Releasing the brakes on CD8+ T cells in the melanoma sentinel lymph node by pre-operative local administration of low-dose anti-CTLA-4 (tremelimumab)

Completed

• Conditions: melanoma; 10040900

• Registration Number: NL-OMON39041
• Lead Sponsor: Vrije Universiteit Medisch Centrum

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: 17

Inclusion Criteria

Stage II melanoma
WHO 0-1 performance

Exclusion Criteria

no auto-immune disease
no immune deficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) To determine clinical safety and tolerability of local i.d. administration<br /><br>of a single dose of tremelimumab in Stage II melanoma patients scheduled to<br /><br>undergo a SLN procedure.<br /><br>2) To ascertain the immunological effects of local i.d. injection of<br /><br>tremelimumab on the frequency and functionality of tumor-specific T cells and<br /><br>Tregs -in the SLN and in blood- and on the number and activation state of DC<br /><br>subsets in the SLN. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>