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

Civil Hospices of Lyon logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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