Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma (IMMUNONIVO)

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Melanoma
• Intervention / Treatment: Biological: Blood and biopsy sampling

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Nivolumab; Previous untreated patient with metastatic melanoma eligible for a Nivolumab treatment. 30 patients will be included in the arm.	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.
OTHER: Nivolumab + Ipilimumab; Previous untreated patient with metastatic melanoma eligible for a Nivolumab + Ipilimumab treatment. 30 patients will be included in the arm.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2019
• Primary Completion (ACTUAL): June 15, 2021
• Study Completion (ACTUAL): June 15, 2021

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (ACTUAL): July 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Nivolumab; Melanoma; Ipilimumab; Immune modulation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 69HCL17_0043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No