Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma

Not Applicable

Completed

• Conditions: Metastatic Melanoma
• Interventions: Biological: Blood and biopsy sampling

• Registration Number: NCT03225365
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Study Start: 2019-10-10
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2022-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Men and women aged ≥ 18 years of age.
• Patient with metastatic or unresectable melanoma
• Nivolumab or Nivolumab + Ipilimumab treatment indication
• Skin biopsies available
• Patient affiliated to or a beneficiary of a social security category.
• Signed Written Informed Consent.
• Patient who agrees to the storage of his biological samples

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Exclusion Criteria

• Treated haematological malignancies Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
• Patients with autoimmune disease.
• Ocular melanoma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nivolumab	Blood and biopsy sampling	Previous untreated patient with metastatic melanoma eligible for a Nivolumab treatment. 30 patients will be included in the arm.
Nivolumab + Ipilimumab	Blood and biopsy sampling	Previous untreated patient with metastatic melanoma eligible for a Nivolumab + Ipilimumab treatment. 30 patients will be included in the arm.

Primary Outcome Measures

Name	Time	Method
Change in the immune response by skin biopsy.	Week 1 (Baseline), week 7, week 53 or at the progression.
Change description of biological characteristics of immune cells of the blood 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	Biological characteristics description of monocytes, dendritic cell and T cells subpopulations including different circulating suppressive subpopulations by immunomonitoring

Secondary Outcome Measures

Name	Time	Method
Overall survival	week 1, date of patient death	Overall survival (OS) will be calculated as the period of time from the immunotherapy first administration to the patient's death.
Progression-free survival	Week1 , every radiological assessments defined by standard care (not by specific time frame)	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
Auto-immune adverse event frequency	baseline, week 53 or at the progression	Immune adverse event description by clinical examination and correlation with biological characteristics of immune cells
Subtype of melanoma correlated with biological characteristics of immune cells	baseline	Subtype of melanoma defined by histological analysis correlated with biological characteristics of immune cells
Immunity gene polymorphism correlated with biological characteristics of immune cells	Week 1, week 3, week 7, week 13, week 53 or at the progression.	Immunity gene polymorphism defined by RNA sequencing correlated with biological characteristics of immune cells immune cells

Trial Locations

Locations (1)

Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL); 🇫🇷 Pierre-Bénite, France