Multicenter phase I/IIa study using T-cell receptor gene therapy in metastatic melanoma

Phase 2

Completed

• Conditions: maligne melanoma; skin cancer; uveal melanoma; 10030054; 10040900

• Registration Number: NL-OMON47165
• Lead Sponsor: ederlands Kanker Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Patients must be >= 18 years of age.
Patients must have inoperable stage IIIc or stage IV cutaneous melanoma (AJCC), including ocular or mucosal melanoma, progressing after standard of care therapy
Patients must be HLA-A2 positive.
The primary tumor and/or metastasis have to be positive for MART-1
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.

Exclusion Criteria

Life expectancy of less than three months.
Requirement for systemic steroid therapy.
Patients who have a history of CNS metastases.
Patients with pleural effusion or ascites.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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