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Patients with locally advanced renal cell carcinoma undergoing curative-intent nephrectomy remain at risk for systemic failure. Studies testing first-generation immunotherapy agents and a variety of tyrosine kinase inhibitors (TKIs) failed to demonstrate benefit, and routine practice is to manage patients expectantly with surveillance imaging. Next-generation immunotherapy agents either in combination or with the addition of TKIs are now the standard of care for metastatic clear-cell disease.
This manufacturer-designed and -conducted phase 3 adjuvant study randomized patients with histologically confirmed renal-cell carcinoma with a clear-cell component at high risk for recurrence to receive 1 year of adjuvant pembrolizumab or placebo. The p…