Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression (Onco-PDL1s/B2M)

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Melanoma; Renal Cancer; Non Small Cell Lung Cancer

Treatments: Other: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT05426317

2021-A02495-36 (Other Identifier)

RBHP 2021 DOUGE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor

Other group

Description:

* 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.

Treatment:

Other: Blood sample