Status:
ACTIVE_NOT_RECRUITING
CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy
Lead Sponsor:
Hospital das Clínicas de Ribeirão Preto
Collaborating Sponsors:
Bristol-Myers Squibb
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Renal Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05215470
Start Date
January 18 2022
End Date
November 30 2026
Last Update
July 3 2024
Active Locations (1)
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1
Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto - USP
Ribeirão Preto, São Paulo, Brazil, 14040-900