NCT00972933

Immunogenicity and Biomarker Analysis of Neoadjuvant Ipilimumab for Melanoma

Neoadjuvant Anti-CTLA4 Blockade With Ipilimumab in Patients With AJCC Stage IIIB-C (Tx,1-4, N1b,2b, 2c, 3, M0) Melanoma: Immunogenicity And Biomarker Analysis

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Diwakar Davar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ipilimumab is a manufactured monoclonal antibody, much like the antibodies usually made by the human body to fight off infection; however it is not known why the human body does not "fight off" a cancerous tumor. The idea behind developing this experimental drug is to stimulate the immune system to make antibodies to kill cancer cells. This research study is considered "experimental" because it has not received approval from the Food and Drug Administration (FDA) for the treatment of this type of cancer. This monoclonal antibody has been specifically made to block Cytotoxic T Lymphocyte Antigen 4 (CTLA4), which is a protein found on cells of the immune system. CTLA4 seems to slow down the immune response, so blocking it with an anti-CTLA4 antibody may make the immune response more active. The purpose of this study is to see if Ipilimumab affects the response of the patient's immune system toward their cancer.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	ipilimumab	Excisional Biopsy - baseline Induction ipilimumab 10 mg/kg IV day 0, 21 - baseline and week 3 Complete lymph node dissection - week ≥ 6 Maintenance Ipilimumab 10 mg/kg IV - Days 63 (+28 days) and, 84 (+28 days) - (3 weeks apart, starting 2-4 weeks following definitive lymphadenectomy)

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-07-17
• Completion: 2017-09-26
• First posted: 2009-09-09
• Last updated: 2017-12-07

Locations

1 site across 1 country: United States