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
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
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Renal cell carcinoma patient: histological confirmed clear cell tumor;
* First-line metastatic treatment;
* Stage IV with at least one measured lesion;
* Fresh-frozen primary tumor tissue available;
* No previous immunotherapy or tyrosine kinase inhibitor treatment;
* All International Metastatic RCC Database Consortium (IMDC) Risk Score;
* Karnofsky Performance Scale (KPS) \>=70;
* \>=18 years old.
Exclusion Criteria:
* History of a known or suspected autoimmune disease;
* Any condition requiring systemic treatment with corticosteroids;
* Creatinine clearance \< 40mL/min;
* Alanine aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) \> 5 x ULN;
* Pregnant women.
Primary outcome measure(s)
Overall Survival — 3 years
Progression-free survival — 2 years
Trial sites (1)
Facility
City
Region
Status
Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto - USP
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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