Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma

Metastatic Melanoma Clinical Trial

— IMMUNONIVO  

Official title:

Immune Modulation Study in Patients With Metastatic Melanoma Treated With a First Line Therapy of Nivolumab +/- Ipilimumab (IMMUNONIVO/MelpredictPD1).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225365
• Other study ID #: 69HCL17_0043
• Status: Completed
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: June 15, 2021

Study information

• Verified date: December 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Biological:
• Blood and biopsy sampling
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.

Locations

Country	Name	City	State
France	Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in the immune response by skin biopsy.		Week 1 (Baseline), week 7, week 53 or at the progression.
Secondary	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)
Secondary	Overall survival	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
Secondary	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
Secondary	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
Secondary	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.