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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Non Small Cell Lung Cancer; Renal Cancer
• Intervention / Treatment: Other: Blood sample

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Aurore DOUGE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor; 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.

Other: Blood 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).; Other Names: Archived tumor sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
determination of soluble PDL1	ng/mL	the day of the start of immunotherapy
determination of soluble B2M	mg/L	the day of the start of immunotherapy
Imaging tumor response	RECIST1.1 criteria	3 month after inclusion
Imaging tumor response	RECIST1.1 criteria	6 month after inclusion
Imaging tumor response	RECIST1.1 criteria	9 month after inclusion
Imaging tumor response	RECIST1.1 criteria	12 month after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	RECIST1.1 criteria	6 month after inclusion
progression-free survival	RECIST1.1 criteria	12 month after inclusion
overall survival	Alive or Dead	6 month after inclusion
overall survival	Alive or Dead	12 month after inclusion
level of tumor PDL1		CYCLE 1 DAY 1 (each cycle is 21 days)
determination of soluble PDL1	ng/mL	3 month after inclusion
determination of soluble PDL1	ng/mL	6 month after inclusion
determination of soluble PDL1	ng/mL	9 month after inclusion
determination of soluble PDL1	ng/mL	12 month after inclusion
determination of soluble B2M	mg/L	3 month after inclusion
determination of soluble B2M	mg/L	6 month after inclusion
determination of soluble B2M	mg/L	9 month after inclusion
determination of soluble B2M	mg/L	12 month after inclusion
adverse events	CTCAE	3 month after inclusion
adverse events	CTCAE	6 month after inclusion
adverse events	CTCAE	9 month after inclusion
adverse events	CTCAE	12 month after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Aurore DOUGE, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: biomarkers; prognostic; imunotherapy
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms
• Other Study ID Numbers: RBHP 2021 DOUGE; 2021-A02495-36 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No