CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy

Renal Cancer Metastatic Clinical Trial

Official title: CLARA: Characterization of Somatic and Germline Mechanisms That Impact the Immunotherapy Treatment and Prognosis of Patients With Renal Cancer

Status Recruiting

Clinical Trial Summary

The study is studying the joint contribution and interactions of germline variants and somatic mutations and their impact on Renal Cell Carcinoma (RCC) development and treatment (immunotherapy).

Clinical Trial Description

One hundred newly diagnosticated stage IV RCC patients will be recruited in the Ribeirao Preto Medical School.

Patients will be treated with immune checkpoint inhibitors (ICI) combination: nivolumab (3 mg/kg of body weight) plus ipilimumab (1 mg/kg) intravenously every three weeks for four doses, followed by nivolumab 480mg every four weeks, until progression, toxicity or complete two years of treatment.

Patients will be followed up for the clinical outcome (progression-free survival, best response, and overall survival).

Fresh-frozen primary tumor tissue will be collected for somatic genomic characterization.

Blood DNA will be genotyped for the identification of common germline variation, as well as ancestry determination. ;

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancer Metastatic

• NCT number: NCT05215470
• Study type: Interventional
• Source: Hospital das Clínicas de Ribeirão Preto
• Contact: Leandro Machado Colli, MD, PhD
• Phone: 16991744260
• Email: leandroc@fmrp.usp.br
• Status: Recruiting
• Phase: Phase 2
• Start date: January 18, 2022
• Completion date: November 30, 2026