Prospective Translational Study Investigating Predictors of Outcome in Metastatic Renal Cell Carcinoma Patients Treated With Nivolumab (I-Rene Trial)

• Conditions: Metastatic Renal Cell Carcinoma

• Registration Number: NCT04891055
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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)

Study Timeline

• Study Start: 2018-11-29
• Status Verified: 2021-05
• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-12
• Last Update Submitted: 2021-05-12
• Study First Posted: 2021-05-18
• Last Update Posted: 2021-05-18
• Primary Completion: 2021-11-29
• Study Completion: 2021-11-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigate the predictive role of circulating miRNAs will be studied with OpenArray technology (OA, Thermo Fisher)	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)	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	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

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale Tumori; 🇮🇹 Milano, Italy