Clinical Trials | Pilot Phase II Trial Evaluating Safety and Feasibility of Neoadjuvant Botensilimab and Balstilimab in Clear Cell Renal Cell Carcinoma (NEO RoBOT)

The University of Virginia is conducting a clinical research study for adults ages 18 years and older with high-risk, non-metastatic clear cell renal cell carcinoma who are planning surgery to remove their kidney cancer. The purpose of this study is to evaluate the safety and feasibility of botensilimab and balstilimab given before surgery. These are immunotherapy medicines designed to help the immune system recognize and attack cancer cells. The study drugs may or may not shrink the cancer and may cause side effects. The study team will also evaluate how the cancer responds to treatment and follow participants after surgery to assess whether the cancer returns. Botensilimab and balstilimab are investigational for clear cell renal cell carcinoma and are not approved by the U.S. Food and Drug Administration for this use. If you choose to participate, you will receive the usual surgery for your kidney cancer if surgery remains appropriate. Before surgery, you will receive botensilimab and balstilimab through a vein. Treatment consists of two 6-week cycles. Botensilimab is given on Day 1 of Cycle 1 and Day 1 of Cycle 2. Balstilimab is given every 2 weeks, on Days 1, 15, and 29 of each cycle. After the first 6-week cycle, you will have imaging to assess the cancer’s response to treatment. Your study doctor will review the results with you and discuss the next steps in your care. • If the cancer has not grown, you will continue to the second cycle of study treatment. • If the cancer has grown and surgery remains appropriate, you will stop study treatment and proceed directly to surgery. • If the cancer has spread and surgery is no longer considered appropriate, you will stop study treatment, and your doctor will discuss other treatment options with you. If you complete both cycles, surgery is planned approximately 16 weeks after treatment began, provided it remains clinically appropriate. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. Additional information can be found here: https://clinicaltrials.gov/study/NCT07516366 [email protected]