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NOT YET RECRUITING
NCT07376512

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

Sponsor: Centre Georges Francois Leclerc

View on ClinicalTrials.gov

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