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)

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) - Anti-CTLA-4 in the melanoma sentinel node

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39041

Enrollment

Registered

2011-05-12

Start date

2012-03-13

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

melanoma

Interventions

After resection of primary melanoma and seven days before surgery, clinical stage II melanoma patients undergoing a triple-technique SLN procedure will be treated by local i.d. injections, around th

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Stage II melanoma WHO 0-1 performance

Exclusion criteria

Exclusion criteria: no auto-immune disease no immune deficiency

Design outcomes

Primary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)