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A recent phase 1 trial showed that treatment with nivolumab before surgery (neoadjuvant treatment) was tolerable in patients with high-risk clear cell renal cell carcinoma (RCC) that had not spread. These results were presented at the 21st Annual Meeting of the Society of Urologic Oncology (SUO).
The study was a phase 1 trial that looked at the safety and tolerability of nivolumab prior to surgery in patients with non-metastatic high-risk RCC. Patients with T2a-T4 RCC with or without spread to the lymph nodes were included in the study if they were scheduled to undergo a partial or radical nephrectomy, and were relatively healthy. Safety was the primary end point. Secondary end points included tumour response, quality of life, metastasis-free survival, and overall survival.
A total of 17 patients were included in the trial consisting of 16 with clear cell RCC and 1 with papillary RCC. Fifteen patients had stage T3a disease, 2 had stage T3b, and none of the patients had spread to their lymph nodes.
Severe adverse events (AEs) were reported in 11.8% of patients, and no life-threatening events were reported. AEs of any grade were reported in 82.4% of patients and were considered potentially due to nivolumab in 58.8%. The most common AEs reported were fatigue (41.2%), itchy skin (29.4%), and rash (29.4%), all mild in severity. The 2-year metastasis-free survival rate was 85.1%, and the overall survival rate was 100%. There was a small effect on the size of the tumour. Patients reported an improvement in quality-of-life, especially at 12 months after surgery.
Neoadjuvant nivolumab is currently being studied in the phase 3 PROSPER RCC study in comparison with observation for patients with RCC undergoing nephrectomy.