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

Sponsors

Lead Sponsor: University Hospital, Clermont-Ferrand

Source University Hospital, Clermont-Ferrand
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.

Overall Status Recruiting
Start Date 2022-02-10
Completion Date 2024-02-01
Primary Completion Date 2024-02-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
determination of soluble PDL1 the day of the start of immunotherapy
determination of soluble B2M the day of the start of immunotherapy
Imaging tumor response 3 month after inclusion
Imaging tumor response 6 month after inclusion
Imaging tumor response 9 month after inclusion
Imaging tumor response 12 month after inclusion
Secondary Outcome
Measure Time Frame
progression-free survival 6 month after inclusion
progression-free survival 12 month after inclusion
overall survival 6 month after inclusion
overall survival 12 month after inclusion
level of tumor PDL1 CYCLE 1 DAY 1 (each cycle is 21 days)
determination of soluble PDL1 3 month after inclusion
determination of soluble PDL1 6 month after inclusion
determination of soluble PDL1 9 month after inclusion
determination of soluble PDL1 12 month after inclusion
determination of soluble B2M 3 month after inclusion
determination of soluble B2M 6 month after inclusion
determination of soluble B2M 9 month after inclusion
determination of soluble B2M 12 month after inclusion
adverse events 3 month after inclusion
adverse events 6 month after inclusion
adverse events 9 month after inclusion
adverse events 12 month after inclusion
Enrollment 100
Condition
Intervention

Intervention Type: Other

Intervention Name: Blood sample

Description: 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).

Arm Group Label: Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor

Other Name: Archived tumor sample

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Aurore DOUGE Principal Investigator University Hospital, Clermont-Ferrand
Overall Contact

Last Name: Lise LACLAUTRE

Phone: +33473754963

Email: [email protected]

Location
Facility: Status: Contact: Investigator: CHU de Clermont-Ferrand Lise Laclautre +33473754963 [email protected] Aurore DOUGE Principal Investigator
Location Countries

France

Verification Date

2022-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

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

Type: Other

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.

Acronym Onco-PDL1s/B2M
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: metastatic solid tumor

Primary Purpose: Other

Masking: None (Open Label)

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