A Double-blind, Randomized, Placebo-controlled Phase III Study to Assess the Efficacy of recMAGE-A3 + AS15 ASCI as Adjuvant Therapy in Patients with MAGE-A3 Positive Resected Stage III Melanoma

IRB-HSR# 14686
Service: Cancer | Category: Cancer (Oncology)
Adult Enrollment: Yes | Minor Enrollment: No
Primary Investigator: Craig L. Slingluff, M.D.

Contact Information

Contact: Beverly Turner
Phone: 434.243.7242
E-mail: bt2h@virginia.edu

Clinical Trial Description

UVA Health System, Human Immune Therapy Center, seeks participants with melanoma for a research study.

The proposed study is a double-blind, randomized, placebo-controlled Phase III study designed to assess the effectiveness of recMAGE-A3 + AS15 ASCI as a therapy in patients with resected MAGE-A3-positive stage III cutaneous melanoma. MAGE-A3 is a melanoma protein that may be expressed in some tumors. Your tumor must have MAGE-A3 in order to be eligible to participate in this study.

The purpose of the present trial is to test whether or not the recMAGE-A3 + AS15 ASCI can prevent or delay recurrence of the tumor in melanoma patients, who have had surgical removal of their tumor. RecMAGE-A3 + AS15 ASCI is an experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in melanoma or in any other cancer.

If you should decide to participate in the study, your tumor sample will be screened for MAGE-A3 expression. Once enrolled in the study, each patient will receive either the investigational drug or an inactive product (called a placebo). The treatment given to the participating patients will be decided by a randomization procedure, which means that the treatment type for each patient is chosen by chance. RecMAGE-A3 + AS15 ASCI and placebo will be administered through intramuscular injections. Participants will undergo as many as 13 cycles (visits) consisting of recMAGE-A3 + AS15 ASCI or placebo injections at each visit, depending upon the randomization. Cycles 1 - 5 are every 3 weeks and cycles 6 - 13 are every 3 months; thus, up to 27 months of treatment. Participants will also be asked to undergo imaging procedures (e.g. CT scans, photographic imaging), physical examinations, possibly biopsies, answer questions regarding their medical history, as well as blood tests and a pregnancy test for women. Treatments take place in the UVA Health System Cancer Center. After treatment, you may have a doctor's visit scheduled every six months for follow-up, for up to 5 years.

Compensation

There is no compensation available for participants in this study.