Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: NY-ESO-1 ISCOMATRIX®; ISCOMATRIX® adjuvant
Intervention description: 100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant.
Each patient will receive four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).; 120 μg of ISCOMATRIX® adjuvant
Each patient will receive four intramuscular injections of ISCOMATRIX® adjuvant alone. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase II; Randomized Controlled Trial; Double-Blind; Cancer Vaccine; NY-ESO-1 protein, human; ISCOMATRIX®, immunological adjuvant

Summary:

      The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine
      improves outcomes for people with Malignant Melanoma which has been removed, but is at high
      risk of relapse.
    

Eligibility criteria:

        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 patient 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.