidney cancer (RCC) and your main kidney tumor was completely removed (partial or radical nephrectomy).
• Have pathology that shows the cancer is intermediate-high risk or high risk (your doctor can confirm this from your surgical staging report).
• Have scans that show no evidence of cancer remaining (CT or MRI of the brain, chest, abdomen, and pelvis).
• Have had kidney surgery (and any approved treatment of small soft-tissue metastases) 4–16 weeks ago, you’ve recovered without major complications, and you’ve had no prior whole-body (“systemic”) treatment for RCC.
• Are 18 years of age or older.
• Are well enough for daily activities.
• Have acceptable blood/organ tests (kidney/liver/blood counts).
• Are not pregnant or breastfeeding.
• Have no certain uncontrolled/serious conditions (e.g., severe heart/lung inflammation, uncontrolled high blood pressure, serious infection, significant recent bleeding, organ transplant history, or autoimmune disease needing strong immune-suppressing meds). Controlled HIV/Hepatitis B/C may be allowed if viral load is undetectable.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.