Blood Test to Predict Benefit From Immunotherapy in Several Cancer Types
Studies a blood test of neutrophils in adults with cancer starting immunotherapy.
Plain-language title generated from the registry record
Registry title: Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis
Key facts
- Where
- Milan, ItalySee the site
Where in Italy
- Intituto Europeo di Oncologia SRLMilan, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- OncoHost Ltd.
- Trial code
- NCT07246759
- Record updated
- 24 November 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.