Study of CD160, an Activating NK Cell Receptor, in Melanoma: a Potential Therapeutic Target?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Although immunotherapy revolutionized melanoma outcomes over the last 10 years, only 40-50% of patients respond to treatments and 25% develop acquired resistances. Natural Killer (NK) cells naturally recognize and kill tumor cells. However, the immunosuppressive micro-environment generated by the tumor decreases NK cells' killing activity. CD160 is a NK cell receptor identified and characterized in our laboratory. Engagement of the GPI isoform (CD160-GPI) initiates NK cell cytotoxic response. Upon NK cell activation, a transmembrane isoform (CD160-TM) is neo-synthesized which promotes the amplification of activated NK cell cytotoxicity. The aim of this study is to assess the phenotypic profile of advanced stages melanoma patients' NK cells (mainly CD160-TM expression or its induction) and therefore the therapeutic potential of the use of an anti-CD160-TM agonist antibody to boost the NK-dependent mechanism leading to tumor depletion.
Primary outcome measures
- Percentage of effector cells activation and degranulation (CD69 and CD107a staining ) [Time frame: at inclusion]
Secondary outcome measures (12)
- Overall survival [Time frame: at 1 year post inclusion]
- Overall survival [Time frame: at 2 years post inclusion]
- Overall survival [Time frame: at 3 years post inclusion]
- Overall survival [Time frame: at 4 years post inclusion]
- Overall survival [Time frame: at 5 years post inclusion]
- Progression free survival [Time frame: at 1 year]
- Progression free survival [Time frame: at 2 years]
- Progression free survival [Time frame: at 3 years]
- Progression free survival [Time frame: at 4 years]
- Progression free survival [Time frame: at 5 years]
- Objective response rate [Time frame: at one year]
- Objective response rate [Time frame: at 2 years]
Eligibility criteria
Inclusion criteria
- Patients aged18-years old or over
- ECOG score between 0-2
- Inoperable stage III or stage IV melanoma
- Naïve of treatment or in progression after one or several treatment lines
- Give their written consent for the present study and be included in MelBase cohort.
- health insurance coverage.
Supplementary inclusion criteria for part II :
- skin or subcutaneous melanoma lesions
- agree and inform consent for a cutaneous biopsy or a tumor sample if presenting lymph nodes involvement if part of the usual clinical practice.
Exclusion criteria
- Pregnant and breastfeeding women
- Patients with psychiatric disorders
- Patients already included in another clinical trial
- Having received chemotherapy or radiotherapy during the last 4 weeks,
- Patient presenting another solid or blood cancer, chronic viral infection (e.g. HIV, HBV or HCV)
- Been treated with more than 10mg of steroids until the 4 weeks before inclusion.
- Refusal to participate to the study
- Patients under guardianship or curatorship
- Patients on state medical aid
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04477876 · APHP190953