Quantifying Systemic Immunosuppression to Personalize Cancer Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Primary outcome measure(s)

• Immunological endpoint — 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
• Immunological endpoint — 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
• Immunological endpoint — 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
• Immunological endpoint — 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
• Clinical endpoint_PFS — Through study completion, an average of 2 year
  Progression-Free Survival (PFS)
• Clinical endpoint_OS — Through study completion, an average of 2 year
  Overall Survival (OS)
• Clinical endpoint_ORR — Through study completion, an average of 2 year
  Overall Response Rate (ORR)

Trial sites (1)

More Fondazione IRCCS Istituto Nazionale dei Tumori, Milano trials in Italy

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