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

Primary Purpose

Melanoma, Non Small Cell Lung Cancer, Renal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Melanoma focused on measuring imunotherapy, biomarkers, prognostic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

determination of soluble PDL1
ng/mL
determination of soluble B2M
mg/L
Imaging tumor response
RECIST1.1 criteria
Imaging tumor response
RECIST1.1 criteria
Imaging tumor response
RECIST1.1 criteria
Imaging tumor response
RECIST1.1 criteria

Secondary Outcome Measures

progression-free survival
RECIST1.1 criteria
progression-free survival
RECIST1.1 criteria
overall survival
Alive or Dead
overall survival
Alive or Dead
level of tumor PDL1
determination of soluble PDL1
ng/mL
determination of soluble PDL1
ng/mL
determination of soluble PDL1
ng/mL
determination of soluble PDL1
ng/mL
determination of soluble B2M
mg/L
determination of soluble B2M
mg/L
determination of soluble B2M
mg/L
determination of soluble B2M
mg/L
adverse events
CTCAE
adverse events
CTCAE
adverse events
CTCAE
adverse events
CTCAE

Full Information

First Posted
January 14, 2022
Last Updated
June 16, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05426317
Brief Title
Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Non Small Cell Lung Cancer, Renal Cancer
Keywords
imunotherapy, biomarkers, prognostic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
metastatic solid tumor
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Blood sample
Other Intervention Name(s)
Archived tumor sample
Intervention 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).
Primary Outcome Measure Information:
Title
determination of soluble PDL1
Description
ng/mL
Time Frame
the day of the start of immunotherapy
Title
determination of soluble B2M
Description
mg/L
Time Frame
the day of the start of immunotherapy
Title
Imaging tumor response
Description
RECIST1.1 criteria
Time Frame
3 month after inclusion
Title
Imaging tumor response
Description
RECIST1.1 criteria
Time Frame
6 month after inclusion
Title
Imaging tumor response
Description
RECIST1.1 criteria
Time Frame
9 month after inclusion
Title
Imaging tumor response
Description
RECIST1.1 criteria
Time Frame
12 month after inclusion
Secondary Outcome Measure Information:
Title
progression-free survival
Description
RECIST1.1 criteria
Time Frame
6 month after inclusion
Title
progression-free survival
Description
RECIST1.1 criteria
Time Frame
12 month after inclusion
Title
overall survival
Description
Alive or Dead
Time Frame
6 month after inclusion
Title
overall survival
Description
Alive or Dead
Time Frame
12 month after inclusion
Title
level of tumor PDL1
Time Frame
CYCLE 1 DAY 1 (each cycle is 21 days)
Title
determination of soluble PDL1
Description
ng/mL
Time Frame
3 month after inclusion
Title
determination of soluble PDL1
Description
ng/mL
Time Frame
6 month after inclusion
Title
determination of soluble PDL1
Description
ng/mL
Time Frame
9 month after inclusion
Title
determination of soluble PDL1
Description
ng/mL
Time Frame
12 month after inclusion
Title
determination of soluble B2M
Description
mg/L
Time Frame
3 month after inclusion
Title
determination of soluble B2M
Description
mg/L
Time Frame
6 month after inclusion
Title
determination of soluble B2M
Description
mg/L
Time Frame
9 month after inclusion
Title
determination of soluble B2M
Description
mg/L
Time Frame
12 month after inclusion
Title
adverse events
Description
CTCAE
Time Frame
3 month after inclusion
Title
adverse events
Description
CTCAE
Time Frame
6 month after inclusion
Title
adverse events
Description
CTCAE
Time Frame
9 month after inclusion
Title
adverse events
Description
CTCAE
Time Frame
12 month after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurore DOUGE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Aurore DOUGE

12. IPD Sharing Statement

Learn more about this trial

Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression

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