NCT04477876Not yet recruiting
Study of CD160, an Activating NK Cell Receptor, in Melanoma: a Potential Therapeutic Target?
Source: ClinicalTrials.gov · Last updated 20 Jul 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 55 (estimated)
- First submitted
- 11 May 2020
- Start date
- 1 Sept 2020
- Primary completion date
- 15 Dec 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Melanoma
- NCT number
- NCT04477876
What you commit to
- Study type: Observational
- Planned participants: 55
- From 1 Sept 2020 to the primary completion date, 15 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having received chemotherapy or radiotherapy during the last 4 weeks,
- Been treated with more than 10mg of steroids until the 4 weeks before inclusion.
Other illness
- Patients with psychiatric disorders
- Patient presenting another solid or blood cancer, chronic viral infection (e.g. HIV, HBV or HCV)
Other
- Pregnant and breastfeeding women
- Patients already included in another clinical trial
- Refusal to participate to the study
- Patients under guardianship or curatorship
- Patients on state medical aid
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.