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

Civil Hospices of Lyon

Status: Completed

Conditions: Metastatic Melanoma

Treatments: Biological: Blood and biopsy sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT03225365

69HCL17_0043

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Nivolumab

Other group

Description:

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

Treatment:

Biological: Blood and biopsy sampling

Nivolumab + Ipilimumab

Other group

Description:

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

Treatment:

Biological: Blood and biopsy sampling