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

Phase 2

Terminated

Conditions: Stage III Melanoma
Stage IV Melanoma

Registration Number: NCT01026051

Lead Sponsor: Mannkind Corporation

Brief 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

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 non-diseased superficial inguinal lymph nodes under ultrasound guidance

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5

Inclusion Criteria

Histologically confirmed diagnosis of regional or distant metastatic melanoma (stage IIIB, IIIC, or IV) confined to skin, subcutaneous tissue, or lymph nodes that is refractory to standard of care, or for which no curative standard therapy exists (Note: Subjects who are therapy-naïve will also be eligible.)
Measurable disease by the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria
ECOG performance status of 0 or 1
Life expectancy > or = 3 months
18 years of age or older at screening evaluation
Subjects must be able to provide informed consent for participation in the clinical trial before any protocol-specific clinical trial procedure is performed
Positive for HLA-A2 and, more precisely, for expression of A*0201 as assessed by DNA typing
Tumor material from prior biopsy/surgical resection available for analysis of expression of melanoma specific antigens
Adequate coagulation function as evidenced by prothrombin time (PT) and partial thromboplastin time (PTT) values within the normal range
Adequate bone marrow reserve as evidenced by Absolute neutrophil count (ANC) > or = 1,000/mL; platelet count > or = 75,000/mL
Subjects must have recovered to at least baseline or Grade 1 toxicity from the effects of any prior surgery, radiotherapy, or other therapies including but not limited to chemotherapy
Women of childbearing potential as well as fertile men and their partners must agree to use an effective method of contraception or to abstain from sexual intercourse during the clinical trial and for 90 days following the last dose of the investigational drug.
Subjects who have received local radiation therapy (less than one-fourth of bone marrow) are eligible.

Exclusion Criteria

Subjects with visceral metastasis (Note: Subjects with stable CNS metastasis or fully treated CNS metastatic disease [eg, radiation therapy] are eligible.)
Active infection requiring treatment
Systemic inflammatory disease requiring chronic maintenance or suppressive therapy
Positive antibody test result for HIV, hepatitis B, or hepatitis C
History of allogeneic transplant
Medical, sociological, or psychological conditions that may compromise compliance or participation or that may interfere with the interpretation of the results
History of receiving immunosuppressive drugs within 1 month before dosing
Subjects who are lactating, pregnant, or planning to become pregnant within 3 months of completing treatment
Subjects who received an investigational drug within the 4 weeks before dosing
Prior systemic radiation therapy (more than one-fourth of bone marrow)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To assess clinical efficacy of MKC1106-MT in subjects with advanced melanoma measured at 6 months and 1 year by (1) time to progression, progression-free survival	12 Months
To identify and characterize correlations between biological activity (immune response), target antigen expression and clinical efficacy.	12 months
To further assess the safety profile and tolerability	12 months

Trial Locations

Locations (4): The Angeles Clinic and Research Institute
🇺🇸
Los Angeles, California, United States
UCLA Medical Center
🇺🇸
Los Angeles, California, United States
Martin Memorial
🇺🇸
Stuart, Florida, United States
Nevada Cancer Institute
🇺🇸
Las Vegas, Nevada, United States