Ignite Creation Date:
2024-05-06 @ 2:13 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04253080
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2020-01-31
Brief Title:
Expression of IL4 Induced Gene 1 in Patients With Cutaneous Melanoma Value in Prognosis andor in Predictive Response to Immune Checkpoint Inhibitors
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Impact of the IL4I1 Enzyme Expression in Patients With Cutaneous Melanoma Prognostic Value andor Role in Resistance to Current Immunotherapy and Targeted Therapy
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENZYMELA
Brief Summary:
To characterize and quantify immune cells expressing the Interleukine 4 induced gene 1 IL4I1 immunosuppressive enzyme in the blood and in tissue of melanoma patients primary tumor sentinel lymph nodes and cutaneous metastases
Then to compare the results obtained in different clinical settings
in cases of progression of the disease slower or faster compared to the prognosis established by clinical and pathological data
before and after treatments with immunotherapy anti Programmed Death ligand 1 anti-PD1 or anti-PD1 and anti Cytotoxic T Lymphocyte associated protein 4 anti-CTLA-4 and or targeted therapies BRAF inhibitors and or methyl ethyl ketone MEK
Then to compare the results obtained in different clinical settings
in cases of progression of the disease slower or faster compared to the prognosis established by clinical and pathological data
before and after treatments with immunotherapy anti Programmed Death ligand 1 anti-PD1 or anti-PD1 and anti Cytotoxic T Lymphocyte associated protein 4 anti-CTLA-4 and or targeted therapies BRAF inhibitors and or methyl ethyl ketone MEK
Detailed Description:
The incidence of cutaneous melanoma is increasing but the current prognostic parameters mainly based on histological data are insufficient to identify patients with high risk of recidive In addition current immunotherapies using PD-1 andor CTLA-4 antibodies have long-lasting tumor control in a substantial fraction of patients but identify new markers of treatment resistance need further investigations Clinical data highlight enzymes involved in amino acid catabolism as new potential prognostic markers in human melanoma Among those the IL4I1 phenylalanine oxidase may be a new relevant marker and may represent an easily targetable molecule for cancer immunotherapy
The current retrospective study is designed to evaluate whether a high proportion of IL4I1 positive cells within the primary tumor andor sentinel lymph nodes allows to predict the risk of cancer recurrence from the clinical diagnosis Immunofluorescence and immunohistochemistry will be performed
The longitudinal study of IL4I1 positive cells in the blood and cutaneous metastasis od patients will start before and after three months and 1 year or before in case of treatment resistance the treatment with targeted therapy andor immunotherapy as a first line Treatment will be administered on an outpatient basis No investigational or commercial cancer directed agents or therapies other than those described below may be administered
It is designed to evaluate whether patients that resist to treatments exhibit a high proportion of IL4I1 positive cells and how is regulated the enzyme in the course of the treatment
The current retrospective study is designed to evaluate whether a high proportion of IL4I1 positive cells within the primary tumor andor sentinel lymph nodes allows to predict the risk of cancer recurrence from the clinical diagnosis Immunofluorescence and immunohistochemistry will be performed
The longitudinal study of IL4I1 positive cells in the blood and cutaneous metastasis od patients will start before and after three months and 1 year or before in case of treatment resistance the treatment with targeted therapy andor immunotherapy as a first line Treatment will be administered on an outpatient basis No investigational or commercial cancer directed agents or therapies other than those described below may be administered
It is designed to evaluate whether patients that resist to treatments exhibit a high proportion of IL4I1 positive cells and how is regulated the enzyme in the course of the treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A01985-52 | REGISTRY | ID-RCB | None |