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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04891055

Acronym

I-Rene

Enrollment

Registered

2021-05-18

Start date

2018-11-29

Completion date

2021-11-29

Last updated

2021-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Metastatic renal cell carcinoma, Predictive factors

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)

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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
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.

Countries

Italy

Contacts

Primary ContactElena Verzoni, MD

elena.verzoni@istitutotumori.mi.it+390223904449

Backup ContactRosanna Montone, Dr.ssa

rosanna.montone@istitutotumori.mi.it+390223903817

Outcome results