Spots Global Cancer Trial Database for CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy

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

Study ID: NCT05215470

Conditions

Renal Cancer Metastatic

Interventions

Nivolumab

Ipilimumab

Study Description

Brief 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).

Detailed 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.