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
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the objective response, where response is defined as either complete response (CR), partial response (PR), or stable disease (SD) for 12 weeks or longer (CR, PR, and SD are defined according to RECIST 1.1 criteria)
12 Months
No
Chief Scientific Officer
Study Chair
Mannkind Corporation
United States: Food and Drug Administration
MKC1106-MT-002
NCT01026051
October 2010
July 2012
Name | Location |
---|---|
UCLA Medical Center | Los Angeles, California 90095-7059 |
Nevada Cancer Institute | Las Vegas, Nevada 89135 |
The Angeles Clinic and Research Institute | Los Angeles, California 90025 |
Martin Memorial | Stuart, Florida 34994 |