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Predicting Response to Anti-PD-1/PD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis
Sponsor: Centre Georges Francois Leclerc
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
378
Start Date
2026-03-01
Completion Date
2030-03-01
Last Updated
2026-01-29
Healthy Volunteers
No
Locations (5)
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