MelanomaNAKIMELNCT05062096
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
A study testing Blood samples and Skin biopsy in people with Melanoma, run by Assistance Publique - Hôpitaux de Paris.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Blood samples and Skin biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 2 Dec 2023
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Natural Killer (NK) lymphocytes are cytotoxic effectors of the innate immune response that are involved in different phases of tumor immunosurveillance. These lymphocytes are activated upon contact with tumor cells and exert direct cytotoxic activity without prior immunization. Activated NK lymphocytes produce cytokines, including IFN-γ and TNF-α, which induce and maintain an activation of the adaptive immune response by CD8+ lymphocytes. Numerous studies in various experimental tumor models highlight the role of NK cells in the control of metastasis.
Our previous work has shown that NK cells infiltrate primary melanomas, that metastatic patients have altered blood NKs, and furthermore, that chemotherapy modulates their functional status. Investigators also observed a particular distribution of gene polymorphisms encoding NK activating receptors of stage IV melanoma patients compared to healthy donors. Finally, the investigator described a novel population of NK lymphocytes in metastatic lymph nodes draining melanoma NK cell activation is regulated by a balance between activating receptors (NKG2D, NCR) and inhibitory receptors that bind to modulatory classical and non-classical HLA-I molecules (HLA-E and G). More recently it has been shown that Lc NKs also express checkpoint receptors including CD96/TIGIT, NKG2A, TIM3 and PD-1 (the latter 2 are present on LcTs) that negatively modulate NK activation. The possibility of activating the lytic and secretory function of Lc NKs by interfering with these receptors may represent an alternative yet to be explored in immunotherapy treatments.
More recently, th investigator have developed a program to understand the interactions between tumor mutational profile, treatment with targeted therapies and NK immunogenicity. the investigator have a panel of melanoma lines with and without the BRAF V600E mutation and vemurafenib resistant variants have been obtained from some mutated lines. the investigator evaluated the impact of treatment and resistance to BRAF inhibition on Lc NK recognition and lysis. yhe investigator showed that a BRAF inhibitor, vemurafenib, decreased membrane and soluble expression of MICA/B and ULBP2, ligands for NKG2D, an activating receptor present on Lc NKs and certain populations of Lc T cells, in all BRAF mutated lines treated. For 6 of the 7 mutated lines, modulations of NK ligands expression by vemurafenib correlated with a slight decrease in NK cytotoxic functions.
Vemurafenib-resistant (R) variants were generated and their characteristics were compared to those of sensitive (S) lines. The acquisition of resistance to vemurafenib induces a significant increase in NK functions (IFNg secretion and target lysis). The responsible mechanisms involve both the expression of NK receptor ligands and the modulation of death domain receptors (Fas, TRAILRII). Transcriptome analyses reveal different targets of interest in the three pairs of S/R melanoma lines carrying the BRAF V600E mutation and distinct additional mutations (submitted manuscript).
Based on our recent results our hypothesize that Lc NKs are important players in tumor immunosurveillance during current treatments of melanoma patients. Immunotherapy approaches targeting these effectors may be of interest in combinations with targeted therapies or immunotherapies. The frequency of intratumoral Lc NKs has been shown to correlate with the presence of stimulatory dendritic cells and this environment is required for a response to anti-PD1 immunotherapy. Innovative antibodies are being developed to activate the antitumor functions of NK cells
- Conditions
- Melanoma
- Being tested
- Blood samples, Skin biopsy
- Keywords
- melanoma, NK cells, targeted therapies, immunotherapies
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Blood samples at each protocol visit, T and NK cell analysis
Skin biopsyOther
Biopsy of the skin lesion (optional)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: BRAF-mutated metastatic patients treated with 1st line targeted therapy | Other | BRAF-mutated metastatic patients treated with 1st line targeted therapy Receives: Other: Blood samples; Other: Skin biopsy |
| Group 2: Metastatic patients treated with 1st line immunotherapy | Other | Metastatic patients treated with 1st line immunotherapy Receives: Other: Blood samples; Other: Skin biopsy |
| Group 3: BRAF-mutated patients treated with adjuvant targeted therapy | Other | BRAF-mutated patients treated with adjuvant targeted therapy Receives: Other: Blood samples; Other: Skin biopsy |
| Group 4: Patients treated with adjuvant immunotherapy | Other | Patients treated with adjuvant immunotherapy Receives: Other: Blood samples; Other: Skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
NK cells are recovered from blood samples taken at 2-3 months to 6 of treatment Late changes from Month2-Month 3 to Month 6 in the expression of membrane or soluble markers of NK or LcT cells during treatment and according to treatment groups (targeted therapy or immunotherapy used in a curative or an adjuvant setting).
Measured: From Mont 2-Month 3 to Mmonth 6
Evaluate the association between soluble or membrane markers modified during treatment and clinical evolution
analysis of soluble or membrane markers altered during treatment as a function of responders and non-responders according to RECIST 1.1 criteria.
Measured: 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
Tumor biopsy analysis to Identification of tumor markers or combination of tumor markers whose expression is associated with response or resistance to therapy according to RECIST 1.1. If sequential biopsies are obtained in patients with skin metastases, investigation of an association between tumor phenotype in the microenvironment at S3-S4 of treatment and response to treatment
Measured: 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
Blood analysis evaluat soluble and membrane markers at baseline and during treatment as a function of treatment response
Measured: Before the start of treatment
Comparison of soluble or membrane markers modified according to the treatment
Cellular analysis to see modification of the expression of membrane markers (+/- 30% of expression of the marker or Mean Fluorescence) or soluble markers (+/- 20% of expression of the marker) of NK or LcT cells during the treatment and according to the treatment received: targeted therapy or immunotherapy
Measured: During treatment up to 6 months
Comparison of soluble or membrane markers modified according to the presence or not of metastasis
Cellular analysis to study modification of the expression of membrane markers (+/- 30% of expression of the marker or of the Mean Fluorescence) or soluble markers (+/- 20% of expression of the marker) of NK or LcT cells during the treatment and according to the presence or not of metastasis at the inclusion
Measured: During treatment up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Nov 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion2 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Société de Dermatologie Française
- Responsible party
- Sponsor
- Investigators
- Eve Maubec, PhD, Principal investigator, Assistance Public Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062096
- Sponsor's protocol ID
- APHP200196
- Acronym
- NAKIMEL
- Status last verified
- Sep 2022
- First submitted
- 17 May 2021
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28576831Martinez 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.
PubMed 21224272Messaoudene 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.
PubMed 28123867Messaoudene 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.
PubMed 24225017Sastre 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.
PubMed 26607931
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05062096
- Acronym / sponsor ID
- NAKIMEL / APHP200196
- Conditions
- Melanoma
- Keywords
- melanoma, NK cells, targeted therapies, immunotherapies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Société de Dermatologie Française
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 2 Dec 2023 (estimated)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Natural Killer (NK) lymphocytes are cytotoxic effectors of the innate immune response that are involved in different phases of tumor immunosurveillance. These lymphocytes are activated upon contact with tumor cells and exert direct cytotoxic activity without prior immunization. Activated NK lymphocytes produce cytokines, including IFN-γ and TNF-α, which induce and maintain an activation of the adaptive immune response by CD8+ lymphocytes. Numerous studies in various experimental tumor models highlight the role of NK cells in the control of metastasis.
Our previous work has shown that NK cells infiltrate primary melanomas, that metastatic patients have altered blood NKs, and furthermore, that chemotherapy modulates their functional status. Investigators also observed a particular distribution of gene polymorphisms encoding NK activating receptors of stage IV melanoma patients compared to healthy donors. Finally, the investigator described a novel population of NK lymphocytes in metastatic lymph nodes draining melanoma NK cell activation is regulated by a balance between activating receptors (NKG2D, NCR) and inhibitory receptors that bind to modulatory classical and non-classical HLA-I molecules (HLA-E and G). More recently it has been shown that Lc NKs also express checkpoint receptors including CD96/TIGIT, NKG2A, TIM3 and PD-1 (the latter 2 are present on LcTs) that negatively modulate NK activation. The possibility of activating the lytic and secretory function of Lc NKs by interfering with these receptors may represent an alternative yet to be explored in immunotherapy treatments.
