New study aims to crack the code of kidney cancer treatment response

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA: * Signed Written Informed Consent * Male or female subjects aged ≥18 years old * Histologically confirmed advanced/metastatic RCC with predominantly clear-cell subtype * Previous nephrectomy is permitted * Availability of tumor tissue sample for biomarker analysis * Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC, candidate to receive first-line systemic treatment with monotherapy TKI or IO+TKI or IO+IO * No prior systemic therapy for RCC with the following exception: prior adjuvant therapy for completely resectable RCC (concluded at least 6 months before study entry) * All IMDC risk (good, intermediate, poor) * TC scan performed with and without contrast medium, at baseline (according to protocol guidelines as reported below in Table 1) * At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Eastern Cooperative Oncology Group performance status 0 or 1 * Capable of understanding and complying with the protocol requirements. EXCLUSION CRITERIA: * Any prior systemic treatment for RCC in the advanced/metastatic settings * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways * Previous exposure to tyrosine kinase inhibitors in the advanced/metastatic settings * Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis * Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of the start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low-grade prostate cancer (≤pT2, N0; Gleason 6) with no plans for treatment intervention * Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the start of treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.