Nivolumab with Surgery for Kidney Cancer

(PROSPER Trial)

This trial tests whether adding the drug nivolumab (Opdivo) to kidney surgery can better prevent cancer recurrence compared to surgery alone. Nivolumab may help the immune system target any remaining cancer cells after the removal of the kidney or part of it. The trial is open to individuals with kidney cancer that hasn't spread extensively and who haven't received treatment for their current cancer. Participants will either receive nivolumab with their surgery or undergo surgery alone and be monitored. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

The trial does not specify if you need to stop taking your current medications. However, you must not be on any systemic treatment with corticosteroids or other immunosuppressive medications, except for certain exceptions like topical or inhaled steroids. It's best to discuss your current medications with the trial team.

Research has shown that nivolumab, when combined with kidney removal surgery, is generally safe for patients with kidney cancer. However, some side effects require attention. A small number of patients experienced serious reactions, such as sudden kidney problems, lung infections, and diarrhea.

Researchers are excited about the use of nivolumab combined with nephrectomy for kidney cancer because it introduces a powerful immune-based approach to treatment. Unlike traditional methods that rely solely on surgery or targeted therapies, nivolumab is an immunotherapy that works by blocking the PD-1 pathway, effectively "releasing the brakes" on the immune system to help it attack cancer cells more effectively. This combination has the potential to enhance the body's natural defenses against cancer while still utilizing the proven benefits of surgery. Additionally, the treatment regimen is designed to maintain effectiveness over a longer period with fewer cycles, potentially reducing side effects and improving patient quality of life.

Research has shown that nivolumab, one of the treatments in this trial, may help treat kidney cancer when combined with kidney surgery. In this trial, some participants will receive nivolumab alongside nephrectomy. Studies have found that patients with advanced kidney cancer who received nivolumab and another drug had a significantly lower risk of death compared to those on other treatments. In some studies, the risk of death was reduced by 28%. Nivolumab helps the immune system find and attack cancer cells, suggesting that adding nivolumab to surgery might help prevent the cancer from returning.³⁴⁶⁷⁸