Neoadjuvant Pembrolizumab and Stereotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma (NAPSTER): A Phase II Randomised Clinical Trial

Abstract

Purpose/Objective(s) In a first-in-human trial, we hypothesize that neoadjuvant SABR with or without pembrolizumab before nephrectomy will result in an immune response in the presence of an extensive reserve of tumor-associated antigens in the intact primary, resulting in better clinical outcomes Materials/Methods NAPSTER is a multi-institutional prospective, open-label, phase II, randomized, non-comparative clinical trial of adult patients with biopsy-confirmed clear-cell RCC stage T1B-T3, N0 or N1, M0 or low volume M1 planned for nephrectomy. Patients were randomized 1:1 to receive neoadjuvant SABR 42 Gy in 3 fractions to the primary RCC (Neo. SABR) or SABR and three cycles of pembrolizuma..