Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients
NCT ID: NCT01546571
Last Updated: 2025-10-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
504 participants
INTERVENTIONAL
2012-05-01
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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POL-103A without API
POL-103A without API
Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
POL-103A
POL-103A
POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
Interventions
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POL-103A
POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
POL-103A without API
Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
Eligibility Criteria
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Inclusion Criteria
* Surgical resection within 90 days of first dosing
* Persons with positive sentinel nodes must have a complete lymphadenectomy
* ECOG performance status 0 or 1
Exclusion Criteria
* Use of biologic response modifiers within 60 days of first dosing
* Subjects with history of other malignancy within past 5 years (with exceptions)
18 Years
80 Years
ALL
No
Sponsors
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Polynoma LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Craig Slingluff, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Hospital
Locations
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Ironwood Cancer and Research Centers
Chandler, Arizona, United States
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
Harry & Jeanette Weinberg Cancer Institute @ Franklin Square
Baltimore, Maryland, United States
Ascension Providence Hospital
Southfield, Michigan, United States
University of Minnesota Masonic Cancer Institute
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Mayo Clinic Rochester
Rochester, Minnesota, United States
Center for Pharmaceutical Research
Kansas City, Missouri, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
St. Louis University Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
John Theurer Cancer Center/ Hackensack Medical Center
Hackensack, New Jersey, United States
Rutgers Cancer Institute of NJ
New Brunswick, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
East Carolina University
Greenville, North Carolina, United States
Wake Forest University School of Medicine, Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Premier Health Partners Clinical Trials Research Alliance
Dayton, Ohio, United States
Independence Family Health Center (Cleveland Clinic)
Independence, Ohio, United States
Hillcrest Hospital (Cleveland Clinic)
Mayfield Heights, Ohio, United States
Bend Memorial Clinic
Bend, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Thomas Jefferson Medical Oncology
Philadelphia, Pennsylvania, United States
McGlinn Cancer Institute, Reading Hospital
West Reading, Pennsylvania, United States
The West Clinic P.C. d/b/a West Cancer Center
Germantown, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Cancer Solutions
Dallas, Texas, United States
Baylor Research Institute
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
The Huntsman Cancer Institute, University of Utah Health Care
Salt Lake City, Utah, United States
University of Virginia Hospital
Charlottesville, Virginia, United States
Inova Schar Cancer Center
Fairfax, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Multicare Institute for Research & Innovation
Tacoma, Washington, United States
BCCA Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
Durham Regional Cancer Centre
Oshawa, Ontario, Canada
Princess Margaret Hospital, Department of Medical Oncology
Toronto, Ontario, Canada
CISSS de la Montérégie - Centre
Greenfield Park, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
CHU de Quebec-L'Hotel-Dieu de Quebec
Québec, , Canada
Countries
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References
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Slingluff CL, Lewis KD, Andtbacka R, Hyngstrom J, Milhem M, Markovic SN, Bowles T, Hamid O, Hernandez-Aya L, Claveau J, Jang S, Philips P, Holtan SG, Shaheen MF, Curti B, Schmidt W, Butler MO, Paramo J, Lutzky J, Padmanabhan A, Thomas S, Milton D, Pecora A, Sato T, Hsueh E, Badarinath S, Keech J, Kalmadi S, Kumar P, Weber R, Levine E, Berger A, Bar A, Beck JT, Travers JB, Mihalcioiu C, Gastman B, Beitsch P, Rapisuwon S, Glaspy J, McCarron EC, Gupta V, Behl D, Blumenstein B, Peterkin JJ. Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence. J Immunother Cancer. 2021 Oct;9(10):e003272. doi: 10.1136/jitc-2021-003272.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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103A-301
Identifier Type: -
Identifier Source: org_study_id
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