Predicting who responds to anti-PD-1/PD-L1 therapy using blood extracellular vesicle tests

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective multicenter observational study enrolling adults with locally advanced or metastatic NSCLC or unresectable melanoma who are starting anti-PD-(L)1 therapy. Blood samples will be collected at four time points, alongside routine care data such as imaging and tumor genotyping, to analyze EV-associated immune biomarkers. The goal is to see if baseline EV biomarkers correlate with treatment response and how they change over time, and to develop a preliminary immune signature to predict response or resistance. Analyses will be stratified by tumor type to explore whether NSCLC and melanoma differ in predictive performance. No new interventions are tested beyond standard-of-care treatment and sample collection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Centre Georges-François Leclerc
  Dijon, France Recruiting
• CHU Dijon - Service Oncologie Médicale
  Dijon, France Recruiting
• CHU Besançon - Service Dermatologie
  Besançon, France Not yet recruiting
• CHU Besançon - Service Pneumologie Oncologie Thoracique
  Besançon, France Not yet recruiting
• Centre Leon Berard - Service Oncologie Médicale
  Lyon, France Not yet recruiting

Study contacts

• Study coordinator: Courèche CK KADERBHAI, Doctor
• Email: cgkaderbhai@cgfl.fr
• Phone: 03 80 73 75 28

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.