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Blood Test to Predict Benefit From Immunotherapy in Several Cancer Types

Studies a blood test of neutrophils in adults with cancer starting immunotherapy.

Key facts

Who runs it
OncoHost Ltd.
Where
Milan, ItalySee the siteAlso in 2 other countries, 2 sites
Trial code
Registry title
Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis
Status
Not yet recruiting
People taking part
600 people, planned
Started
15 Nov 2025
Expected to end
30 May 2028
Type of study
Observational, 5 groups
Treatments tested
  • Blood sample collection
Record updated
24 November 2025

Who can take part

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 newly diagnosed advanced or metastatic NSCLC, melanoma, HNSCC, RCC or TNBC who are about to start a PD-(L)1 inhibitor as first treatment. A blood sample is taken before treatment.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Newly diagnosed advanced or metastatic NSCLC, melanoma, HNSCC, RCC or TNBC.
Earlier treatment
People must be due to get a PD-(L)1 inhibitor as first-line treatment, alone or combined with other drugs. People with another active cancer that needed systemic treatment within 2 years of the first dose cannot join.
Biomarker or test result
For NSCLC, people with activating EGFR, ALK, ROS1, RET or NTRK changes linked to an approved first-line targeted drug cannot join.

Main reasons for not taking part

  • Another active cancer that needed systemic treatment within 2 years of the first dose
  • NSCLC with activating EGFR, ALK, ROS1, RET or NTRK changes linked to an approved first-line targeted drug
  • Abnormal blood counts, kidney or liver function (limits are set in the record)

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Patients newly diagnosed with advanced-stage/metastatic NSCLC, melanoma, HNSCC, RCC, or TNBC, who are due to receive first-line treatment with a PD-(L)1 inhibitor, either as monotherapy or in combination with other agents, according to current standard-of-care regimens, including (but not limited to) the following approved options: NSCLC. Monotherapy: Pembrolizumab, Atezolizumab, Cemiplimab. Combination: Pembrolizumab + chemotherapy; Nivolumab + Ipilimumab; Cemiplimab + chemotherapy; Atezolizumab + chemotherapy + Bevacizumab; Melanoma. Monotherapy: Nivolumab, Pembrolizumab. Combination: Nivolumab + Ipilimumab; Nivolumab + Relatlimab; HNSCC. Monotherapy: Pembrolizumab, Cemiplimab. Combination: Pembrolizumab + chemotherapy; RCC. Combination only: Nivolumab + Ipilimumab; Nivolumab + Cabozantinib; Pembrolizumab + Lenvatinib or Axitinib; Avelumab + Axitinib; TNBC. Combination only: Pembrolizumab + chemotherapy
  • Male or female aged at least 18 years
  • ECOG PS: 0/1-2
  • Normal hematologic, renal and liver function:; Absolute neutrophil count > 1500/mm³ Platelets > 100,000/mm³ Hemoglobin > 9 g/dL Creatinine concentration ≤ 1.4 mg/dL, or creatinine clearance > 40 mL/min, Total bilirubin < 1.5 mg/dL ALT + AST levels ≤ 3 times above the upper normal limit

Who cannot take part

  • Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of the first dose of treatment
  • For NSCLC: presence of activating EGFR, ALK, ROS1, RET, NTRK alterations linked to an approved first-line targeted drug

Where in Italy

Also in 2 other countries, 2 sites

  • Intituto Europeo di Oncologia SRLMilan, ItalyContact: Francesco BertoliniNo longer taking part

About the trial

What the trial wants to find out

The NeutroFlow study is a multi-center clinical trial designed to develop a computational model that converts flow cytometry results into a prediction of clinical benefit. The study analyzes Ly6Ehi neutrophils in biological samples from patients treated with immune checkpoint inhibitors to evaluate their likelihood of benefiting from treatment. Blood samples are collected prior to treatment and used to support the ongoing development of the algorithm.

The 5 groups in the trial

  • Patients with stage IV or stage III unresectable non-small cell lung cancer (NSCLC)

    Patients with stage IV or stage III unresectable non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors as a first-line treatment

    Treatment: Blood sample collection

  • Patients with stage IV or stage IIIb-d malignant melanoma

    Patients with stage IV or stage IIIb-d malignant melanoma treated with immune checkpoint inhibitors as a first-line treatment

    Treatment: Blood sample collection

  • Patients with stage IV head and neck squamous cell carcinoma (HNSCC)

    Patients with stage IV head and neck squamous cell carcinoma (HNSCC) treated with immune checkpoint inhibitors as a first-line treatment

    Treatment: Blood sample collection

  • Patients with stage IV renal cell carcinoma (RCC)

    Patients with stage IV renal cell carcinoma (RCC) treated with immune checkpoint inhibitors as a first-line treatment

    Treatment: Blood sample collection

  • Patients with stage IV triple-negative breast cancer (TNBC)

    Patients with stage IV triple-negative breast cancer (TNBC) treated with immune checkpoint inhibitors as a first-line treatment

    Treatment: Blood sample collection

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
NEUTROFLOW: Development and Validation of a Pan-cancer Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis of Blood Samples
Plain-language title
Blood Test to Predict Benefit From Immunotherapy in Several Cancer TypesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
24 November 2025