NCT07246759Not yet recruiting
Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis
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
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 15 Nov 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- OncoHost Ltd.
- NCT number
- NCT07246759
What you commit to
- Study type: Observational
- Planned participants: 600
- From 15 Nov 2025 to the primary completion date, 30 Sept 2027
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of the first dose of treatment.
Lab values
- For NSCLC: presence of activating EGFR, ALK, ROS1, RET, NTRK alterations linked to an approved first-line targeted drug.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Heidelberg University Hospital Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Virgen Macarena University Hospital - Servicio Andaluz de Salud Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Intituto Europeo di Oncologia SRL Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.