Clinical trial NCT05426317: Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Melanoma
Non Small Cell Lung Cancer
Renal Cancer
Keywords: imunotherapy
biomarkers
prognostic
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: metastatic solid tumor
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: determination of soluble PDL1
timeFrame: the day of the start of immunotherapy
measure: determination of soluble B2M
timeFrame: the day of the start of immunotherapy
measure: Imaging tumor response
timeFrame: 3 month after inclusion
measure: Imaging tumor response
timeFrame: 6 month after inclusion
measure: Imaging tumor response
timeFrame: 9 month after inclusion
measure: Imaging tumor response
timeFrame: 12 month after inclusion
Secondary outcomes:
measure: progression-free survival
timeFrame: 6 month after inclusion
measure: progression-free survival
timeFrame: 12 month after inclusion
measure: overall survival
timeFrame: 6 month after inclusion
measure: overall survival
timeFrame: 12 month after inclusion
measure: level of tumor PDL1
timeFrame: CYCLE 1 DAY 1 (each cycle is 21 days)
measure: determination of soluble PDL1
timeFrame: 3 month after inclusion
measure: determination of soluble PDL1
timeFrame: 6 month after inclusion
measure: determination of soluble PDL1
timeFrame: 9 month after inclusion
measure: determination of soluble PDL1
timeFrame: 12 month after inclusion
measure: determination of soluble B2M
timeFrame: 3 month after inclusion
measure: determination of soluble B2M
timeFrame: 6 month after inclusion
measure: determination of soluble B2M
timeFrame: 9 month after inclusion
measure: determination of soluble B2M
timeFrame: 12 month after inclusion
measure: adverse events
timeFrame: 3 month after inclusion
measure: adverse events
timeFrame: 6 month after inclusion
measure: adverse events
timeFrame: 9 month after inclusion
measure: adverse events
timeFrame: 12 month after inclusion
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Aurore DOUGE
role: PRINCIPAL_INVESTIGATOR
References: