Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma

Stage IV Melanoma Clinical Trial

Official title: A Phase 2, Open Label, Non-Randomized Study to Evaluate the Safety, Tolerability, Immune Response and Clinical Response of Multiple Doses of MKC1106-MT in Subjects With Advanced Melanoma

Status Terminated

Clinical Trial Summary

The clinical trial is evaluating a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on melanoma

Clinical Trial Description

The multi-component active immunotherapy, MKC1106-MT, consists of 1 plasmid dose and 2 peptides doses designed to stimulate an immune reaction to two tumor associated antigens (Melan-A and tyrosinase). The plasmid component will be administered on Days 1, 4, 15 and 18 of each treatment cycle followed by administration of peptides on Days 29 and 32 of the treatment cycle. All components will be administered separately into non-diseased superficial inguinal lymph nodes under ultrasound guidance ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Stage III Melanoma
• Stage IV Melanoma

• NCT number: NCT01026051
• Study type: Interventional
• Source: Mannkind Corporation
• Status: Terminated
• Phase: Phase 2
• Start date: October 2010
• Completion date: July 2012