Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression

Study Overview
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Brief Summary
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Exploratory interventional study of prognostic serum biomarkers of cancer progression. Study of the relationship between the blood levels of soluble PDL1 and β2-microglobulin, and the clinical course of a metastatic solid tumor treated with a first-line therapeutic of checkpoint immune inhibitor.

Detailed Description
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Primary objective To study the relationship between the blood levels of soluble PDL1 and β2-microglobulin measured at the diagnostic stage, and the clinical course of a metastatic solid tumor (non-small cell lung cancer, kidney cancer, or melanoma) treated with a 1st line therapeutic immune checkpoint inhibitor. The secondary objectives are: To study the relationship between the blood levels of soluble PDL1 and β2-microglobulin measured during treatment, and the clinical course of a metastatic solid tumor treated with a first-line therapeutic immune checkpoint inhibitor. To study the correlation between the soluble PDL1 level and the tumor PDL1 level. To study the correlation between the blood levels of soluble PDL1 and β2-microglobulin. To study the relationship between the blood levels of soluble PDL1 and β2-microglobulin measured during the treatment, and the tolerance of treatment with immune checkpoint inhibitor in 1st line therapy.

Official Title
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Study of the Relationship Between the Blood Levels of Soluble PDL1 and β2-microglobulin, and the Clinical Course of a Metastatic Solid Tumor Treated With a First-line Therapeutic of Checkpoint Immune Inhibitor

Conditions
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Melanoma, Non Small Cell Lung Cancer, Renal Cancer

Intervention / Treatment
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* Other: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient, male or female, with metastatic cancer of the non-small cell, renal or malignant melanoma type, eligible for treatment with a first-line immune checkpoint inhibitor (immunotherapy alone or in combination with another immunotherapy, chemotherapy or targeted therapy). Affiliation to a Social Security organization Able to give informed consent to participate in research. Exclusion Criteria: Pregnant women Patient under guardianship, curatorship or legal protection Patient unable to understand the protocol (language barrier, cognitive difficulties) Patient with another active cancer Patient with creatinine clearance <60 mL / min Patient participating in a therapeutic clinical trial Refusal of participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: metastatic solid tumor
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor<br>The determinations of soluble PDL1 and serum B2M will be taken by blood sample at diagnosis and then every 3 months for 1 year, during a consultation or treatment in an outpatient hospital. The measurement of the tumor PDL1 level at diagnosis will be carried out by immunohistochemistry in the anatomopathology department of Clermont Ferrand University Hospital on the tumor sample that allowed the diagnosis, which does not add an additional sample for the patient. Clinical and imaging examinations will be those conventionally carried out in the context of patient monitoring, the data will only be recorded in the patients' medical files. | Other: Blood sample<br>* This study only involves the patient taking 5 additional blood tests (peripheral venipuncture) compared to his usual care, which will be taken when he comes to the hospital. Each sample only requires a blood volume of 5mL (one tube), or a total blood volume of 25mL for the study (one blood test every 3 months for one year).<br>* Other names: Archived tumor sample;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determination of soluble PDL1 | ng/mL | the day of the start of immunotherapy | 
| determination of soluble B2M | mg/L | the day of the start of immunotherapy | 
| Imaging tumor response | RECIST1.1 criteria | 3 month after inclusion | 
| Imaging tumor response | RECIST1.1 criteria | 6 month after inclusion | 
| Imaging tumor response | RECIST1.1 criteria | 9 month after inclusion | 
| Imaging tumor response | RECIST1.1 criteria | 12 month after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | RECIST1.1 criteria | 6 month after inclusion | 
| progression-free survival | RECIST1.1 criteria | 12 month after inclusion | 
| overall survival | Alive or Dead | 6 month after inclusion | 
| overall survival | Alive or Dead | 12 month after inclusion | 
| level of tumor PDL1 |  | CYCLE 1 DAY 1 (each cycle is 21 days) | 
| determination of soluble PDL1 | ng/mL | 3 month after inclusion | 
| determination of soluble PDL1 | ng/mL | 6 month after inclusion | 
| determination of soluble PDL1 | ng/mL | 9 month after inclusion | 
| determination of soluble PDL1 | ng/mL | 12 month after inclusion | 
| determination of soluble B2M | mg/L | 3 month after inclusion | 
| determination of soluble B2M | mg/L | 6 month after inclusion | 
| determination of soluble B2M | mg/L | 9 month after inclusion | 
| determination of soluble B2M | mg/L | 12 month after inclusion | 
| adverse events | CTCAE | 3 month after inclusion | 
| adverse events | CTCAE | 6 month after inclusion | 
| adverse events | CTCAE | 9 month after inclusion | 
| adverse events | CTCAE | 12 month after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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imunotherapy, biomarkers, prognostic