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

Not Applicable

• Conditions: Melanoma (Skin)
• Interventions: Other: Development of the most specific physiologically relevant experimental patient models

• Registration Number: NCT03136783
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-22
• Status Verified: 2017-04
• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-04-28
• Last Update Submitted: 2017-04-28
• Study First Posted: 2017-05-02
• Last Update Posted: 2017-05-02
• Primary Completion: 2019-09-22
• Study Completion: 2019-09-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with stage IV melanoma	Development of the most specific physiologically relevant experimental patient models	-

Primary Outcome Measures

Name	Time	Method
Evaluating in vitro the response of tumor cells to different combinations of targeted therapy molecules	30 months

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France