Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy (ImmuCCo-1905)
Primary Purpose
Solid Tumor, Adult, Metastasis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ImmuCCo Cohort
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumor, Adult focused on measuring Prospective cohort, Clinic-biologic database, Solid tumor, Immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Beginning a first immunotherapy by immune checkpoint inhibitor - anti-PD1 (Programmed cell Death protein-1), anti-PDL1 (Programmed cell Death protein-1 ligand), anti-CTLA4 (Cytotoxic T-Lymphocyte associated protein 4), as monotherapy or in combination, in the Centre Oscar Lambret (COL)
- In adjuvant or metastatic situation
- Suffering from solid tumor histologically documented
- Signed written informed consent
- Patient covered by the French " "Social Security" regime If the patient is already enrolled in clinical trial involving immunotherapy, the agreement of the sponsor of this new trial will be sought before his/her inclusion.
Exclusion Criteria:
- Pregnant or breastfeeding women
- Patient already treated by immunotherapy by immune checkpoint inhibitor
- Person under guardianship
- Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
Sites / Locations
- Centre Oscar LambretRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ImmuCCo Cohort
Arm Description
Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy.
Outcomes
Primary Outcome Measures
Number of patients treated by immunotherapy and registered in the database.
Number of patients treated by immunotherapy and registered in the database
Secondary Outcome Measures
Overall Survival
Time between date of start of immunotherapy to date of death whatever the cause. Patients alive at last follow-up will be censored.
Progression-Free Survival
Time between start of immunotherapy to date of disease progression or death whatever the cause. Alive, non-progressive patients at last follow-up will be censored.
Tumor response
Tumor response will be based on the first tumor assessment performed during the immunotherapy. Objective response according to iRECIST (Response Evaluation Criteria in Solid Tumours for immunotherapy) criteria will be defined at the first tumor assessment and during the course of the treatment, meaning until disease progression of start of another systemic treatment.
Responses will be: Complete response (iCR), partial response (iPR), stability (iSD), progression, or pseudo-progression. Confirmed progressive disease (iCPD) will be distinguished from pseudo-progression (iUPD) according to control images. Hyper-progression will be defined as a progression according to iRECIST criteria and a doubling of tumor growth rate.
A prolonged tumor response will be defined as a progression free survival duration at least 3 time superior to median duration of progression free survival of patients of the study presenting the same disease.
Co-medications
All comedications given during the course of the study will be compiled
Toxicity of immunotherapy
All Adverse events occuring from the start of the immunotherapy to the follow-up performed on year after the end of the immunotherapy will be notified, whatever the grade and the relationship with immunotherapy, apart from those undoubtfully related to the disease or the progression of the disease.The AE will also be notified in case of start of a second line of treatment, apart from thos undoubtfully related to this second line of treatment. The main analysis will be done on AE potentially related to immunotherapy. The relationship will be evaluated by a medical expert of immunotherapy. AE will be graded according to CTCAE v5.0 classification. Patients who received less than 4 doses will be considered non-evaluable for this outcome apart from those who discontinued treatment because they had a toxicity. Each AE with a grade > 2 and/or leading to treatment discontinuation will be considered as severe.
Full Information
NCT ID
NCT05223608
First Posted
January 24, 2022
Last Updated
August 30, 2023
Sponsor
Centre Oscar Lambret
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT05223608
Brief Title
Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy
Acronym
ImmuCCo-1905
Official Title
Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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
ImmuCCo-1905 is a monocentric interventional study on patients treated by immunotherapy, which consist in establishment of a prospective clinic-biologic database over 5 years, associated with a biobank. This database will allow carrying out works aiming at assessing immunotherapy in real life situation.
Detailed Description
The aim of this study is to establish a prospective clinic-biologic database of patients treated by immunotherapy. This database will allowed to carry out works (such as translational research) aiming at assessing immunotherapy in real life situation.
Other objectives of the study include:
Describe overall survival, progression-free survival, response to immunotherapy (in particular hyper-progression, pseudo-progression) considering the first tumor assessment and the best response, prolonged response
Identifying prognostic factors of overall survival, progression-free survival, hyper-progression, best response under immunotherapy
Describe AEs (Adverse Events) potentially associated with immunotherapy, their kinetics of appearance, from the start of treatment and after the end of treatment in order to assess the risk of delayed appearance
To identify factors associated with increased risk of severe adverse event (grade > 2 or leading to end of treatment) potentially related to immunotherapy, from the beginning of immunotherapy to 1 year after this start of the treatment, in patients who received at least 4 doses or who stopped the treatment earlier (before 4 doses) due to toxicity.
