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

Starting soon

Conditions studied: Non-Small Cell Lung Cancer, Melanoma (Skin Cancer)

In brief

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.

Key facts

Study ID

NCT07376512

Run by

Centre Georges Francois Leclerc

People needed

378

Starts

2026-03-01

Expected to finish

2030-03-01

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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