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
NAKIMEL
1 other identifier
interventional
220
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
September 30, 2021
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2023
CompletedOctober 4, 2022
September 1, 2022
1.1 years
May 17, 2021
October 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
characterize lymphoid cells, in particular NK lymphocytes, LcTs before and during a first line of curative or adjuvant treatment by targeted therapy or immunotherapy in order to identify early markers of response/resistance to treatment.
NK cells are recovered from blood samples taken before the start of treatment and after 3-4 weeks
Before the start of treatment and after 3-4 weeks
Secondary Outcomes (6)
Characterize lymphoid cells before and during a first line of curative or adjuvant treatment with targeted therapy or immunotherapy to identify late markers of response/resistance to treatment.
From Mont 2-Month 3 to Mmonth 6
Evaluate the association between soluble or membrane markers modified during treatment and clinical evolution
During treatment up to 6 month
Immunohistochemical analysis of markers of interest on primary tumors and/or metastases at baseline and during treatment if possible and according to the response to treatment
Before the start of treatment and during treatment up to 6 month
Assess the predictive capacity of soluble tumor markers in blood cells before the beginning of the treatment on the clinical evolution
Before the start of treatment
Comparison of soluble or membrane markers modified according to the treatment
During treatment up to 6 months
- +1 more secondary outcomes
Study Arms (4)
Group 1: BRAF-mutated metastatic patients treated with 1st line targeted therapy
OTHERBRAF-mutated metastatic patients treated with 1st line targeted therapy
Group 2: Metastatic patients treated with 1st line immunotherapy
OTHERMetastatic patients treated with 1st line immunotherapy
Group 3: BRAF-mutated patients treated with adjuvant targeted therapy
OTHERBRAF-mutated patients treated with adjuvant targeted therapy
Group 4: Patients treated with adjuvant immunotherapy
OTHERPatients treated with adjuvant immunotherapy
Interventions
Blood samples at each protocol visit, T and NK cell analysis
Biopsy of the skin lesion (optional)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Frazao 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: 28576831BACKGROUNDMartinez 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: 21224272BACKGROUNDMessaoudene 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: 28123867BACKGROUNDMessaoudene 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: 24225017BACKGROUNDSastre 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: 26607931BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eve Maubec, PhD
Assistance Public Hôpitaux de Paris
Central Study Contacts
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
May 17, 2021
First Posted
September 30, 2021
Study Start
November 1, 2022
Primary Completion
December 1, 2023
Study Completion
December 2, 2023
Last Updated
October 4, 2022
Record last verified: 2022-09