A study of gene therapy in patients with metastatic melanoma

Conditions: Melanoma
MedDRA version: 14.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-002941-36-NL

Lead Sponsor: KI-AV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 25

Inclusion Criteria

Patients must be = 18 years of age.
Patients must have measurable metastatic melanoma
Patients must be HLA-A2 positive.
Patients must have a clinical performance status of ECOG 0 or 1.
Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for four months after receiving the preparative regimen.

Patients must be able to understand and sign the Informed Consent document.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

Life expectancy of less than three months.
Patients with metastatic ocular or mucosal melanoma.
Requirement for systemic steroid therapy.
Patients who have a history of more than two CNS metastases.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the efficacy of this treatment strategy in inducing tumor-specific T cell immunity as measured by the presence of Mart-1 specific T cells in peripheral blood samples on several time points following adoptive transfer.;Secondary Objective: To study the safety of the adoptive transfer of autologous T cells modified with a Mart-1 specific TCR in advanced stage melanoma patients with disease progression upon standard chemotherapy. <br>To study the objective response rate in this patient population.<br>To study the disease-free survival and overall survival.<br>;Primary end point(s): The primary endpoint of this trial is objective reponse rate according to recist 1.1;Timepoint(s) of evaluation of this end point: After 25 patients have received the treatment response rate will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety (CTC 4.0) of the TCR treatment. <br>1-year PFS and median overall survival.<br>Efficacy of induction of tumor specific T cell responses (as measured by the persistence of Mart1 specific T cells in peripheral blood samples at several time points following adoptive transfer and in tumor biopsies when possible).<br>;Timepoint(s) of evaluation of this end point: Safety will be evaluated after 5 patients have been treated, and also at first and the second stage of the study. PFS and efficacy will be evaluated 1 years after the last patient has been treated.