More recently, th investigator have developed a program to understand the interactions between tumor mutational profile, treatment with targeted therapies and NK immunogenicity. the investigator have a panel of melanoma lines with and without the BRAF V600E mutation and vemurafenib resistant variants have been obtained from some mutated lines. the investigator evaluated the impact of treatment and resistance to BRAF inhibition on Lc NK recognition and lysis. yhe investigator showed that a BRAF inhibitor, vemurafenib, decreased membrane and soluble expression of MICA/B and ULBP2, ligands for NKG2D, an activating receptor present on Lc NKs and certain populations of Lc T cells, in all BRAF mutated lines treated. For 6 of the 7 mutated lines, modulations of NK ligands expression by vemurafenib correlated with a slight decrease in NK cytotoxic functions.
Vemurafenib-resistant (R) variants were generated and their characteristics were compared to those of sensitive (S) lines. The acquisition of resistance to vemurafenib induces a significant increase in NK functions (IFNg secretion and target lysis). The responsible mechanisms involve both the expression of NK receptor ligands and the modulation of death domain receptors (Fas, TRAILRII). Transcriptome analyses reveal different targets of interest in the three pairs of S/R melanoma lines carrying the BRAF V600E mutation and distinct additional mutations (submitted manuscript).
Based on our recent results our hypothesize that Lc NKs are important players in tumor immunosurveillance during current treatments of melanoma patients. Immunotherapy approaches targeting these effectors may be of interest in combinations with targeted therapies or immunotherapies. The frequency of intratumoral Lc NKs has been shown to correlate with the presence of stimulatory dendritic cells and this environment is required for a response to anti-PD1 immunotherapy. Innovative antibodies are being developed to activate the antitumor functions of NK cells
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: BRAF-mutated metastatic patients treated with 1st line targeted therapy | Other | Other: Blood samples, Other: Skin biopsyBRAF-mutated metastatic patients treated with 1st line targeted therapy |
| Group 2: Metastatic patients treated with 1st line immunotherapy | Other | Other: Blood samples, Other: Skin biopsyMetastatic patients treated with 1st line immunotherapy |
| Group 3: BRAF-mutated patients treated with adjuvant targeted therapy | Other | Other: Blood samples, Other: Skin biopsyBRAF-mutated patients treated with adjuvant targeted therapy |
| Group 4: Patients treated with adjuvant immunotherapy | Other | Other: Blood samples, Other: Skin biopsyPatients treated with adjuvant immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesBlood samples at each protocol visit, T and NK cell analysis | Other | Group 1: BRAF-mutated metastatic patients treated with 1st line targeted therapy, Group 2: Metastatic patients treated with 1st line immunotherapy, Group 3: BRAF-mutated patients treated with adjuvant targeted therapy, Group 4: Patients treated with adjuvant immunotherapy |
| Skin biopsyBiopsy of the skin lesion (optional) | Other | Group 1: BRAF-mutated metastatic patients treated with 1st line targeted therapy, Group 2: Metastatic patients treated with 1st line immunotherapy, Group 3: BRAF-mutated patients treated with adjuvant targeted therapy, Group 4: Patients treated with adjuvant immunotherapy |
Primary outcome
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.
Time frame: Before the start of treatment and after 3-4 weeks
NK cells are recovered from blood samples taken before the start of treatment and after 3-4 weeks
6 secondary outcomes
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.
Time frame: From Mont 2-Month 3 to Mmonth 6
Evaluate the association between soluble or membrane markers modified during treatment and clinical evolution
Time frame: 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
Time frame: 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
Time frame: Before the start of treatment
Comparison of soluble or membrane markers modified according to the treatment
Time frame: During treatment up to 6 months
Comparison of soluble or membrane markers modified according to the presence or not of metastasis
Time frame: During treatment up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Background: PubMed 28576831Frazao 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.
- Background: PubMed 21224272Martinez 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.
- Background: PubMed 28123867Messaoudene 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.
- Background: PubMed 24225017Messaoudene 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.
- Background: PubMed 26607931Sastre 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.
- Minimally Invasive Treatments for Liver Cancer, Updates in Liver CancerLink provided by the sponsor.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eve Maubec, PhD principal investigator
Assistance Public Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples and Skin biopsy in people with Melanoma, run by Assistance Publique - Hôpitaux de Paris.
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 5 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: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eve Maubec, PhD (01.48.95.70.90, eve.maubec@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Before the start of treatment and after 3-4 weeks). 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 NCT05062096, 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 4 Oct 2022.