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This is an open mono-centric prospective non-randomized study in patients with metastatic melanoma treated with Anti-PD1 monoclonal antibodies (Nivolumab). The aim of the study is to identify the immune cells modulations differences between patients who present a complete, partial or stable response and patients who have non-response to the therapy in order to establish an improving response rate strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab, patients with BRAF mutation | Experimental | Nivolumab (dose equal to 3mg/kg), 10 mg/ml solution for infusion. injection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks. Blood sampling at different time |
|
| Nivolumab, patients with BRAF wild type | Experimental | Nivolumab (dose equal to 3mg/kg), 10 mg/ml solution for infusion. injection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks. Blood sampling at different time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling | Biological | Blood samples (44mL) will be taken before starting treatment with Nivolumab and at week 2, week 12, week 54 or at relapse (before week 54) |
|
| Measure | Description | Time Frame |
|---|---|---|
| change the absolute number of dendritic cells before treatment and on treatment | absolute number / mm 3 of dendritic cells | before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks) |
| change the percentage of cells producing cytokines in dendritic cells before treatment and on treatment | % of cells producing cytokines in dendritic cells | before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks) |
| change the absolute number of subpopulations of T lymphocytes before treatment and on treatment | absolute number / mm 3 of different subpopulations of T lymphocyte | before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks) |
| change the absolute number of monocytes before treatment and on treatment | absolute number / mm 3 of monocytes | before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks) |
| change the percentage of cells producing cytokines in subpopulations of T lymphocytes before treatment and on treatment | % of cells producing cytokines in subpopulations of T lymphocytes | before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks) |
| change the percentage of cells producing cytokines in monocytes before treatment and on treatment | % of cells producing cytokines in monocytes | before treatment (week 0), at week 2, at week 12, at week 54 or at relapse (before 54 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| correlation between biological parameters and progression-free survival | absolute number / mm 3 of different population of cells and % of cells producing cytokines in the different population of cells will be correlated with the progression free survival | progression between the date of first injection of immunotherapy and week 54 based on RECIST and ir-RECIST criterion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Lyon Sud | 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 |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Nivolumab | Drug | injection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks. |
|
| correlation between biological parameters on overall survival | absolute number / mm 3 of different population of cells and % of cells producing cytokines in the different population of cells will be correlated with the overall survival | death between the date of first injection of immunotherapy and week 54 |
| Identify predictive factors of overall response rate at week 12 based on RECIST and ir-RECIST criteria | predictive factors like histological and cytological initial tumor type, initial immunological status will be evaluated at inclusion and correlated with the response | response evaluation at week 12 |
| impact of treatments received prior to inclusion in the study on the biological parameters before and on treatment | absolute number / mm 3 of different population of cells and % of cells producing cytokines in the different population of cells will be correlated with treatments received prior to inclusion | antitumor treatment received from diagnosis of melanoma to inclusion |
| correlation between the occurrence of autoimmune side effects and the biological parameters before and on treatment | absolute number / mm 3 of different population of cells and % of cells producing cytokines in the different population of cells will be correlated with autoimmune side effects, based on CTCAE classification | occurence of autoimmune side effects from day 0 to week 54 |
| 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 |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |