NeoAdjuvant pembrolizumab and STEreotactic radiotherapy prior to nephrectomy for renal cell carcinoma (NAPSTER): A phase II randomised clinical trial.

ABSTRACT:

Background

Surgery remains the standard of care for localised renal cell carcinoma (RCC). Nevertheless, nearly 50% of patients with high-risk disease experience relapse after surgery, with distant sites being common. Considering improved outcomes in terms of disease-free survival with adjuvant immunotherapy with pembrolizumab, we hypothesise that neoadjuvant SABR with or without the addition of pembrolizumab before nephrectomy will lead to improved disease outcomes by evoking better immune response in the presence of an extensive reserve of tumor-associated antigens.

Methods and analysis

This prospective, open-label, phase II, randomised, non-comparative, clinical trial will investigate the use of neoadjuvant stereotactic ablative body radiotherapy (SABR) with or without pem

SUBMITTER: Ali M 

PROVIDER: S-EPMC10164766 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature