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

NCT07376512 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 378

Last updated 2026-01-29

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

  • Centre Georges Francois Leclerc

    lead OTHER

Principal Investigators

  • Jessica JG GOBBO, Clinical Research Scientist · Centre Georges François Leclerc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2029-03-01
Completion
2030-03-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07376512 on ClinicalTrials.gov