Clinical trial · Observational
Predicting Response to Anti-PD-1/PD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Advanced NSCLC or Melanoma - Anti-PD-(L)1 Therapy
- description
- 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.
Primary outcomes (1)
- measure
- Target protein levels in plasma-derived extracellular vesicles (EVs) measured by multiplex ELISA before treatment
- timeFrame
- 6 months from treatment initiation
- description
- Treatment response assessed as Best Overall Response (BOR: complete or partial response per RECIST 1.1) within 6 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available