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New blood test aims to predict which cancer patients will benefit from immunotherapy

NCT ID NCT07246759

Diagnosis Sponsor: OncoHost Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is developing a blood test called NeutroFlow that measures specific immune cells (neutrophils) to predict whether cancer patients will benefit from immunotherapy. Researchers will collect blood samples from 600 patients with several types of cancer before they start treatment. The goal is to create a tool that helps doctors personalize cancer care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this blood test could help doctors decide which patients are most likely to benefit from immunotherapy, avoiding unnecessary treatments.
What could go wrong
This is an early-stage study to develop and validate a test, not a treatment. The test may not accurately predict outcomes for all patients or cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

At least 600 treatment-naïve patients due to be treated with a first line regimen that includes PD- 1/PD-L1 inhibitors with the following diagnoses are planned to be enrolled in the study over a period of 3 years or as needed: 1. Stage IV or Stage III-unresectable NSCLC 2. Stage IV or Stage IIIb-d malignant melanoma 3. Stage IV HNSCC 4. Stage IV RCC 5. Stage IV TNBC

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma melanoma non-small cell lung carcinoma renal cell carcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HNSCC Melanoma (skin cancer) Non-small cell lung cancer (NSCLC) RCC, renal cell cancer Triple negative breast cancer (TNBC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Heidelberg University Hospital

    Heidelberg, 69120, Germany

  • Intituto Europeo di Oncologia SRL

    Milan, 20121, Italy

  • Virgen Macarena University Hospital - Servicio Andaluz de Salud

    Seville, 41071, Spain

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