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NCT Number: NCT05621837

Quantifying Systemic Immunosuppression to Personalize Cancer Therapy

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.

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Key information

Conditions

Melanoma Adenocarcinoma Breast Cancer Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Renal Cell Carcinoma, Small Cell Carcinoma, Squamous Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Head and Neck Neoplasms Kidney Diseases Kidney Neoplasms Male Urogenital Diseases NSCLC Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Renal Cell Carcinoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Small Cell Carcinoma Squamous Cell Carcinoma of Head and Neck Urinary Bladder Cancer Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20033, Italy

Location status: Recruiting

Location contact

Licia Rivoltini, MD

CONTACT

[email protected]

+3902/23903245

Paola Frati

CONTACT

[email protected]

+3902/23903036

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MDSC quantification

Other

Blood sample will be collected at baseline and during therapy, and, optionally, in case of disease progression (PD).

Primary outcomes

  1. Immunological endpoint

    Time frame: baseline, that is prior to start the therapy (Visit_1)

    Frequency, in terms of percentage and absolute count of the defined cell subsets in whole blood and stored PBMC

  2. Immunological endpoint

    Time frame: around one month/before the time-corresponding treatment cycle (Visit_2)

    Frequency, in terms of percentage and absolute count of the defined cell subsets in whole blood and stored PBMC

  3. Immunological endpoint

    Time frame: around three months/before the time-corresponding treatment cycle (Visit_3)

    Frequency, in terms of percentage and absolute count of the defined cell subsets in whole blood and stored PBMC

  4. Immunological endpoint

    Time frame: Through study completion, an average of 2 year

    Frequency, in terms of percentage and absolute count of the defined cell subsets in whole blood and stored PBMC

  5. Clinical endpoint_PFS

    Time frame: Through study completion, an average of 2 year

    Progression-Free Survival (PFS)

  6. Clinical endpoint_OS

    Time frame: Through study completion, an average of 2 year

    Overall Survival (OS)

  7. Clinical endpoint_ORR

    Time frame: Through study completion, an average of 2 year

    Overall Response Rate (ORR)

Secondary outcomes

  1. Myeloid Index Score (MIS)

    Time frame: Through study completion, an average of 2 year

    Myeloid Index Score (MIS)=0 vs MIS>0 or higher values

  2. Index score values

    Time frame: Through study completion, an average of 2 year

    Index score values on plasma cytokine concentration or MDSC-miRs

  3. Transcriptional signatures_PBMC

    Time frame: baseline, that is prior to start the therapy (Visit_1) or at the first disease evaluation (around after three months)

    Transcriptional signatures identified on PBMC and sorted myeloid cells form whole blood

  4. Transcriptional signatures_myeloid cells

    Time frame: baseline, that is prior to start the therapy (Visit_1) or at the first disease evaluation (around after three months)

    Transcriptional signatures identified on sorted myeloid cells form whole blood

  5. Phospho-kinome signature result

    Time frame: Through study completion, an average of 2 year

    Phospho-kinome signature as assessed by Cytof analysis in stored PBMC

  6. Metabolomic profiles

    Time frame: Through study completion, an average of 2 year

    The concentration of individual metabolites or cluster of metabolites implicated in amino acid and lipid metabolism

  7. Socio-Economical-Psychological (SEP) score

    Time frame: Through study completion, an average of 2 year

    Socioeconomic and psychological (perceived social isolation) score, calculated through a dedicated questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Licia Rivoltini

CONTACT

[email protected]

+3902/23903245

Paola Frati

CONTACT

[email protected]

+3902/23903036

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Acronym: Serpentine

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2022
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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