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NEUTROFLOWNeutrophil Biomarker Test for Predicting Immunotherapy Benefit in Cancer Patients

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Study Aim

This study aims to observe how levels of specific neutrophils in your blood can predict the effectiveness of immunotherapy in cancer patients.

What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Squamous Cell Carcinoma of Head and Neck+36

+ Urogenital Diseases

+ Adenocarcinoma

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 2025
See protocol details

Summary

Principal SponsorOncoHost Ltd.
Study ContactMichal Harel VP of Translational Medicine, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 15, 2025

Actual date on which the first participant was enrolled.

This study focuses on improving the way doctors predict if cancer patients will benefit from a type of treatment called immunotherapy. Immunotherapy has changed how many cancers are treated, but it doesn't work for everyone. Currently, the tests used to decide if a patient should receive immunotherapy aren't always accurate and can require painful procedures. The NeutroFlow study aims to develop a new, more accurate, and less invasive test using blood samples to find a specific type of immune cell called Ly6Ehi neutrophils. This could help doctors make better treatment decisions, reduce unnecessary treatments, and lower healthcare costs by avoiding expensive drugs that might not work. In this study, participants will provide a blood sample before they start their treatment. Researchers will use a technology called flow cytometry to look for Ly6Ehi neutrophils in the blood. The information from these tests will be used to create a tool that predicts how well the patient will respond to the treatment. This tool will be validated by comparing its predictions with the actual outcomes of the patients' treatments over time. The study will also analyze how well the test works for different groups of people based on factors like age, gender, and cancer type, aiming to ensure it is effective for a wide range of patients.

Official TitleNEUTROFLOW: Development and Validation of a Pan-cancer Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis of Blood Samples
Principal SponsorOncoHost Ltd.
Study ContactMichal Harel VP of Translational Medicine, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Squamous Cell Carcinoma of Head and NeckUrogenital DiseasesAdenocarcinomaBreast DiseasesBreast NeoplasmsBronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellCarcinoma, Squamous CellFemale Urogenital Diseases and Pregnancy ComplicationsHead and Neck NeoplasmsKidney DiseasesKidney NeoplasmsLung DiseasesLung NeoplasmsMelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRespiratory Tract DiseasesRespiratory Tract NeoplasmsSkin DiseasesSkin NeoplasmsThoracic NeoplasmsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine TumorsFemale Urogenital DiseasesMale Urogenital DiseasesTriple Negative Breast Neoplasms

Criteria

9 inclusion criteria required to participate
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.

Show More Criteria

2 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Heidelberg University Hospital

Heidelberg, GermanyOpen Heidelberg University Hospital in Google Maps
Suspended

Intituto Europeo di Oncologia SRL

Milan, Italy
Suspended

Virgen Macarena University Hospital - Servicio Andaluz de Salud

Seville, Spain
Recruiting soon3 Study Centers