Studies blood markers in lung cancer and melanoma patients receiving immunotherapy
Checks whether blood vesicle markers relate to response to immunotherapy in lung cancer and melanoma.
Plain-language title generated from the registry record
Registry title: Predicting Response to Anti-PD-1/PD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis
Key facts
- Where
- Besançon, Dijon, and Lyon, FranceSee the 5 sites
Where in France
- CHU Besançon - Service DermatologieBesançon, FranceNot yet recruiting
- CHU Besançon - Service Pneumologie Oncologie ThoraciqueBesançon, FranceNot yet recruiting
- Centre Georges François LeclercDijon, FranceTaking people
- CHU Dijon - Service Oncologie MédicaleDijon, FranceTaking people
- Centre Leon Berard - Service Oncologie MédicaleLyon, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Georges Francois Leclerc
- Trial code
- NCT07376512
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
Predicting Response to Anti-PD-1/PD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis
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.
Inclusion: 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: Prior treatment with immunotherapy; Treatment with systemic immunosuppressants, including within 28 days prior to enrollment, or corticosteroids >10 mg/day, including within 14 days prior to enrollment; Presence of another synchronous malignancy; Disease not measurable according to RECIST 1.1 criteria; Positive serology for HIV, HBV, or HCV; Presence of EGFR or ALK mutation (applicable only to the lung cohort); Diagnosis of uveal melanoma; 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).