Clinical trial · Interventional
Characterization of NK Cells Under First Line Advanced Therapy Either as Curative Therapy for Metastatic Melanoma or as Adjuvant Therapy for High-risk of Recurrence
- 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)
Cutaneous melanoma is a tumor with a serious evolution if its initial diagnosis is late. Since 2011, the treatment of advanced forms involves two therapeutic approaches : targeted therapies (BRAF and MEK inhibitors) if the tumor carries a BRAF mutation or immunotherapies (anti-PD1, anti-CTLA-4) regardless of tumor BRAF mutation status. Current data support the hypothesis that combinations of agents targeting the tumor and its environment will be required for durable responses in the majority of patients. Investigators will study the role of NK lymphocytes in tumor immunosurveillance in patients undergoing first-line innovative therapy with metastatic melanoma or at high-risk of recurrence.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples | Other | — | UNRESOLVED |
| Skin biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Group 1: BRAF-mutated metastatic patients treated with 1st line targeted therapy
- description
- BRAF-mutated metastatic patients treated with 1st line targeted therapy
- interventionNames
- Other: Blood samples
- Other: Skin biopsy
- type
- OTHER
- label
- Group 2: Metastatic patients treated with 1st line immunotherapy
- description
- Metastatic patients treated with 1st line immunotherapy
- interventionNames
- Other: Blood samples
- Other: Skin biopsy
- type
- OTHER
- label
- Group 3: BRAF-mutated patients treated with adjuvant targeted therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient ≥ 18 years * Histologically confirmed melanoma patient * Patient for whom treatment by targeted therapy or immunotherapy is prescribed as an adjuvant or curative treatment * In the case of adjuvant treatment, the tumor must be completely removed * Patient included in the Ric-Mel cohort * Patient informed of the objectives and modalities of the study and having received the information form and having given his/her written consent to participate in the research * Patient affiliated to a social security system Exclusion Criteria: * Patient already treated medically for melanoma * Palliative care patient management * Pregnant or breastfeeding women * Patient under guardianship or curatorship * refusal of the patient to participate in the study, or refusal of the patient to allow a portion of his/her previously collected skin sample to be used in the present research
References
Publications (5)
- BACKGROUNDFrazao A, Colombo M, Fourmentraux-Neves E, Messaoudene M, Rusakiewicz S, Zitvogel L, Vivier E, Vely F, Faure F, Dreno B, Benlalam H, Bouquet F, Savina A, Pasmant E, Toubert A, Avril MF, Caignard A. Shifting the Balance of Activating and Inhibitory Natural Killer Receptor Ligands on BRAFV600E Melanoma Lines with Vemurafenib. Cancer Immunol Res. 2017 Jul;5(7):582-593. doi: 10.1158/2326-6066.CIR-16-0380. Epub 2017 Jun 2. PMID 28576831
- BACKGROUNDMartinez EA, Shore A, Colantuoni E, Herzer K, Thompson DA, Gurses AP, Marsteller JA, Bauer L, Goeschel CA, Cleary K, Pronovost PJ, Pham JC. Cardiac surgery errors: results from the UK National Reporting and Learning System. Int J Qual Health Care. 2011 Apr;23(2):151-8. doi: 10.1093/intqhc/mzq084. Epub 2011 Jan 10. PMID 21224272
- BACKGROUNDMessaoudene M, Fregni G, Enot D, Jacquelot N, Neves E, Germaud N, Garchon HJ, Boukouaci W, Tamouza R, Chanal J, Avril MF, Toubert A, Zitvogel L, Rusakiewicz S, Caignard A. NKp30 isoforms and NKp46 transcripts in metastatic melanoma patients: Unique NKp30 pattern in rare melanoma patients with favorable evolution. Oncoimmunology. 2016 Mar 10;5(12):e1154251. doi: 10.1080/2162402X.2016.1154251. eCollection 2016. PMID 28123867
- BACKGROUNDMessaoudene M, Fregni G, Fourmentraux-Neves E, Chanal J, Maubec E, Mazouz-Dorval S, Couturaud B, Girod A, Sastre-Garau X, Albert S, Guedon C, Deschamps L, Mitilian D, Cremer I, Jacquelot N, Rusakiewicz S, Zitvogel L, Avril MF, Caignard A. Mature cytotoxic CD56(bright)/CD16(+) natural killer cells can infiltrate lymph nodes adjacent to metastatic melanoma. Cancer Res. 2014 Jan 1;74(1):81-92. doi: 10.1158/0008-5472.CAN-13-1303. Epub 2013 Nov 13. PMID 24225017
- BACKGROUNDSastre J, Diaz-Beveridge R, Garcia-Foncillas J, Guardeno R, Lopez C, Pazo R, Rodriguez-Salas N, Salgado M, Salud A, Feliu J. Clinical guideline SEOM: hepatocellular carcinoma. Clin Transl Oncol. 2015 Dec;17(12):988-95. doi: 10.1007/s12094-015-1451-3. Epub 2015 Nov 25. PMID 26607931