Phase II Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma

Inclusion Criteria

Inclusion Criteria :

- A pathologically confirmed diagnosis of malignant melanoma with at least one
measurable metastatic lesion with a minimum lesion size of 20 mm, based on
radiological assessment (or 10 mm if assessed by spiral computed tomography [CT] scan
) as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Stages IIIc,
IVa, or IVb only, according to the American Joint Committee on Cancer (AJCC) staging
system for melanoma). Cutaneous metastasis (assessed by physical examination) must be
at least 10 mm. CT scan or magnetic resonance imaging (MRI) is required to rule out
brain metastases.

- Patients who received prior treatment for their metastatic disease must have
objective evidence of disease progression.

- Aged ≥ 18 years on the day of inclusion

- IRB-approved informed consent form signed

- Able to attend all scheduled visits and to comply with all trial procedures

- For a woman, inability to bear a child or negative serum pregnancy test

- For a woman of child-bearing potential, using an effective method of contraception or
abstinence during the study and at least 4 weeks after the last study treatment

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life
expectancy of at least 6 months.

- Adequate hematologic, hepatic, and renal function (at pre-defined laboratory
values).

- Fully recovered from surgery, if applicable.

Exclusion Criteria :

- Receipt of two or more previous therapies for metastatic melanoma.

- Receipt of chemotherapy or another therapy for metastatic melanoma within the last
four weeks

- Receipt of adjuvant interferon therapy within the last six months

- Concurrent receipt of radiotherapy for the metastatic disease, unless for palliative
purposes

- Participation in another clinical trial within the four weeks preceding the first
trial treatment

- Planned participation in another clinical trial during the present trial period

- Known Human Immunodeficiency Virus (HIV) infection or hepatitis B (Ag HBs) or
hepatitis C seropositivity

- Presence of active autoimmune disease (excluding vitiligo)

- Systemic hypersensitivity to bovine products or to any of the vaccine components,
including egg products or Neomycin (used to prepare the vaccine), or history of a
life-threatening reaction to granulocyte-macrophage colony stimulating factor
(GM-CSF) or interferon (IFN)-α2b

- Current alcohol or drug addiction that may interfere with the ability to comply with
trial procedures

- Significant co-morbid medical conditions, including pre-existing renal disease,
cirrhosis, or major depression, which in the estimation of the investigator would
preclude safe participation in the study or the accurate interpretation of data.

- A calculated glomerular filtration rate (GFR) <60 mL/min (based on the Cockroft-Gault
formula).

- Previous receipt of a modified canarypox virus (ALVAC)-based vaccine.