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

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Other)
Overall Status
Recruiting
CT.gov ID
NCT04891055
Collaborator
Ministero della Salute, Italy (Other)
90
Enrollment
1
Location
36
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Prospective Translational Study Investigating Predictors of Outcome in Metastatic Renal Cell Carcinoma Patients Treated With Nivolumab (I-Rene Trial)
    Actual Study Start Date :
    Nov 29, 2018
    Anticipated Primary Completion Date :
    Nov 29, 2021
    Anticipated Study Completion Date :
    Nov 29, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    patients treated with nivolumab

    Patients candidates for II line therapy with Nivolumab from clinical practice
    patients treated with TKI

    Patients candidates for II line therapy with TKI from clinical practice

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione IRCCS Istituto Nazionale Tumori Milano Italy 20133

    Sponsors and Collaborators

    • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    • Ministero della Salute, Italy

    Investigators

    • Principal Investigator: Giuseppe Procopio, MD, Fondazione IRCCS Istituto Nazionale Tumori Milano

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    ClinicalTrials.gov Identifier:
    NCT04891055
    Other Study ID Numbers:
    • INT 71/18
    First Posted:
    May 18, 2021
    Last Update Posted:
    May 18, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    Metastatic renal cell carcinoma
    Predictive factors
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of May 18, 2021