Predicting Response to Anti-PD-1/PD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Georges Francois Leclerc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
378 Participants
are grouped into 1 trial groupGroup A: Advanced NSCLC or Melanoma - Anti-PD-(L)1 Therapy
Trial outcomes
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.
Time frame
6 months from treatment initiationSponsors and contacts
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Source ClinicalTrials.gov
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