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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
100
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).
CHU de Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGdetermination of soluble PDL1
ng/mL
Time frame: the day of the start of immunotherapy
determination of soluble B2M
mg/L
Time frame: the day of the start of immunotherapy
Imaging tumor response
RECIST1.1 criteria
Time frame: 3 month after inclusion
Imaging tumor response
RECIST1.1 criteria
Time frame: 6 month after inclusion
Imaging tumor response
RECIST1.1 criteria
Time frame: 9 month after inclusion
Imaging tumor response
RECIST1.1 criteria
Time frame: 12 month after inclusion
progression-free survival
RECIST1.1 criteria
Time frame: 6 month after inclusion
progression-free survival
RECIST1.1 criteria
Time frame: 12 month after inclusion
overall survival
Alive or Dead
Time frame: 6 month after inclusion
overall survival
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Alive or Dead
Time frame: 12 month after inclusion
level of tumor PDL1
Time frame: CYCLE 1 DAY 1 (each cycle is 21 days)
determination of soluble PDL1
ng/mL
Time frame: 3 month after inclusion
determination of soluble PDL1
ng/mL
Time frame: 6 month after inclusion
determination of soluble PDL1
ng/mL
Time frame: 9 month after inclusion
determination of soluble PDL1
ng/mL
Time frame: 12 month after inclusion
determination of soluble B2M
mg/L
Time frame: 3 month after inclusion
determination of soluble B2M
mg/L
Time frame: 6 month after inclusion
determination of soluble B2M
mg/L
Time frame: 9 month after inclusion
determination of soluble B2M
mg/L
Time frame: 12 month after inclusion
adverse events
CTCAE
Time frame: 3 month after inclusion
adverse events
CTCAE
Time frame: 6 month after inclusion
adverse events
CTCAE
Time frame: 9 month after inclusion
adverse events
CTCAE
Time frame: 12 month after inclusion