IMMUNONIVO: Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT03225365
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Blood and biopsy sampling
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Immune Modulation Study in Patients With Metastatic Melanoma Treated With a First Line Therapy of Nivolumab +/- Ipilimumab (IMMUNONIVO/MelpredictPD1).
Actual Study Start Date :
Oct 10, 2019
Actual Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Jun 15, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Change in the immune response by skin biopsy. [Week 1 (Baseline), week 7, week 53 or at the progression.]

Secondary Outcome Measures

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL) Pierre-Bénite France 69310

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03225365
Other Study ID Numbers:
  • 69HCL17_0043
First Posted:
Jul 21, 2017
Last Update Posted:
Jan 12, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2022