NCT07376512Recruiting
Predicting Response to Anti-PD-1/PD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 378 (estimated)
- First submitted
- 22 Jan 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Nov 2030
- Lead sponsor
- Centre Georges Francois Leclerc
- Diseases
- Melanoma, Lung cancer
- NCT number
- NCT07376512
What you commit to
- Study type: Observational
- Planned participants: 378
- From 1 Nov 2026 to the primary completion date, 1 Nov 2030
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Presence of another synchronous malignancy.
- Disease not measurable according to RECIST 1.1 criteria.
- Positive serology for HIV, HBV, or HCV.
Lab values
- Presence of EGFR or ALK mutation (applicable only to the lung cohort).
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Besançon - Service Pneumologie Oncologie Thoracique Coordinator of this site? Confirm its status | Besançon | France | Not yet recruiting |
| CHU Besançon - Service Dermatologie Coordinator of this site? Confirm its status | Besançon | France | Not yet recruiting |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| CHU Dijon - Service Oncologie Médicale Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Leon Berard - Service Oncologie Médicale Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.