NCT05215470

CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hospital das Clínicas de Ribeirão Preto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab is called an anti-PD-1 (Programmed Cell Death Ligand 1) or a checkpoint inhibitor and is an antibody (a type of human protein) designed to allow the body's own immune system to destroy tumors
DRUG	Ipilimumab	Ipilimumab is called an anti-CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) and is a type of antibody that works to prevent the body's immune system from stopping to fight a specific cancer

Timeline

• Start date: 2022-01-18
• Primary completion: 2024-11-30
• Completion: 2026-11-30
• First posted: 2022-01-31
• Last updated: 2024-07-03

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study