Predicting Response to Anti-PD-1/PD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis (EVpredict)

January 22, 2026 updated by: Centre Georges Francois Leclerc

The objective of this prospective multicenter study is to evaluate whether the analysis of immunological biomarkers present in circulating extracellular vesicles is associated with the response to anti-PD-1/PD-L1 treatments in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or unresectable melanoma.

Patients will receive standard-of-care treatment and will be followed according to routine clinical practice. The study involves the collection of four study-specific blood samples at different time points during follow-up, as well as the collection of standard immunohistochemistry results, thoraco-abdomino-pelvic CT scans, and tumor DNA genotyping analyses performed as part of routine care.

The study aims to determine:

  • whether baseline biomarkers in extracellular vesicles are associated with response to anti-PD-1/PD-L1 treatment,
  • how these biomarkers change over the course of treatment, and
  • to provide exploratory data for the development of predictive immunological response signatures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Immune checkpoint inhibitors (anti-PD-1/PD-L1) have become standard treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) or melanoma. However, not all patients respond to these therapies, and current biomarkers are imperfect.

Circulating extracellular vesicles (EVs) are nanovesicles derived from tumor and immune cells, carrying proteins, nucleic acids, and lipids. They represent an accessible and stable source of immunological biomarkers, allowing monitoring of the tumor microenvironment without additional invasive procedures.

This prospective multicenter study aims to:

  • Collect and analyze immunological biomarkers present in EVs at baseline and during follow-up.
  • Assess their association with objective response to anti-PD-1/PD-L1 treatment, measured according to RECIST 1.1.
  • Develop an exploratory composite score combining multiple markers to predict response, stratified by cancer type (NSCLC vs melanoma).
  • Prospectively collect biological samples for future exploratory analyses.

Study procedures for participants include:

  • Blood sample collection: Four study-specific blood draws performed during standard treatment or tumor assessment visits (baseline, 2nd administration, first evaluation, second evaluation).
  • Collection of additional information: Standard immunohistochemistry results for PD-1, PD-L1, CTLA-4, Tim-3, LAG-3, and Tigit; thoraco-abdomino-pelvic CT scans; circulating or tumor DNA genotyping analyses.
  • Clinical follow-up: Conducted according to routine care standards, with no changes to treatment or additional study-specific visits.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
378

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Courèche CK KADERBHAI, Doctor
  • Phone Number: +33 03 80 73 75 28
  • Email: cgkaderbhai@cgfl.fr

Study Contact Backup

  • Name: Anne-Laure ALR REROLE, Project manager
  • Phone Number: +33 03 45 34 88 46
  • Email: arerole@cgfl.fr

Study Locations

  • France
      • Besançon, France, 25000
        • CHU Besançon - Service Dermatologie
        • Contact:
      • Besançon, France, 25000
        • CHU Besançon - Service Pneumologie Oncologie Thoracique
        • Contact:
      • Dijon, France, 21000
        • Centre Georges-Francois Leclerc
        • Contact:
      • Dijon, France, 21000
        • CHU Dijon - Service Oncologie Médicale
        • Contact:
      • Lyon, France, 69000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with non-small cell lung cancer (NSCLC) or melanoma, locally advanced or metastatic, and unresectable. For all patients, first-line standard treatment will be based on standard care with an anti-PD-(L)1 therapy, either as monotherapy or in combination (with other immune checkpoint inhibitors or chemotherapy). Standard treatments are defined by the approved indications (marketing authorizations) in France.

Description

Inclusion Criteria:

  • Age ≥18 years.
  • Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) or locally advanced/metastatic unresectable melanoma.
  • Patient scheduled to initiate anti-PD-(L)1 therapy, either as monotherapy or in combination (other immune checkpoint inhibitors, chemotherapy, etc.).
  • Baseline tumor assessment performed within 28 days prior to enrollment (CT scan of thorax, abdomen, and pelvis) with at least one measurable lesion according to RECIST 1.1 criteria.
  • Life expectancy >6 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at enrollment.
  • Patient able to provide informed consent and comply with study procedures.
  • Patient covered by a social security system or equivalent.

Exclusion Criteria:

  • Prior treatment with immunotherapy.
  • Presence of EGFR or ALK mutation (applicable only to the lung cohort).
  • Presence of another synchronous malignancy.
  • Diagnosis of uveal melanoma.
  • Treatment with systemic immunosuppressants, including within 28 days prior to enrollment, or corticosteroids >10 mg/day, including within 14 days prior to enrollment.
  • Disease not measurable according to RECIST 1.1 criteria.
  • Positive serology for HIV, HBV, or HCV.
  • Pregnant or breastfeeding women.
  • Inability to comply with study follow-up and visits for geographic, social, or psychological reasons.
  • Individuals deprived of liberty or under legal guardianship (including curatorship).

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Advanced NSCLC or Melanoma - Anti-PD-(L)1 Therapy

This cohort includes patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or inoperable melanoma who are receiving standard-of-care anti-PD-1 or anti-PD-L1 therapy, either as monotherapy or in combination with other approved therapies.

Participants will follow standard clinical management, and study-specific procedures include four blood draws for extracellular vesicle (EV) analysis at baseline and during follow-up, collection of standard immunohistochemistry results (PD-1, PD-L1, CTLA-4, Tim-3, LAG-3, TIGIT), thoraco-abdominopelvic CT imaging, and tumor DNA genotyping performed as part of routine care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Target protein levels in plasma-derived extracellular vesicles (EVs) measured by multiplex ELISA before treatment
Time Frame: 6 months from treatment initiation
Treatment response assessed as Best Overall Response (BOR: complete or partial response per RECIST 1.1) within 6 months.
6 months from treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Georges Francois Leclerc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jessica JG GOBBO, Clinical Research Scientist, Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-A01783-46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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