CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy

• Status: Not yet recruiting
• Trial end date: 2026-11-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital das Clínicas de Ribeirão Preto
• Collaborators: Bristol-Myers Squibb; São Paulo Research Foundation (FAPESP)
• Treatments: Ipilimumab; Nivolumab

Criteria

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.