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A Phase I/II Trial of SCIB1, a DNA Immunotherapy, in the Treatment of Patients With Malignant Melanoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Malignant Melanoma

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Trial Information

A Phase I/II Trial of SCIB1, a DNA Immunotherapy, in the Treatment of Patients With Malignant Melanoma

Inclusion Criteria:

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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Safety & Tolerability

Outcome Description:

Recording and assessment of adverse events to establish safety and tolerability of an investigational immunotherapy, SCIB1, in patients with melanoma whose cancer has spread from the initial tumour (i.e., stage III or stage IV melanoma).

Outcome Time Frame:

Duration of treatment phase: up to 5.5 years

Safety Issue:


Principal Investigator

Poulam M Patel, MD

Investigator Role:

Study Director

Investigator Affiliation:

Department of Clinical Oncology, City Hospital, Nottingham, UK


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

May 2010

Completion Date:

December 2017

Related Keywords:

  • Malignant Melanoma
  • Immunotherapy
  • Melanoma
  • Gene therapy
  • DNA plasmid
  • Cancer vaccine
  • Electroporation
  • CTL response
  • Melanoma