Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression

Not Applicable

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

• Registration Number: NCT05426317
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-14
• Study Start: 2022-02-10
• Study First Submitted QC: 2022-06-16
• Last Update Submitted: 2022-06-16
• Study First Posted: 2022-06-22
• Last Update Posted: 2022-06-22
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	12 month after inclusion	RECIST1.1 criteria

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France