Melanoma, Non Small Cell Lung Cancer, Renal Cancer
Conditions
Keywords
imunotherapy, biomarkers, prognostic
Brief summary
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
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.
Interventions
OTHERBlood sample
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).
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
metastatic solid tumor
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| determination of soluble PDL1 | the day of the start of immunotherapy | ng/mL |
| determination of soluble B2M | the day of the start of immunotherapy | mg/L |
| Imaging tumor response | 3 month after inclusion | RECIST1.1 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| determination of soluble PDL1 | 3 month after inclusion | ng/mL |
| progression-free survival | 6 month after inclusion | RECIST1.1 criteria |
| adverse events | 3 month after inclusion | CTCAE |
| determination of soluble B2M | 3 month after inclusion | mg/L |
| overall survival | 6 month after inclusion | Alive or Dead |
| level of tumor PDL1 | CYCLE 1 DAY 1 (each cycle is 21 days) | — |
Countries
France
Contacts
Primary ContactLise LACLAUTRE
Outcome results
None listed