Quantifying Systemic Immunosuppression to Personalize Cancer Therapy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Contact Information
Primary
Licia Rivoltini
licia.rivoltini@istitutotumori.mi.it
+3902/23903245
Backup
Paola Frati
paola.frati@gmail.com
+3902/23903036
Time Frame
Start Date: 2022-03-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1000
Treatments
Metastatic melanoma patients
MDSC quantification in Metastatic melanoma patients undergoing first/second-line treatment with BRAF and MEK inhibitors (BRAFi+MEKi) or immune checkpoint inhibitors (antagonists of PD-1 or CTL4, or both) (n=100);
hormone receptor positive/Human Epidermal growth factor Receptor-2 negative cancer patients
MDSC quantification in Metastatic HR+(hormone receptor positive)/ HER2-(Human Epidermal growth factor Receptor-2 negative) breast cancer patients already treated with a combination of an hormonal agent and a CDK(Cyclin-dependent kinase)4/6 inhibitor and receiving chemotherapy (n=100);
Advanced RCC(renal cell carcinoma) patients
MDSC quantification Advanced RCC patients receiving immune checkpoint inhibitors (antagonists of PD-1, PD-L1 or CTL4, or combinations) or anti-angiogenics alone or combined with immune checkpoint inhibitors; locally advanced/metastatic UC(Urothelial Carcinoma) patients receiving first-line chemotherapy, immune checkpoint inhibitors or combinations (n=100);
SCCHN or SCC(Small Cell Carcinoma) patients
MDSC quantification in SCCHN or SCC(Small Cell Carcinoma) patients treated with first-line chemotherapy, cetuximab,immune checkpoint inhibitors or combinations (n=100).
NSCLC patients
MDSC quantification in NSCLC patients undergoing radical surgery for stage III cancer (n=100);patients with unresectable/metastatic NSCLC receiving first line treatment with chemotherapy, immune checkpoint inhibitors (antagonists of PD-1, PD-L1 or CTL4) or combinations (n=100).
Age and gender-matched healthy donors
Age and gender-matched healthy donors (n=400) will be enrolled in the study, to allow us investigating the same immunological parameters under physiological conditions and define normal values for the myeloid-related biomarkers here assessed.
Related Therapeutic Areas
Breast Cancer
Melanoma
Head and Neck Squamous Cell Carcinoma (HNSCC)
Renal Cell Carcinoma (RCC)
Bladder Cancer
Sponsors
Leads: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients With Muscle-invasive Bladder Cancer With Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients With Muscle-invasive Bladder Cancer With Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

Who is this study for: Adult patients with Muscle-Invasive Urothelial Carcinoma of the Bladder with no prior radiation therapy
Enrollment Status: Recruiting
Publish Date: October 08, 2025
Intervention Type: Procedure, Drug, Biological, Other
Study Drugs: Gemcitabine, Cisplatin, Pegfilgrastim
Study Phase: Phase 2

A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® Bladder Cancer Test in the Urine DNA for Detecting Bladder Cancer Among Hematuria Patients

A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® Bladder Cancer Test in the Urine DNA for Detecting Bladder Cancer Among Hematuria Patients

Enrollment Status: Recruiting
Publish Date: October 04, 2023
Intervention Type: Diagnostic test

A Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

A Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

Who is this study for: Patients with metastatic urothelial carcinoma refractory to, or ineligible for, anti PD1/PDL1 therapy
Enrollment Status: Recruiting
Publish Date: October 15, 2025
Intervention Type: Procedure, Drug, Biological
Study Drugs: Docetaxel, Eribulin Mesylate, Gemcitabine Hydrochloride, Paclitaxel
Study Phase: Phase 3
View All