Patients
tumours, tumour, Tumors
TUMOURS, DISEASE, METASTATIC DISEASE, TUMORS, TUMOUR, ONCOLOGY, AUTOIMMUNE DISEASE
Eligible patients were aged ≥18 years with previously untreated locally advanced ccRCC without evidence of metastatic disease. All patients underwent an initial diagnostic biopsy of their renal lesion to confirm clear cell histology. Eligible patients had clinical stage cT2-T3b, N0, M0 tumours, with retroperitoneal lymph nodes ≤1 cm in size (considered clinical N0) and were candidates for partial or radical nephrectomy. Additional key inclusion criteria were measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 and an Eastern Cooperative Oncology Group performance status score of 0 or 1. Key exclusion criteria included inability to undergo a baseline tumour biopsy; a clinical status indicating the need for immediate (within 6 weeks) surgery, regardless of whether neoadjuvant therapy was to be administered; autoimmune disease; or any current/prior use of an immunosuppressant (>10 mg daily prednisone equivalent). The full trial protocol is available in the supplementary note.