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This is an open bi-centric prospective non-randomized study in patients with metastatic melanoma treated with a first line treatment of Nivolumab +/- Ipilimumab. The aim of the study is to characterize the immune cells modulations under anti-PD-1 +/- anti-CTLA4 and identify the differences between responder and non-responder patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab | Other | Previous untreated patient with metastatic melanoma eligible for a Nivolumab treatment. 30 patients will be included in the arm. |
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| Nivolumab + Ipilimumab | Other | Previous untreated patient with metastatic melanoma eligible for a Nivolumab + Ipilimumab treatment. 30 patients will be included in the arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and biopsy sampling | Biological | Blood samples (52mL) will be taken at week 1, week 3, week 7, week 13, week 53 or at the progression. Skin biopsies will be taken at week 1, week 7, week 53 or at the progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Change description of biological characteristics of immune cells of the blood by immunomonitoring. | Biological characteristics description of monocytes, dendritic cell and T cells subpopulations including different circulating suppressive subpopulations by immunomonitoring | Week 1 (baseline, before the 1st injection), week 3 (before the 2d injection treatment), week 7 (before the 4th) , week 13 (before the 5th), week 53 (before the 26th or during radiological evaluation) or at the progression |
| Change in the immune response by skin biopsy. | Week 1 (Baseline), week 7, week 53 or at the progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression free survival (PFS) will be calculated as the period of time from the immunotherapy first administration to the first RECIST 1.1 disease progression | Week1 , every radiological assessments defined by standard care (not by specific time frame) |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL) | Pierre-Bénite | 69310 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38939518 | Result | Dalle S, Verronese E, N'Kodia A, Bardin C, Rodriguez C, Andrieu T, Eberhardt A, Chemin G, Hasan U, Le-Bouar M, Caramel J, Amini-Adle M, Bendriss-Vermare N, Dubois B, Caux C, Menetrier-Caux C. Modulation of blood T cell polyfunctionality and HVEM/BTLA expression are critical determinants of clinical outcome in anti-PD1-treated metastatic melanoma patients. Oncoimmunology. 2024 Jun 26;13(1):2372118. doi: 10.1080/2162402X.2024.2372118. eCollection 2024. |
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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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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Overall survival (OS) will be calculated as the period of time from the immunotherapy first administration to the patient's death. |
| week 1, date of patient death |
| Auto-immune adverse event frequency | Immune adverse event description by clinical examination and correlation with biological characteristics of immune cells | baseline, week 53 or at the progression |
| Subtype of melanoma correlated with biological characteristics of immune cells | Subtype of melanoma defined by histological analysis correlated with biological characteristics of immune cells | baseline |
| Immunity gene polymorphism correlated with biological characteristics of immune cells | Immunity gene polymorphism defined by RNA sequencing correlated with biological characteristics of immune cells immune cells | Week 1, week 3, week 7, week 13, week 53 or at the progression. |
| 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 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |