Clinical Trial: Translational Research of the FIRST-RCC Study: A Multicenter Retrospective Study on the Efficacy and Safety of First-Line Treatment with Nivolumab plus Cabozantinib or Pembrolizumab plus Lenvatinib for Advanced or Metastatic Renal Cell Carcinoma (Japan)

Tokyo, Sept. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062879) titled 'Translational Research of the FIRST-RCC Study: A Multicenter Retrospective Study on the Efficacy and Safety of First-Line Treatment with Nivolumab plus Cabozantinib or Pembrolizumab plus Lenvatinib for Advanced or Metastatic Renal Cell Carcinoma' on Sept. 10.

Study Type: Observational

Primary Sponsor: Institute - Yokohama City University

Condition: Condition - Kidney cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - The FIRST-RCC study is a multicenter retrospective observational study evaluating the efficacy and safety of first-line treatment with nivolumab plus cabozantinib or pembrolizumab plus lenvatinib in patients with advanced or metastatic renal cell carcinoma. This translational research study aims to perform comprehensive gene expression profiling of renal cell carcinoma tissues from patients eligible for the FIRST-RCC study and to investigate the associations between gene expression-based molecular subtypes and clinical outcomes of each first-line treatment, as well as other clinical characteristics. Basic objectives2 - Bio-availability

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients eligible for the FIRST-RCC study with available pathological specimens of renal cell carcinoma for this translational research study. Key exclusion criteria - Patients eligible for the FIRST-RCC study who decline participation in this translational research study through the informed consent or opt-out process. Target Size - 400

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 21 Day Anticipated trial start date - 2026 Year 08 Month 21 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071992

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