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

NCT07376512 · tracked via the Priya Life Science France tracker

Sponsor

Centre Georges Francois Leclerc

Phase

Observational

Started

2026-03-01

Last updated

2026-01-29

Condition(s) studied

Non-Small Cell Lung CancerMelanoma (Skin Cancer)

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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).

Primary outcome measure(s)

Target protein levels in plasma-derived extracellular vesicles (EVs) measured by multiplex ELISA before treatment — 6 months from treatment initiation
Treatment response assessed as Best Overall Response (BOR: complete or partial response per RECIST 1.1) within 6 months.

Trial sites (5)

Facility	City	Region
CHU Besançon - Service Dermatologie	Besançon	France
CHU Besançon - Service Pneumologie Oncologie Thoracique	Besançon	France
Centre Georges-François Leclerc	Dijon	France
CHU Dijon - Service Oncologie Médicale	Dijon	France
Centre Leon Berard - Service Oncologie Médicale	Lyon	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07376512 on ClinicalTrials.gov ↗ ← All trials in France