NCT00688090

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

A Phase 1/2, Open Label, Non-Randomized Dose Escalation Study to Evaluate the Safety, Tolerability, Immune Response and Clinical Response of Multiple Doses of MKC1106-MT in Subjects With Advanced Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on melanomas.

Detailed 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 superficial inguinal lymph nodes under ultrasound guidance.

Conditions

• Advanced Melanoma
• Stage III and IV Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Biological: MKC1106-MT	Cancer Vaccine, Immunotherapy
BIOLOGICAL	Biological: MKCC1106-MT	Cancer Vaccine, Immunotherapy

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-12-01
• Completion: 2010-05-01
• First posted: 2008-06-02
• Last updated: 2010-08-03

Locations

2 sites across 1 country: United States