A Phase I/II Trial of SCIB1, a DNA Immunotherapy, in the Treatment of Patients With Malignant Melanoma
Part One only:
- Histologically confirmed Stage IV or Stage III malignant melanoma, as defined by the
American Joint Committee on Cancer (AJCC).
- Must have measurable disease (RECIST 1.0)
Part Two only:
- Histologically confirmed, resected Stage III or resected Stage IV malignant melanoma,
as defined by the AJCC, within 12 months of resection and with no tumour detectable
at the time of screening.
Part One and Part Two:
- HLA-A2 positive.
- Positive for HLA-DR4, HLA-DR7, HLA-DR53 or HLA-DQ6.
- Lymphocyte count ≥ 500,000 cells/mL.
- Serum lactate dehydrogenase (LDH) ≤ upper limit of normal.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Willing and able to give written, informed consent.
- If male or female of childbearing potential, must be willing to use an effective
contraceptive during the course of the study and for three months afterwards.
- Known brain metastases at screening.
- Life expectancy of less than three months.
- Patients with TNM classification M1c at screening.
- Prior systemic anti-cancer treatment within four weeks of screening.
- Prior treatment with systemic corticosteroids or other immunosuppressants within four
weeks of screening.
- Previous (within five years) or current malignancy at other sites with the exception
of curatively treated local tumours such as carcinoma-in-situ of the cervix, basal or
squamous cell carcinoma of the skin.
- Pregnant or lactating women.
- Presence of any uncontrolled and significant medical or psychiatric condition which
would interfere with trial safety assessments. Caution should be used for patients
with suspected or diagnosed epilepsy.
- Any electronic stimulation device such as cardiac demand pacemaker, automatic
implantable cardiac defibrillator, nerve stimulators or deep brain stimulators.
- Individuals in which a skin-fold measurement of the cutaneous and subcutaneous tissue
for all eligible injection sites (deltoid or quadriceps muscles with intact lymph
drainage) exceeds 40 mm.
- Individuals with a heart rate of ≤ 50 beats per minute, history of significant
cardiac abnormality and/or significant abnormal baseline electrocardiogram (ECG)
- Treatment with any investigational product within the four weeks preceding screening.