A Phase 2 interventional study of Nivolumab and Ipilimumab in Renal Cancer Metastatic, sponsored by Hospital das Clínicas de Ribeirão Preto. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Hospital das Clínicas de Ribeirão Preto · Phase 2, Interventional, and Treatment
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).
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.
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's planned enrollment of 100 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →Hospital das Clínicas de Ribeirão Preto is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nivolumab IV 3mg/kg 3/3w + Ipilimumab 1mg/kg 3/3w 4 doses, followed by Nivolumab IV 480mg 4/4w until progression, toxicity, or up to 2 years of use.
Drug: Nivolumab · Drug: Ipilimumab
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
Also known as: Opdivo
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
Also known as: Yervoy
Overall Survival
Time frame: 3 years
Progression-free survival
Time frame: 2 years
Overall Response Rate
Time frame: 2 years
Plan to share: Yes — The research team is committed to sharing data generated by this project with the research community. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Hospital das Clínicas de Ribeirão Preto