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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
• 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 Criteria:
* 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.
Primary outcome measure(s)
Quantification of Ly6E high (Ly6Ehi) neutrophils in blood using the NeutroFlow flow cytometry assay — Baseline (up to 1 month before treatment initiation) Peripheral blood samples will be collected from patients up to 1 month prior to treatment initiation. Ly6Ehi neutrophil populations will be quantified using the NeutroFlow multiparametric flow cytometry assay
Prediction of clinical benefit rate using baseline Ly6Ehi neutrophils levels — Baseline (blood draw) to 6, 12, 18, and 24 months post treatment initiation The patients clinical benefit (CB) will be defined according to RECIST 1.1 criteria to one of the following categories: complete response (CR), partial response (PR), or stable disease (SD). Baseline Ly6Ehi neutrophil levels will be used as input in a computational predictive model to estimate the likelihood of CB for each patient. The model will be trained and validated with independent patient cohorts, using cross-validation and ROC AUC metrics to assess predictive performance. Sensitivity, specificity, positive predictive value, and negative predictive value will also be calculated. Predictions will be assessed at multiple timepoints: 6, 12, 18, and 24 months post-initiation of anti-PD-(L)1 therapy. Subgroup analyses will include age, sex, cancer type, disease stage, and treatment line.
Trial sites (3)
Facility
City
Region
Status
Heidelberg University Hospital
Heidelberg
Germany
Intituto Europeo di Oncologia SRL
Milan
Italy
Virgen Macarena University Hospital - Servicio Andaluz de Salud
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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