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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Recruiting

CT.gov ID

NCT05426317

Collaborator

(none)

100

Enrollment

Location

Arm

23.7

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Non Small Cell Lung Cancer Renal Cancer	Other: Blood sample	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

metastatic solid tumormetastatic solid tumor

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Feb 10, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 [3 month after inclusion]
RECIST1.1 criteria
Imaging tumor response [6 month after inclusion]
RECIST1.1 criteria
Imaging tumor response [9 month after inclusion]
RECIST1.1 criteria
Imaging tumor response [12 month after inclusion]
RECIST1.1 criteria

Secondary Outcome Measures

progression-free survival [6 month after inclusion]
RECIST1.1 criteria
progression-free survival [12 month after inclusion]
RECIST1.1 criteria
overall survival [6 month after inclusion]
Alive or Dead
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 [3 month after inclusion]
ng/mL
determination of soluble PDL1 [6 month after inclusion]
ng/mL
determination of soluble PDL1 [9 month after inclusion]
ng/mL
determination of soluble PDL1 [12 month after inclusion]
ng/mL
determination of soluble B2M [3 month after inclusion]
mg/L
determination of soluble B2M [6 month after inclusion]
mg/L
determination of soluble B2M [9 month after inclusion]
mg/L
determination of soluble B2M [12 month after inclusion]
mg/L
adverse events [3 month after inclusion]
CTCAE
adverse events [6 month after inclusion]
CTCAE
adverse events [9 month after inclusion]
CTCAE
adverse events [12 month after inclusion]
CTCAE

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Clermont-Ferrand	Clermont-Ferrand		France	63000

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator: Aurore DOUGE, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT05426317

Other Study ID Numbers:

RBHP 2021 DOUGE
2021-A02495-36

First Posted:

Jun 22, 2022

Last Update Posted:

Jun 22, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Clermont-Ferrand

imunotherapy

biomarkers

prognostic

Additional relevant MeSH terms:

Kidney Neoplasms

Study Results

No Results Posted as of Jun 22, 2022