Clinical trial · Interventional
Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma
Immune Modulation Study in Patients With Metastatic Melanoma Treated With a First Line Therapy of Nivolumab +/- Ipilimumab (IMMUNONIVO/MelpredictPD1).
NCT03225365CI-TRIAL-00118549IMMUNONIVOcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood and biopsy sampling | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Nivolumab
- description
- Previous untreated patient with metastatic melanoma eligible for a Nivolumab treatment. 30 patients will be included in the arm.
- interventionNames
- Biological: Blood and biopsy sampling
- type
- OTHER
- label
- Nivolumab + Ipilimumab
- description
- Previous untreated patient with metastatic melanoma eligible for a Nivolumab + Ipilimumab treatment. 30 patients will be included in the arm.
- interventionNames
- Biological: Blood and biopsy sampling
Primary outcomes (2)
- measure
- Change description of biological characteristics of immune cells of the blood by immunomonitoring.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- RESULTPham 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
- RESULTGobbini 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
- RESULTBenboubker 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
- RESULTPlaschka 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
- RESULTDalle 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