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NCT Number: NCT03225365

Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma

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.

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Key information

Conditions

Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and biopsy sampling

Biological

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 outcomes

  1. Change description of biological characteristics of immune cells of the blood 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

    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.

    Time frame: Week 1 (Baseline), week 7, week 53 or at the progression.

Secondary outcomes

  1. Progression-free survival

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: IMMUNONIVO

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2017
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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