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Studies

Observational Recruiting

NCT07376512 on ClinicalTrials.gov

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

  • Sponsor: Centre Georges François Leclerc
  • Enrollment: 378 (Estimated)
  • Study start: 2026-11-01 (Estimated)
  • Primary completion: 2030-11-01 (Estimated)
  • Study completion: 2030-11-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief 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.

Conditions

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

Primary Outcome Measures

  • 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.

Countries

France

Locations and Investigators

  • CHU Besançon - Service Dermatologie, Besançon, France (Not yet recruiting)
    • Charlée CN NARDIN, Doctor
  • CHU Besançon - Service Pneumologie Oncologie Thoracique, Besançon, France (Not yet recruiting)
    • Guillaume GE EBERST, Doctor
  • Centre Georges-François Leclerc, Dijon, France (Recruiting)
    • Courèche CK KADERBHAI, Doctor
  • CHU Dijon - Service Oncologie Médicale, Dijon, France (Recruiting)
    • Ayoube AZ ZOUAK, Doctor
  • Centre Leon Berard - Service Oncologie Médicale, Lyon, France (Not yet recruiting)
    • Mona MA AMINI-ADLE, Doctor

Study Officials