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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02695-52 | Registry Identifier | IDRCB |
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The primary objective of the study aims to compare the immune profiles (circulating cytokines and lymphocytes) before and after (6 to 8 weeks) the first infusion of immune checkpoint inhibitors in patients with melanoma treated in the adjuvant setting(cohort A) or in metastatic setting(cohort B); and to study the association of these immune profiles with relapse- or progression-free survival.
This study will analyse the association of biomarkers with relapse- or progression-free survival of stage III or IV melanoma patients, divided in 3 sub-cohorts:
For patients of cohort A and B1, immune profiles characteristics will be evaluated before initiation of treatment (=baseline), and at each radiological evaluation of the tumour response, up to maximum 12 months as duration.
The maximal duration of treatment will be 12 months for patients treated in the adjuvant setting. For metastatic patients, the duration of treatment will be decided by physician according to different factors (responses, progression, toxicities, ...).
For patients in cohort B2, the characteristics of the immune profiles will be evaluated before radiotherapy initiation,, within 6 weeks after the end of radiotherapy, then at the 2 following radiological evaluations of the tumour response
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental |
| |
| comparator group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venous puncture | Procedure | Venous punctures will be performed: for patients of cohort A and B1:
for patients of cohort B2:
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of relapse/progression-free survival | Will be noted: all progression and event of death. Survival rate will be calculated between the event's day and the beginning of anticancer treatment. | at 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| immunity profiles | ELISA Multiplex method will be used to analyse inflammatory human cytokines in plasma. This method will performe an assay 45-plex fixed panel : Analytes Included in the Assay
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa FUNCK-BRENTANO, MD | Contact | +33 (0)1 71 16 77 21 | elisa.funck-brentano@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Elisa FUNCK-BRENTANO, MD | Dermato-oncology department, Ambroise Paré hospital, APHP | Principal Investigator |
| Jean-François EMILE, MD, PhD | Pathology department, Ambroise Paré hospital, APHP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermato-oncology department, Ambroise Paré hospital, APHP | Recruiting | Boulogne-Billancourt | 92100 | France |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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|
| tumoral biopsy | Procedure | Cutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care. |
|
| quarterly up to 12 months |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |