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

• Status: Completed
• Trial end date: 2014-02-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: A.J.M. van den Eertwegh
• Treatments: Antibodies, Monoclonal; Tremelimumab

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Clinical stage I/II melanoma patients, planned to undergo a sentinel lymph node biopsy (SNB)

• ECOG performance status 0 or 1

• White blood count (WBC) ≥ 3 x10^9/L

• Platelet count ≥ 100 x10^9/L

• Hemoglobin ≥ 6.5 mmol/L

• Serum creatinine ≤ 2.5 x ULN

• Total serum bilirubin, AST, ALT and LDH ≤ 2x ULN

Exclusion Criteria:

• Non-oncology vaccine therapy used for prevention of infectious diseases (up-to) 4 weeks prior and/r 8 weeks after any dose of tremelimumab

• Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist

• Uncontrolled infectious disease including negative testing for HIV, HBV, HCV

• Autoimmune disease