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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

Phase 2
18 Years
Not Enrolling
Stage III Melanoma, Stage IV Melanoma

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Trial Information

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

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

- 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

- 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)

Type of Study:


Study Design:

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

Outcome Measure:

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)

Outcome Time Frame:

12 Months

Safety Issue:


Principal Investigator

Chief Scientific Officer

Investigator Role:

Study Chair

Investigator Affiliation:

Mannkind Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

October 2010

Completion Date:

July 2012

Related Keywords:

  • Stage III Melanoma
  • Stage IV Melanoma
  • Cancer Vaccine, Immunotherapy, Melanoma
  • Melanoma



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