Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis (NEUTROFLOW)

OncoHost

Status

Not yet enrolling

Conditions

RCC, Renal Cell Cancer

Triple Negative Breast Cancer (TNBC)

HNSCC

Melanoma (Skin Cancer)

Non Small Cell Lung Cancer (NSCLC)

Treatments

Other: Blood sample collection

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT07246759

NEUTROFLOW

Details and patient eligibility

About

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.

Full description

The recent introduction of cancer immunotherapy based on immune checkpoint inhibitors (ICIs) has revolutionised the treatment landscape for a broad range of cancer types. However, response to ICIs varies widely between patients, with the majority experiencing resistance to therapy. Moreover, the increasing use of these costly drugs coupled with management of ICI-related toxicities creates a substantial economic burden. Current biomarker tests for determining eligibility for ICIs have limited predictive performance, and many require invasive tumour biopsies. Thus, novel (and preferentially non-invasive) biomarkers for predicting ICI clinical benefit are desperately needed for better guiding clinical decisions. NeutroFlow directly addresses this unmet need. The neutroFlow study is based on a comprehensive academic research describing a flow cytometry assay for measuring a novel predictive biomarker in the blood - Ly6Ehi neutrophil - that accurately predicts therapeutic benefit from ICIs, outperforming the approved PD-L1 biomarker.

The objective of the NeutroFlow study is to develop a clinical decision-support tool that includes an antibody panel for detecting Ly6Ehi neutrophils using standard flow cytometry (FC) and a computational model that converts the FC readout into a prediction of clinical benefit.

Patients will provide a single blood sample before starting treatment, and clinical data will be collected from their medical records.

In the first phase of the trial, blood sample data and clinical information will be used to develop the antibody panel and train the prediction algorithm. In the second phase, the algorithm will be validated by comparing its theoretical predictions with the patients' actual objective response rates.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

600 participants in 5 patient groups

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

Description:

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:

Other: Blood sample collection

Patients with stage IV or stage IIIb-d malignant melanoma

Description:

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

Treatment:

Other: Blood sample collection

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

Description:

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

Treatment:

Other: Blood sample collection