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

Phase 2
18 Years
Not Enrolling
Melanoma, Cancer

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Trial Information

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

Eligible participants will be randomized to receive either a vaccine treatment consisting of
a series of multi-antigen melanoma vaccine and GM-CSF injections, followed by high-dose
IFN-α2b or only the high-dose IFN-α2b.

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

- 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

- 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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Summary of Disease Progression in Study Participants, Intent-to-treat Population

Outcome Description:

Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography [CT] scans or physical examination).

Outcome Time Frame:

Day 0 up to 35 weeks post 1st vaccination or treatment

Safety Issue:


Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi Pasteur Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

June 2010

Related Keywords:

  • Melanoma
  • Cancer
  • Melanoma, Cancer
  • Melanoma



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