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Metastatic MelanomaIMMUNONIVONCT03225365

Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma

A study testing Blood and biopsy sampling in people with Metastatic Melanoma, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
Blood and biopsy sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteFrance
Study dates
10 Oct 2019to 15 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)

    Pierre-Bénite, 69310

Other trials in France

About this study

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

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.

Being tested
Blood and biopsy sampling
Keywords
Melanoma, Nivolumab, Ipilimumab, Immune modulation
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood and biopsy samplingBiological

    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.

Study groups in NCT03225365
Study groupRoleWhat they receive
NivolumabOtherPrevious untreated patient with metastatic melanoma eligible for a Nivolumab treatment. 30 patients will be included in the arm.
Receives: Biological: Blood and biopsy sampling
Nivolumab + IpilimumabOtherPrevious untreated patient with metastatic melanoma eligible for a Nivolumab + Ipilimumab treatment. 30 patients will be included in the arm.
Receives: Biological: Blood and biopsy sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

  2. Change in the immune response by skin biopsy.

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

Secondary outcomes (5)

  1. Progression-free survival

    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

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

  2. Overall survival

    Overall survival (OS) will be calculated as the period of time from the immunotherapy first administration to the patient's death.

    Measured: week 1, date of patient death

  3. Auto-immune adverse event frequency

    Immune adverse event description by clinical examination and correlation with biological characteristics of immune cells

    Measured: baseline, week 53 or at the progression

  4. Subtype of melanoma correlated with biological characteristics of immune cells

    Subtype of melanoma defined by histological analysis correlated with biological characteristics of immune cells

    Measured: baseline

  5. Immunity gene polymorphism correlated with biological characteristics of immune cells

    Immunity gene polymorphism defined by RNA sequencing correlated with biological characteristics of immune cells immune cells

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start10 Oct 2019
  3. Primary completion15 Jun 2021
  4. Study completion15 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03225365
Sponsor's protocol ID
69HCL17_0043
Acronym
IMMUNONIVO
Status last verified
Jul 2026
First submitted
17 Jul 2017
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 42315253

  • 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.

    PubMed 39774795

  • 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.

    PubMed 35432344

  • 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.

    PubMed 35288462

  • 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.

    PubMed 38939518

Questions about this trial

What is this clinical trial studying?

A study testing Blood and biopsy sampling in people with Metastatic Melanoma, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03225365, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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