drugset / Trial / NCT04274816

Intradermal Injection of Anti-CTLA-4 in Patients With Stage I/II Melanoma

NCT04274816

Phase 1 Completed 13 enrolled A.J.M. van den Eertwegh
NaSingle-groupOpen-labelTreatment

Summary

This study evaluates the clinical safety and tolerability, and the immunological effects of local intradermal injection of tremelimumab in patients with clinical stage I/II melanoma patients undergoing a sentinel node biopsy (SNB). Patients will be treated by local intradermal injections around the excision site of the primary tumor with escalating doses of 2, 5, 10 or 20 mg tremelimumab.

Timeline

Start
2012-07-10
Primary completion
2014-02-27
Completion
2014-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Tremelimumab Monoclonal antibody 2 mg Intravenous
Subject Tremelimumab Monoclonal antibody 5 mg Intravenous
Subject Tremelimumab Monoclonal antibody 10 mg Intravenous
Subject Tremelimumab Monoclonal antibody 20 mg Intravenous

Indications