Prospective Translational Study Investigating Predictors of Outcome in Metastatic Renal Cell Carcinoma Patients Treated With Nivolumab (I-Rene Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Renal Cell Carcinoma
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Investigate the predictive role of circulating miRNAs will be studied with OpenArray technology (OA, Thermo Fisher)
- Last Updated
- 4 years ago
Overview
Brief Summary
Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)
Detailed Description
Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent
- •metastatic renal cell carcinoma (a clear-cell/ not clear-cell)
- •Progression to previous treatment with tyrosine kinase inhibitors
- •Patients candidates for II-line therapy with Nivolumab (or tyrosine kinase inhibitors-in the control arm)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Investigate the predictive role of circulating miRNAs will be studied with OpenArray technology (OA, Thermo Fisher)
Time Frame: 36 months
To investigate the predictive role of circulating miRNAs in patients who respond to nivolumab versus those who do not respond before treatment, after two infusions (4 weeks), at the first radiological re-evaluation (12 weeks) and at the time of disease progression.
Characterize alterations in genes and signal transmission pathways. Using Next Generation Sequencing, NGS)
Time Frame: 36 months
o characterize alterations in genes and signaling pathways and to identify mutational burden differences between tumors of patients with metastatic renal cell carcinoma who respond or not to nivolumab.
To evaluate whether the immunological profile of tumor tissue or circulating tumor cells Using Multiplexed Biomarker Imaging (MBI), multiparametric flow cytometry
Time Frame: 36 months
To evaluate whether the immunological profile of tumor tissue or circulating tumor cells may be a potential predictor of clinical response in patients treated with nivolumab. Using Multiplexed Biomarker Imaging (MBI), multiparametric flow cytometry