MelanomaOnco-PDL1s/B2MNCT05426317
Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression
A study testing Blood sample in people with Melanoma and Non Small Cell Lung Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Non Small Cell Lung Cancer, Renal Cancer
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2022to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Aurore DOUGE
About this study
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
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.
Read the 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.
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Renal Cancer
- Being tested
- Blood sample
- Keywords
- imunotherapy, biomarkers, prognostic
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Also called Archived tumor 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).
| Study group | Role | What they receive |
|---|---|---|
| Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor | Other | * 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. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of soluble PDL1
ng/mL
Measured: the day of the start of immunotherapy
determination of soluble B2M
mg/L
Measured: the day of the start of immunotherapy
Imaging tumor response
RECIST1.1 criteria
Measured: 3 month after inclusion
Imaging tumor response
RECIST1.1 criteria
Measured: 6 month after inclusion
Imaging tumor response
RECIST1.1 criteria
Measured: 9 month after inclusion
Imaging tumor response
RECIST1.1 criteria
Measured: 12 month after inclusion
Secondary outcomes (17)
progression-free survival
RECIST1.1 criteria
Measured: 6 month after inclusion
progression-free survival
RECIST1.1 criteria
Measured: 12 month after inclusion
overall survival
Alive or Dead
Measured: 6 month after inclusion
overall survival
Alive or Dead
Measured: 12 month after inclusion
level of tumor PDL1
Measured: CYCLE 1 DAY 1 (each cycle is 21 days)
determination of soluble PDL1
ng/mL
Measured: 3 month after inclusion
determination of soluble PDL1
ng/mL
Measured: 6 month after inclusion
determination of soluble PDL1
ng/mL
Measured: 9 month after inclusion
determination of soluble PDL1
ng/mL
Measured: 12 month after inclusion
determination of soluble B2M
mg/L
Measured: 3 month after inclusion
determination of soluble B2M
mg/L
Measured: 6 month after inclusion
determination of soluble B2M
mg/L
Measured: 9 month after inclusion
determination of soluble B2M
mg/L
Measured: 12 month after inclusion
adverse events
CTCAE
Measured: 3 month after inclusion
adverse events
CTCAE
Measured: 6 month after inclusion
adverse events
CTCAE
Measured: 9 month after inclusion
adverse events
CTCAE
Measured: 12 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start10 Feb 2022
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- metastatic solid tumor
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurore DOUGE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426317
- Sponsor's protocol ID
- RBHP 2021 DOUGE
- Other IDs
- 2021-A02495-36
- Acronym
- Onco-PDL1s/B2M
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05426317
- Acronym / sponsor ID
- Onco-PDL1s/B2M / RBHP 2021 DOUGE
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Renal Cancer
- Keywords
- imunotherapy, biomarkers, prognostic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- metastatic solid tumor
| Arm | Type | Receives |
|---|---|---|
| Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor | Other | Other: Blood sample* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleAlso: Archived tumor sampleThis 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 | Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor |
Primary outcome
determination of soluble PDL1
Time frame: the day of the start of immunotherapy
ng/mL
determination of soluble B2M
Time frame: the day of the start of immunotherapy
mg/L
Imaging tumor response
Time frame: 3 month after inclusion
RECIST1.1 criteria
Imaging tumor response
Time frame: 6 month after inclusion
RECIST1.1 criteria
Imaging tumor response
Time frame: 9 month after inclusion
RECIST1.1 criteria
Imaging tumor response
Time frame: 12 month after inclusion
RECIST1.1 criteria
17 secondary outcomes
progression-free survival
Time frame: 6 month after inclusion
progression-free survival
Time frame: 12 month after inclusion
overall survival
Time frame: 6 month after inclusion
overall survival
Time frame: 12 month after inclusion
level of tumor PDL1
Time frame: CYCLE 1 DAY 1 (each cycle is 21 days)
determination of soluble PDL1
Time frame: 3 month after inclusion
determination of soluble PDL1
Time frame: 6 month after inclusion
determination of soluble PDL1
Time frame: 9 month after inclusion
determination of soluble PDL1
Time frame: 12 month after inclusion
determination of soluble B2M
Time frame: 3 month after inclusion
determination of soluble B2M
Time frame: 6 month after inclusion
determination of soluble B2M
Time frame: 9 month after inclusion
determination of soluble B2M
Time frame: 12 month after inclusion
adverse events
Time frame: 3 month after inclusion
adverse events
Time frame: 6 month after inclusion
adverse events
Time frame: 9 month after inclusion
adverse events
Time frame: 12 month after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurore DOUGE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Melanoma and Non Small Cell Lung Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination of soluble PDL1 (time frame: the day of the start of immunotherapy). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.