Radiopharmaceutical treatment of advanced kidney cancer

Prior treatment

• Patients treated previously with radiotherapy and/or surgery resulting in controlled/asymptomatic CNS disease are allowed.

Other illness

• Other malignancy that is expected to interfere with the treatment or results of this study, such as prostate cancer.

Other

• Patient with RCC in a single kidney.
• Patients with PSMA-negative lesions (defined as PSMA uptake equal to or lower than that of liver parenchyma) in any lymph node with a short axis of at least 15 mm, in any metastatic solid-organ lesions with a short axis of at least 1.0 cm, or in any metastatic bone lesion with a soft-tissue component of at least 1.0 cm in the short axis. Patients with any PSMA-negative metastatic lesion meeting these criteria were ineligible.
• Patient with active uncontrolled or symptomatic central nervous system (CNS metastases).

• Histologically proven ccRCC. Sarcomatoid component is allowed.
• Written pre-screening informed consent according to ICH/GCP and local regulations.
• Adult patients ≥18 years old.
• Has progressed on or after ≥1-line prior systemic therapy approved in the metastatic setting. Prior treatment must include an antiprogrammed death-1 (receptor) [PD-1]/programmed death-ligand 1 (PD-L1) therapy +/- ipilimumab and a VEGFR-TKI.
• Patients with at least one PSMA-positive metastatic lesion, and no exclusionary PSMA-negative lesions, with positive lesions defined as those with maximum standardized uptake values (SUVmax) greater than mean standardized uptake values (SUVmean) of liver background.
• Measurable disease by RECIST 1.1 criteria
• Patients with adequate blood tests (Absolute neutrophil count > 1.5 x 109/L, Hemoglobin > 9.0 g/dL, Platelet count > 100,000/μL, estimated glomerular filtration rate (GFR) ≥ 40 ml/min by CKDEPI formula, total bilirubin ≤ 1.5 x ULN. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases).
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Before patient 's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.