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
- Heidelberg, GermanySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed advanced or metastatic NSCLC, melanoma, HNSCC, RCC or TNBC who are about to start a PD-(L)1 inhibitor as first treatment. A blood sample is taken before treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed advanced or metastatic NSCLC, melanoma, HNSCC, RCC or TNBC.
- Earlier treatment
- People must be due to get a PD-(L)1 inhibitor as first-line treatment, alone or combined with other drugs. People with another active cancer that needed systemic treatment within 2 years of the first dose cannot join.
- Biomarker or test result
- For NSCLC, people with activating EGFR, ALK, ROS1, RET or NTRK changes linked to an approved first-line targeted drug cannot join.
Main reasons for not taking part
- Another active cancer that needed systemic treatment within 2 years of the first dose
- NSCLC with activating EGFR, ALK, ROS1, RET or NTRK changes linked to an approved first-line targeted drug
- Abnormal blood counts, kidney or liver function (limits are set in the record)
Read by machine on 9 November 2026.
Where in Germany
- Heidelberg University HospitalHeidelberg, GermanyNo 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.