Identifying delayed adverse events potentially related to immunotherapy, occurring between 90 days and 1 year after the treatment discontinuation, in patients who received at least 4 doses or who stopped the treatment earlier (before 4 doses) due to toxicity.
To identify and describe rare toxicities
To evaluate the association between co-medications and disease evolution
To evaluate the association between co-medications and toxicities occurrence
Translational research objectives:
To identify biomarkers that might be associated with tumor response and/or toxicity of immunotherapy from:
Establishment of serum and plasma bank which will be used for diverse works;
A systematic analysis of the lymphocyte profile
To study the impact of tabagism on efficacy and toxicity of immunotherapy from systematic collection of urinary cotinine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Adult, Metastasis
Keywords
Prospective cohort, Clinic-biologic database, Solid tumor, Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Observational study model with additional blood samples and urine collection
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ImmuCCo Cohort
Arm Type
Other
Arm Description
Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity.
Urine collection at initiation of immunotherapy.
Intervention Type
Other
Intervention Name(s)
ImmuCCo Cohort
Intervention Description
Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy.
Primary Outcome Measure Information:
Title
Number of patients treated by immunotherapy and registered in the database.
Description
Number of patients treated by immunotherapy and registered in the database
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Time between date of start of immunotherapy to date of death whatever the cause. Patients alive at last follow-up will be censored.
Time Frame
6 years
Title
Progression-Free Survival
Description
Time between start of immunotherapy to date of disease progression or death whatever the cause. Alive, non-progressive patients at last follow-up will be censored.
Time Frame
6 years
Title
Tumor response
Description
Tumor response will be based on the first tumor assessment performed during the immunotherapy. Objective response according to iRECIST (Response Evaluation Criteria in Solid Tumours for immunotherapy) criteria will be defined at the first tumor assessment and during the course of the treatment, meaning until disease progression of start of another systemic treatment.
Responses will be: Complete response (iCR), partial response (iPR), stability (iSD), progression, or pseudo-progression. Confirmed progressive disease (iCPD) will be distinguished from pseudo-progression (iUPD) according to control images. Hyper-progression will be defined as a progression according to iRECIST criteria and a doubling of tumor growth rate.
A prolonged tumor response will be defined as a progression free survival duration at least 3 time superior to median duration of progression free survival of patients of the study presenting the same disease.
Time Frame
6 years
Title
Co-medications
Description
All comedications given during the course of the study will be compiled
Time Frame
6 years
Title
Toxicity of immunotherapy
Description
All Adverse events occuring from the start of the immunotherapy to the follow-up performed on year after the end of the immunotherapy will be notified, whatever the grade and the relationship with immunotherapy, apart from those undoubtfully related to the disease or the progression of the disease.The AE will also be notified in case of start of a second line of treatment, apart from thos undoubtfully related to this second line of treatment. The main analysis will be done on AE potentially related to immunotherapy. The relationship will be evaluated by a medical expert of immunotherapy. AE will be graded according to CTCAE v5.0 classification. Patients who received less than 4 doses will be considered non-evaluable for this outcome apart from those who discontinued treatment because they had a toxicity. Each AE with a grade > 2 and/or leading to treatment discontinuation will be considered as severe.
Time Frame
6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Beginning a first immunotherapy by immune checkpoint inhibitor - anti-PD1 (Programmed cell Death protein-1), anti-PDL1 (Programmed cell Death protein-1 ligand), anti-CTLA4 (Cytotoxic T-Lymphocyte associated protein 4), as monotherapy or in combination, in the Centre Oscar Lambret (COL)
In adjuvant or metastatic situation
Suffering from solid tumor histologically documented
Signed written informed consent
Patient covered by the French " "Social Security" regime If the patient is already enrolled in clinical trial involving immunotherapy, the agreement of the sponsor of this new trial will be sought before his/her inclusion.
Exclusion Criteria:
Pregnant or breastfeeding women
Patient already treated by immunotherapy by immune checkpoint inhibitor
Person under guardianship
Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien THERY
Phone
+33320295918
Email
promotion@o-lambret.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marjane BELMIMOUN
Phone
+33320295918
Email
promotion@o-lambret.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra FORESTIER, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra FORESTIER
Phone
03 20 29 59 59
Email
a-forestier@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Alexandra FORESTIER
12. IPD Sharing Statement
Learn more about this trial
Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy
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