Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression

Melanoma Clinical Trial

— Onco-PDL1s/B2M  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426317
• Other study ID #: RBHP 2021 DOUGE
• Secondary ID: 2021-A02495-36
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: February 2024

Study information

• Verified date: January 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Neoplasms
• Melanoma
• Non Small Cell Lung Cancer
• Renal Cancer

Intervention

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).

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determination of soluble PDL1	ng/mL	the day of the start of immunotherapy
Primary	determination of soluble B2M	mg/L	the day of the start of immunotherapy
Primary	Imaging tumor response	RECIST1.1 criteria	3 month after inclusion
Primary	Imaging tumor response	RECIST1.1 criteria	6 month after inclusion
Primary	Imaging tumor response	RECIST1.1 criteria	9 month after inclusion
Primary	Imaging tumor response	RECIST1.1 criteria	12 month after inclusion
Secondary	progression-free survival	RECIST1.1 criteria	6 month after inclusion
Secondary	progression-free survival	RECIST1.1 criteria	12 month after inclusion
Secondary	overall survival	Alive or Dead	6 month after inclusion
Secondary	overall survival	Alive or Dead	12 month after inclusion
Secondary	level of tumor PDL1		CYCLE 1 DAY 1 (each cycle is 21 days)
Secondary	determination of soluble PDL1	ng/mL	3 month after inclusion
Secondary	determination of soluble PDL1	ng/mL	6 month after inclusion
Secondary	determination of soluble PDL1	ng/mL	9 month after inclusion
Secondary	determination of soluble PDL1	ng/mL	12 month after inclusion
Secondary	determination of soluble B2M	mg/L	3 month after inclusion
Secondary	determination of soluble B2M	mg/L	6 month after inclusion
Secondary	determination of soluble B2M	mg/L	9 month after inclusion
Secondary	determination of soluble B2M	mg/L	12 month after inclusion
Secondary	adverse events	CTCAE	3 month after inclusion
Secondary	adverse events	CTCAE	6 month after inclusion
Secondary	adverse events	CTCAE	9 month after inclusion
Secondary	adverse events	CTCAE	12 month after inclusion