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New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy

New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03136783
Acronym
SkinTher
Enrollment
1
Registered
2017-05-02
Start date
2018-04-05
Completion date
2025-10-27
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Brief summary

The choice of treatment of patients with metastatic melanoma depends on the status of B-RAF of the tumor: in the absence of mutation, treatment with immunotherapy (currently anti-PD1) is proposed in the first line; When B-RAF is mutated, treatment with targeted therapies is retained: B-RAF and MEK inhibitors are prescribed in combination (vemurafenib + cobimetinib or dabrafenib + trametinib). Patient response rates for targeted therapies range from 50 to 60%, and the occurrence of sometimes severe side effects is not predictable. There are currently no predictive biomarkers of patients' response to targeted therapy molecules. The in vitro evaluation of the intrinsic sensitivity of the cells of patients to different combinations of targeted therapy molecules would make it possible to propose the best therapeutic combinations. The cutaneous metastases are chosen in the model because of easy access to collect tumor tissue. The most relevant in vitro models for mimicking cutaneous melanoma metastases are explant cultures and human skin equivalents.

Interventions

OTHERDevelopment of the most specific physiologically relevant experimental patient models

Development of the most specific physiologically relevant experimental patient models: organotypic culture of biopsies, reconstituted skin (equivalents of dermis with melanoma, dermis equivalents and epidermis with melanoma), and in vitro evaluation The response of tumor cells to different combinations of targeted therapy molecules

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Major Patients, * patients with melanoma (stage IV) with cutaneous metastases, * seronegative HIV, HBV, HCV, HTLV1.

Exclusion criteria

* Absence of cutaneous metastasis or in transit * HIV or HBV or HCV or HTLV1 seropositivity * Patient minor, patient under guardianship or curatorship

Design outcomes

Primary

MeasureTime frame
Evaluating in vitro the response of tumor cells to different combinations of targeted therapy molecules30 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026