CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy
- Sponsor
- Hospital das Clínicas de Ribeirão Preto
- Study ID
- NCT05215470
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Renal Cancer Metastatic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGNivolumab 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 — DRUGIpilimumab 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 Details
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).
Key Dates
- Start date
- Jan 18, 2022
- Status verified
- Jul 2024
- Primary completion
- Nov 30, 2024
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Nivolumab+IpilimumabNivolumab 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.
Primary Outcome Measure
Overall Survival [ Time Frame: 3 years ]