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Not yet recruitingNCT07376512EVpredictUpdated Jan 29, 2026

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

An observational study in Non-Small Cell Lung Cancer and Melanoma (Skin Cancer), sponsored by Centre Georges Francois Leclerc. Not yet recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Centre Georges Francois Leclerc · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
378
Ages
18 Years and older
Sex
All
01

Study summary

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.
Read the 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.
02

Conditions studied

  • Non-Small Cell Lung Cancer
  • Melanoma (Skin Cancer)

Keywords

  • standard treatment with anti-PD-(L)1 monotherapy or combination therapy
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 378 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Centre Georges Francois Leclerc is the lead sponsor of 75 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
378 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Target protein levels in plasma-derived extracellular vesicles (EVs) measured by multiplex ELISA before treatment

    Treatment response assessed as Best Overall Response (BOR: complete or partial response per RECIST 1.1) within 6 months.

    Time frame: 6 months from treatment initiation

07

Study locations

5 sites
  • CHU Besançon - Service Dermatologie
    Besançon, 25000, France
  • CHU Besançon - Service Pneumologie Oncologie Thoracique
    Besançon, 25000, France
  • Centre Georges-François Leclerc
    Dijon, 21000, France
  • CHU Dijon - Service Oncologie Médicale
    Dijon, 21000, France
  • Centre Leon Berard - Service Oncologie Médicale
    Lyon, 69000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07376512
Lead sponsor
Centre Georges Francois Leclerc
Responsible party
Sponsor
First posted
Jan 29, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Mar 1, 2029 (estimated)
Completion
Mar 1, 2030 (estimated)
Last update
Jan 29, 2026

Study contacts

Courèche CK KADERBHAI, Doctor
Contact
cgkaderbhai@cgfl.fr
03 80 73 75 28 ext. +33
Anne-Laure ALR REROLE, Project manager
Contact
arerole@cgfl.fr
03 45 34 88 46 ext. +33
Jessica JG GOBBO, Clinical Research Scientist
study chair · Centre Georges François Leclerc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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