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

NCT04891055 | Unknown

• 1 other identifier: INT 71/18
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Metastatic renal cell carcinoma; Predictive factors

Outcome Measures

Primary Outcomes (3)

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

  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.

  36 months

• To evaluate whether the immunological profile of tumor tissue or circulating tumor cells Using Multiplexed Biomarker Imaging (MBI), multiparametric flow cytometry

  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

  36 months

• Characterize alterations in genes and signal transmission pathways. Using Next Generation Sequencing, NGS)

  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.

  36 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

metastatic renal cell carcinoma

You may qualify if:

• 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)

You may not qualify if:

• none

Sponsors & Collaborators

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

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Giuseppe Procopio, MD

  Fondazione IRCCS Istituto Nazionale Tumori Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Verzoni, MD

CONTACT

+390223904449; elena.verzoni@istitutotumori.mi.it

Rosanna Montone, Dr.ssa

CONTACT

+390223903817; rosanna.montone@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 18, 2021
• Study Start: November 29, 2018
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

IT (1)