Measuring Immune-Suppressing Cells in Blood of People With Cancer

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or metastatic cancer of certain types, such as melanoma, breast, kidney, bladder, head and neck, or lung cancer. A blood test will measure immune-suppressing cells.

Age

18 to 90 years

Sex

All sexes can join.

Disease stage

Metastatic or locally advanced melanoma, hormone-refractory breast cancer, RCC, UC, SCCHN, SCC or NSCLC. Stage III resectable NSCLC can also join.

Biomarker or test result

An archival tumor sample (FFPE) must be available for biomarker tests.

Main reasons for not taking part

• Known history of HIV infection
• Serious neurological or psychiatric disorders
• Pregnancy or breastfeeding
• Cannot or will not give written informed consent
• Cannot or will not be followed up regularly at the same center

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 90 years old?YesNo

What the trial wants to find out

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.

The 6 groups in the trial

• 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);

  Treatment: MDSC quantification

• 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);

  Treatment: MDSC quantification

• 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);

  Treatment: MDSC quantification

• 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).

  Treatment: MDSC quantification

• 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).

  Treatment: MDSC quantification

• 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.

  Treatment: MDSC quantification