Quantifying Systemic Immunosuppression to Personalize Cancer Therapy

Last updated: April 29, 2025
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Overall Status: Active - Recruiting

Phase

N/A

Condition

Renal Cell Carcinoma

Breast Cancer

Cancer

Treatment

MDSC quantification

Clinical Study ID

NCT05621837
INT 48/21
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The Serpentine (Stratify cancER PatiENTs by ImmuNosupprEssion) project, represents the most consistent effort so far attempted to translate MDSC into clinical practise by producing an off-the-shelf compliant assay for quantifying these cells in peripheral blood.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Histologically documented diagnosis of metastatic/locally advanced melanoma, hormone-refractory breast cancer, RCC and UC, SCCHN, SCC or NSCLC, stage III resectable NSCLC will also be included

  • Will and ability to comply with the protocol

  • Willingness and ability to provide an adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample available for exploratory biomarker analysis

  • Age from 18 to 90 years at the time of recruitment

  • ECOG Performance Status <= 2

  • Understanding and signature of the informed consent

  • Consenting to participate to the socio-economical-psychological survey

Exclusion Criteria

  • Known history of HIV infection

  • Serious neurological or psychiatric disorders

  • Pregnancy or lactation

  • Inability or unwillingness of participant to give written informed consent

  • Inability or unwillingness to be regularly followed up at the same center

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: MDSC quantification
Phase:
Study Start date:
March 10, 2022
Estimated Completion Date:
December 31, 2026

Study Description

The study will demonstrate that this assay helps personalizing cancer therapies by tailoring them to immune patient features. The project will also take advantage of innovative and high-throughput techniques to define additional MDSC related biomarkers and, most importantly, to identify novel drugs for Myeloid-derived Suppressor Cells (MDSC) blocking in predisposed patients. Finally,it will perform the first survey assessing the link between MDSC and "perceived social isolation", an emerging western social problem recently shown to cause myeloid cell dysfunction and immunosuppression though neuroendocrine circuits. Globally, the Serpentine proposal has the ambitious goal to translate into the clinical oncological practise the use of MDSC quantification as a tool for the systematic assessment of systemic immunosuppression, providing at the same time operational insights into the strategies to overcome this pillar mechanism of cancer progression.

Connect with a study center

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20033
    Italy

    Active - Recruiting

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