Know Cancer

forgot password

Randomized, Double-blind Phase II Trial of NY-ESO-1 ISCOMATRIX® Vaccine and ISCOMATRIX® Adjuvant Alone in Patients With Resected Stage IIc, III or IV Malignant Melanoma

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

Randomized, Double-blind Phase II Trial of NY-ESO-1 ISCOMATRIX® Vaccine and ISCOMATRIX® Adjuvant Alone in Patients With Resected Stage IIc, III or IV Malignant Melanoma

NY-ESO-1 protein is an immune target found in many cancers including melanoma. ISCOMATRIX®
adjuvant enhances immune responses. This trial compares NY-ESO-1 ISCOMATRIX® vaccine with
ISCOMATRIX® adjuvant alone to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine
improves outcomes for participants with Malignant Melanoma which has been removed, but is at
high risk of recurrence.

Eligible participants are randomly allocated to a treatment arm. Treatment involves four
intramuscular (into a muscle) injections (1 injection every 4 weeks x 3, plus 1 injection at
6 months).

Participants are assessed for recurrence of melanoma, safety and immune responses (by blood
test) over the 18 month study period. Off study, their own doctor will follow them for
melanoma recurrence and survival.

Inclusion Criteria:

- Histologically proven malignant melanoma.

- Tumor expression of NY-ESO-1 antigen by immunohistochemistry.

- Fully resected AJCC stage IIc, IIIb, IIIc or IV melanoma.

- Within six months of surgery for melanoma.

- Full recovery from surgery.

- No immunotherapy or systemic adjuvant therapy for melanoma since most recent relapse
and/or resection. (Previous adjuvant therapy accepted providing pt relapsed and
resected after this.)

- Age 18 years or older.

- Able to give written informed consent.

- Vital laboratory parameters within normal range, or protocol specified ranges.

Exclusion Criteria:

- Other serious or significant illnesses.

- Resected cerebral metastases.

- Ocular melanoma.

- Other malignancy within last 3 years, except for treated non-melanoma skin cancer and
cervical cancer in situ.

- Using immunosuppressive drugs.

- Anticoagulation.

- Known HIV positivity.

- Chemotherapy or radiation therapy in last four weeks (6 weeks for nitrosourea drugs).

- Not available for immunological and clinical follow-up assessments.

- Participation in prior clinical trial involving an investigational agent within last
4 weeks.

- Previous isolated limb perfusion (ILP).

- Pregnancy or breastfeeding.

- Refusal or inability to use effective means of contraception for women of
childbearing potential.

- Mental impairment that may compromise ability to give informed consent and to comply
with study requirements.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

- Rate of Relapse-free Survival at 18 months.

Outcome Time Frame:

18 months

Principal Investigator

Prof. Jonathan S Cebon, MBBS PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Ludwig Institute for Cancer Research


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

September 2005

Completion Date:

December 2011

Related Keywords:

  • Melanoma
  • Phase II
  • Randomized Controlled Trial
  • Double-Blind
  • Cancer Vaccine
  • NY-ESO-1 protein, human
  • ISCOMATRIX, immunological adjuvant
  • Melanoma