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

Primary Purpose

Metastatic Melanoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood and biopsy sampling
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metastatic Melanoma focused on measuring Melanoma, Nivolumab, Ipilimumab, Immune modulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Nivolumab

Nivolumab + Ipilimumab

Arm Description

Previous untreated patient with metastatic melanoma eligible for a Nivolumab treatment. 30 patients will be included in the arm.

Previous untreated patient with metastatic melanoma eligible for a Nivolumab + Ipilimumab treatment. 30 patients will be included in the arm.

Outcomes

Primary Outcome Measures

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
Change in the immune response by skin biopsy.

Secondary Outcome Measures

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
Overall survival
Overall survival (OS) will be calculated as the period of time from the immunotherapy first administration to the patient's death.
Auto-immune adverse event frequency
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
Subtype of melanoma defined by histological analysis correlated with biological characteristics of immune cells
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

Full Information

First Posted
July 17, 2017
Last Updated
December 23, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03225365
Brief Title
Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma
Acronym
IMMUNONIVO
Official Title
Immune Modulation Study in Patients With Metastatic Melanoma Treated With a First Line Therapy of Nivolumab +/- Ipilimumab (IMMUNONIVO/MelpredictPD1).
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
Melanoma, Nivolumab, Ipilimumab, Immune modulation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab
Arm Type
Other
Arm Description
Previous untreated patient with metastatic melanoma eligible for a Nivolumab treatment. 30 patients will be included in the arm.
Arm Title
Nivolumab + Ipilimumab
Arm Type
Other
Arm Description
Previous untreated patient with metastatic melanoma eligible for a Nivolumab + Ipilimumab treatment. 30 patients will be included in the arm.
Intervention Type
Biological
Intervention Name(s)
Blood and biopsy sampling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change description of biological characteristics of immune cells of the blood by immunomonitoring.
Description
Biological characteristics description of monocytes, dendritic cell and T cells subpopulations including different circulating suppressive subpopulations by immunomonitoring
Time Frame
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
Title
Change in the immune response by skin biopsy.
Time Frame
Week 1 (Baseline), week 7, week 53 or at the progression.
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
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
Time Frame
Week1 , every radiological assessments defined by standard care (not by specific time frame)
Title
Overall survival
Description
Overall survival (OS) will be calculated as the period of time from the immunotherapy first administration to the patient's death.
Time Frame
week 1, date of patient death
Title
Auto-immune adverse event frequency
Description
Immune adverse event description by clinical examination and correlation with biological characteristics of immune cells
Time Frame
baseline, week 53 or at the progression
Title
Subtype of melanoma correlated with biological characteristics of immune cells
Description
Subtype of melanoma defined by histological analysis correlated with biological characteristics of immune cells
Time Frame
baseline
Title
Immunity gene polymorphism correlated with biological characteristics of immune cells
Description
Immunity gene polymorphism defined by RNA sequencing correlated with biological characteristics of immune cells immune cells
Time Frame
Week 1, week 3, week 7, week 13, week 53 or at the progression.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma

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