Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma

NCT03225365 | Completed

• 1 other identifier: 69HCL17_0043
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Melanoma

Keywords

Melanoma; Nivolumab; Ipilimumab; Immune modulation

Outcome Measures

Primary Outcomes (2)

• Change description of biological characteristics of immune cells of the blood by immunomonitoring.

  Biological characteristics description of monocytes, dendritic cell and T cells subpopulations including different circulating suppressive subpopulations 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

• Change in the immune response by skin biopsy.

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

Secondary Outcomes (5)

• Progression-free survival

  Week1 , every radiological assessments defined by standard care (not by specific time frame)

• Overall survival

  week 1, date of patient death

• Auto-immune adverse event frequency

  baseline, week 53 or at the progression

• Subtype of melanoma correlated with biological characteristics of immune cells

  baseline

• Immunity gene polymorphism correlated with biological characteristics of immune cells

  Week 1, week 3, week 7, week 13, week 53 or at the progression.

Study Arms (2)

Nivolumab

OTHER

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

Biological: Blood and biopsy sampling

Nivolumab + Ipilimumab

OTHER

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

Interventions

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.

Nivolumab; Nivolumab + Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Treated haematological malignancies Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
• Patients with autoimmune disease.
• Ocular melanoma

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)

Pierre-Bénite, 69310, France

Location

Related Publications (5)

• Pham FK, Dufeu M, Benboubker V, Grimont M, Lhorisson A, Berthet J, Donzel M, Schneider R, Tonon L, Doffin AC, Boivin F, Durand S, Dubois B, Lopez J, Caux C, Valladeau-Guilemond J, Eberhardt A, Dalle S, Caramel J. Melanoma cell states shape spatial tumor-immune ecosystems to dictate the efficacy of anti-PD1 immunotherapy. J Immunother Cancer. 2026 Jun 18;14(6):e014030. doi: 10.1136/jitc-2025-014030.

  PMID: 42315253 RESULT

• Gobbini E, Hubert M, Doffin AC, Eberhardt A, Hermet L, Li D, Duplouye P, Ghamry-Barrin S, Berthet J, Benboubker V, Grimont M, Sakref C, Perrot J, Tondeur G, Harou O, Lopez J, Dubois B, Dalle S, Caux C, Caramel J, Valladeau-Guilemond J. The Spatial Organization of cDC1 with CD8+ T Cells is Critical for the Response to Immune Checkpoint Inhibitors in Patients with Melanoma. Cancer Immunol Res. 2025 Apr 2;13(4):517-526. doi: 10.1158/2326-6066.CIR-24-0421.

  PMID: 39774795 RESULT

• Benboubker V, Boivin F, Dalle S, Caramel J. Cancer Cell Phenotype Plasticity as a Driver of Immune Escape in Melanoma. Front Immunol. 2022 Mar 29;13:873116. doi: 10.3389/fimmu.2022.873116. eCollection 2022.

  PMID: 35432344 RESULT

• Plaschka M, Benboubker V, Grimont M, Berthet J, Tonon L, Lopez J, Le-Bouar M, Balme B, Tondeur G, de la Fouchardiere A, Larue L, Puisieux A, Grinberg-Bleyer Y, Bendriss-Vermare N, Dubois B, Caux C, Dalle S, Caramel J. ZEB1 transcription factor promotes immune escape in melanoma. J Immunother Cancer. 2022 Mar;10(3):e003484. doi: 10.1136/jitc-2021-003484.

  PMID: 35288462 RESULT

• Dalle S, Verronese E, N'Kodia A, Bardin C, Rodriguez C, Andrieu T, Eberhardt A, Chemin G, Hasan U, Le-Bouar M, Caramel J, Amini-Adle M, Bendriss-Vermare N, Dubois B, Caux C, Menetrier-Caux C. Modulation of blood T cell polyfunctionality and HVEM/BTLA expression are critical determinants of clinical outcome in anti-PD1-treated metastatic melanoma patients. Oncoimmunology. 2024 Jun 26;13(1):2372118. doi: 10.1080/2162402X.2024.2372118. eCollection 2024.

  PMID: 38939518 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 21, 2017
• Study Start: October 10, 2019
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)