Predicting Response to Anti-PD-1/PD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis
EVpredict
1 other identifier
observational
378
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2026
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2026
CompletedFirst Posted
Study publicly available on registry
January 29, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
January 29, 2026
January 1, 2026
3 years
January 22, 2026
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target protein levels in plasma-derived extracellular vesicles (EVs) measured by multiplex ELISA before treatment
Treatment response assessed as Best Overall Response (BOR: complete or partial response per RECIST 1.1) within 6 months.
6 months from treatment initiation
Study Arms (1)
Advanced NSCLC or Melanoma - Anti-PD-(L)1 Therapy
This cohort includes patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or inoperable melanoma who are receiving standard-of-care anti-PD-1 or anti-PD-L1 therapy, either as monotherapy or in combination with other approved therapies. Participants will follow standard clinical management, and study-specific procedures include four blood draws for extracellular vesicle (EV) analysis at baseline and during follow-up, collection of standard immunohistochemistry results (PD-1, PD-L1, CTLA-4, Tim-3, LAG-3, TIGIT), thoraco-abdominopelvic CT imaging, and tumor DNA genotyping performed as part of routine care.
Eligibility Criteria
Patients with non-small cell lung cancer (NSCLC) or melanoma, locally advanced or metastatic, and unresectable. For all patients, first-line standard treatment will be based on standard care with an anti-PD-(L)1 therapy, either as monotherapy or in combination (with other immune checkpoint inhibitors or chemotherapy). Standard treatments are defined by the approved indications (marketing authorizations) in France.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CHU Besançon - Service Dermatologie
Besançon, 25000, France
CHU Besançon - Service Pneumologie Oncologie Thoracique
Besançon, 25000, France
Centre Georges-François Leclerc
Dijon, 21000, France
CHU Dijon - Service Oncologie Médicale
Dijon, 21000, France
Centre Leon Berard - Service Oncologie Médicale
Lyon, 69000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jessica JG GOBBO, Clinical Research Scientist
Centre Georges François Leclerc
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2026
First Posted
January 29, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2030
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share