Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-10

Study Completion Date

2021-06-15

Brief Summary

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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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Detailed Description

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Conditions

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Metastatic Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Nivolumab

Previous untreated patient with metastatic melanoma eligible for a Nivolumab treatment.

30 patients will be included in the arm.

Group Type OTHER

Blood and biopsy sampling

Intervention Type 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.

Nivolumab + Ipilimumab

Previous untreated patient with metastatic melanoma eligible for a Nivolumab + Ipilimumab treatment.

30 patients will be included in the arm.

Group Type OTHER

Blood and biopsy sampling

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No