This is a multicentric study in which metastatic melanoma patients that have already been treated with at least 2 therapies, will be treated with their own white blood cells that are genetically transduced.

Recruiting

• Conditions: metastasized melanomagemetastaseerde huidkanker

• Registration Number: NL-OMON28054
• Lead Sponsor: KI-AV

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1. Patients must be ≥ 18 years of age;

2. Patients must have inoperable stage IIIc or stage IV cutaneous melanoma (AJCC) progressing after at least two lines of therapy (DTIC, BRAF inhibitor, ipilimumab);

Exclusion Criteria

1. Life expectancy of less than three months;

2. Patients with metastatic ocular melanoma or mucosal melanoma;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Safety (CTCAE 4.0) of the TCR treatment;<br /><br>2. Objective response rate according to RECIST 1.1.

Secondary Outcome Measures

Name	Time	Method
1. 1-year progression free survival (PFS) and median overall survival;<br /><br>2. Efficacy of induction of tumor specific T cell responses (as measured by the persistence of Melan-A/MART1 specific T cells in peripheral blood samples at several time points following adoptive transfer and in tumor biopsies when possible).