Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients
- Conditions
- Melanoma
- Interventions
- Biological: POL-103A without API
- Registration Number
- NCT01546571
- Lead Sponsor
- Polynoma LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 504
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description POL-103A without API POL-103A without API - POL-103A POL-103A -
- Primary Outcome Measures
Name Time Method Recurrence Free Survival (RFS) 436 events or approximately 4 years This is an event driven trial. Recurrence-free survival time (RFS) is computed from the earliest of the date of recurrence or death or, if without recurrence or death, the date last assessed for recurrence without diagnosis of recurrence (censored). The date of recurrence is specified as the first date a recurrence is suspected, which is later confirmed by biopsy.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 432 events or approximately 10 years Survival time is computed based on the date of death if the subject is known dead or the date last known to be alive (censored). Zero time is the date of randomization.
Trial Locations
- Locations (65)
The Angeles Clinic and Research Institute
🇺🇸Los Angeles, California, United States
Ironwood Cancer and Research Centers
🇺🇸Chandler, Arizona, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Advocate Medical Group
🇺🇸Niles, Illinois, United States
The Melanoma Center at the Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Ameriderm Research
🇺🇸Ormond Beach, Florida, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
UCLA Hematology & Oncology Clinic
🇺🇸Los Angeles, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
Ascension Providence Hospital
🇺🇸Southfield, Michigan, United States
Highlands Oncology Group
🇺🇸Fayetteville, Arkansas, United States
Beverly Hills Cancer Center
🇺🇸Beverly Hills, California, United States
Ventura County Hematology Oncology Specialists
🇺🇸Oxnard, California, United States
St. Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
CISSS de la Montérégie - Centre
🇨🇦Greenfield Park, Quebec, Canada
Cancer Solutions
🇺🇸Dallas, Texas, United States
Inova Schar Cancer Center
🇺🇸Fairfax, Virginia, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Central Kentucky Research Associates
🇺🇸Lexington, Kentucky, United States
Independence Family Health Center (Cleveland Clinic)
🇺🇸Independence, Ohio, United States
Multicare Institute for Research & Innovation
🇺🇸Tacoma, Washington, United States
CHU de Quebec-L'Hotel-Dieu de Quebec
🇨🇦Quebec, Canada
BCCA Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
Thomas Jefferson Medical Oncology
🇺🇸Philadelphia, Pennsylvania, United States
McGlinn Cancer Institute, Reading Hospital
🇺🇸West Reading, Pennsylvania, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Investigative Clinical Research of Indiana
🇺🇸Indianapolis, Indiana, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Harry & Jeanette Weinberg Cancer Institute @ Franklin Square
🇺🇸Baltimore, Maryland, United States
GenesisCare USA of Florida
🇺🇸Jacksonville, Florida, United States
Cancer Specialists of North Florida
🇺🇸Jacksonville, Florida, United States
Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Rutgers Cancer Institute of NJ
🇺🇸New Brunswick, New Jersey, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Premier Health Partners Clinical Trials Research Alliance
🇺🇸Dayton, Ohio, United States
Hillcrest Hospital (Cleveland Clinic)
🇺🇸Mayfield Heights, Ohio, United States
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Princess Margaret Hospital, Department of Medical Oncology
🇨🇦Toronto, Ontario, Canada
Center for Clinical Studies
🇺🇸Houston, Texas, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
The West Clinic P.C. d/b/a West Cancer Center
🇺🇸Germantown, Tennessee, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
John Theurer Cancer Center/ Hackensack Medical Center
🇺🇸Hackensack, New Jersey, United States
University of Virginia Hospital
🇺🇸Charlottesville, Virginia, United States
Durham Regional Cancer Centre
🇨🇦Oshawa, Ontario, Canada
Mayo Clinic Cancer Center, Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
MD Anderson Cancer Center-Orlando
🇺🇸Orlando, Florida, United States
St. Mary's Hospital & Medical Center Department of Pathology
🇺🇸San Francisco, California, United States
Wake Forest University School of Medicine, Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University of Minnesota Masonic Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
The Huntsman Cancer Institute, University of Utah Health Care
🇺🇸Salt Lake City, Utah, United States
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States