Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Melanoma

In brief

The purpose of this study is to determine how safe and how well POL-103A works in preventing the relapse of melanoma after patients who have undergone surgery.

Key facts

Study ID

NCT01546571

Run by

Polynoma LLC

People needed

504

Starts

2012-05-01

Expected to finish

2021-06-30

Last updated by the study team

2025-10-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed Stage IIb, IIc, III melanoma
• Surgical resection within 90 days of first dosing
• Persons with positive sentinel nodes must have a complete lymphadenectomy
• ECOG performance status 0 or 1

You may not qualify if…

• Any prior melanoma treatment other than surgery or regional irradiation
• Use of biologic response modifiers within 60 days of first dosing
• Subjects with history of other malignancy within past 5 years (with exceptions)

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Beverly Hills Cancer Center — Beverly Hills, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• UCLA Hematology & Oncology Clinic — Los Angeles, California, United States
• Ventura County Hematology Oncology Specialists — Oxnard, California, United States
• Sutter Cancer Center — Sacramento, California, United States
• St. Mary's Hospital & Medical Center Department of Pathology — San Francisco, California, United States
• Anschutz Cancer Pavilion — Aurora, Colorado, United States
• The Melanoma Center at the Washington Cancer Institute — Washington D.C., District of Columbia, United States
• GenesisCare USA of Florida — Jacksonville, Florida, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• MD Anderson Cancer Center-Orlando — Orlando, Florida, United States
• Ameriderm Research — Ormond Beach, Florida, United States
• Advocate Medical Group — Niles, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Investigative Clinical Research of Indiana — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Central Kentucky Research Associates — Lexington, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• Ironwood Cancer and Research Centers — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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