AzTrials
AzTrials

MelanomaNKCD160MELNCT04477876

Study of CD160, an Activating NK Cell Receptor, in Melanoma: a Potential Therapeutic Target?

An observational study of Melanoma, run by Assistance Publique - Hôpitaux de Paris.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Melanoma
How many people
55 participants
Where
No sites listed yet
Study dates
1 Sep 2020to 15 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Inoperable stage III/ stage IV melanoma patients

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Refusal to participate to the study
  • Patients under guardianship or curatorship
  • Patients on state medical aid

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Celeste Lebbe, Pr contact

01 42 49 99 61

celeste.lebbe@aphp.fr

Matthieu Resche-Rigon, Pr contact

+3342499742

matthieu.resche-rigon@univ-paris-diderot.fr

About this study

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.

Conditions
Melanoma
Medical subject headings
Melanoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of effector cells activation and degranulation (CD69 and CD107a staining )

    Difference between cells incubated with the anti CD160-TM antibody and with isotipic control ab ( flow cytometry)

    Measured: at inclusion

Secondary outcomes (18)

  1. Overall survival

    Measured: at 1 year post inclusion

  2. Overall survival

    Measured: at 2 years post inclusion

  3. Overall survival

    Measured: at 3 years post inclusion

  4. Overall survival

    Measured: at 4 years post inclusion

  5. Overall survival

    Measured: at 5 years post inclusion

  6. Progression free survival

    Measured: at 1 year

  7. Progression free survival

    Measured: at 2 years

  8. Progression free survival

    Measured: at 3 years

  9. Progression free survival

    Measured: at 4 years

  10. Progression free survival

    Measured: at 5 years

  11. Objective response rate

    Measured: at one year

  12. Objective response rate

    Measured: at 2 years

  13. Objective response rate

    Measured: at 3 years

  14. Objective response rate

    Measured: at 4 years

  15. Objective response rate

    Measured: at 5 years

  16. Phenotypic characteristics of NK cells

    Assessment by flow cytometry of the expression levels of activating or inhibitory receptors (e.g. CD160-GPI, NKp46), phenotypic markers (e.g CD16, CD3), as well as activation (CD69) and degranulation (CD107a) markers by the NK cell population (defined as CD3- CD56+ cell). Results will be expressed as the % of positive cells for each marker among the NK cell population

    Measured: at inclusion

  17. cytokine profile

    Assessment by flow cytometry using a cytokine beads array (BD Biosciences) of the Th1/Th2/Th17 cytokine content. The presence of the following cytokine will be assessed: IL17-A, IFN-g, TNF, IL10, IL-6, IL-4 and IL-2. The mean fluorescence intensities will be recorded and quantifications will be done, using an individual standard curve, for each cytokine. Results will be expressed in pg/ml.

    Measured: at inclusion

  18. Détection and quantification of sCD160 in patients' serum

    Measured: at inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study start1 Sep 2020 (estimated)
  3. Primary completion15 Dec 2027 (estimated)
  4. Study completion15 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04477876
Sponsor's protocol ID
APHP190953
Acronym
NKCD160MEL
Status last verified
Feb 2020
First submitted
11 May 2020
Last updated
20 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of 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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 20 Jul 2020. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Celeste Lebbe, Pr (01 42 49 99 61, celeste.lebbe@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of effector cells activation and degranulation (CD69 and CD107a staining ) (time frame: at inclusion). 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 NCT04477876.

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 20 Jul 2020.

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