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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01546571
Recruitment Status : Active, not recruiting
First Posted : March 7, 2012
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Melanoma Biological: POL-103A Biological: POL-103A without API Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients With a High Risk of Recurrence
Actual Study Start Date : April 2012
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Placebo Comparator: POL-103A without API Biological: 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

Experimental: POL-103A Biological: 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




Primary Outcome Measures :
  1. Recurrence Free Survival (RFS) [ Time Frame: 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 :
  1. Overall Survival (OS) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546571


Locations
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United States, Arizona
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
City of Hope National Medical Center
Duarte, California, United States, 91010
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
UCLA Hematology & Oncology Clinic
Los Angeles, California, United States, 90095
Ventura County Hematology Oncology Specialists
Oxnard, California, United States, 93030
Sutter Cancer Center
Sacramento, California, United States, 95816
St. Mary's Hospital & Medical Center Department of Pathology
San Francisco, California, United States, 94117
United States, Colorado
Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, District of Columbia
The Melanoma Center at the Washington Cancer Institute
Washington, District of Columbia, United States, 20010
United States, Florida
21st Century Oncology
Jacksonville, Florida, United States, 32204
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
MD Anderson Cancer Center-Orlando
Orlando, Florida, United States, 32806
Ameriderm Research
Ormond Beach, Florida, United States, 32174
United States, Illinois
Advocate Medical Group
Niles, Illinois, United States, 60714
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794
United States, Indiana
Investigative Clinical Research of Indiana
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
Central Kentucky Research Associates
Lexington, Kentucky, United States, 40509
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
Harry & Jeanette Weinberg Cancer Institute @ Franklin Square
Baltimore, Maryland, United States, 21237
United States, Michigan
Ascension Providence Hospital
Southfield, Michigan, United States, 48075
United States, Minnesota
University of Minnesota Masonic Cancer Institute
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center, Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
MediSearch Clinical Trials
Saint Joseph, Missouri, United States, 64506
St. Louis University Hospital
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
John Theurer Cancer Center/ Hackensack Medical Center
Hackensack, New Jersey, United States, 07601
Rutgers Cancer Institute of NJ
New Brunswick, New Jersey, United States, 08901
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10032
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27834
Wake Forest University School of Medicine, Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Premier Health Partners Clinical Trials Research Alliance
Dayton, Ohio, United States, 45431
Independence Family Health Center (Cleveland Clinic)
Independence, Ohio, United States, 44131
Hillcrest Hospital (Cleveland Clinic)
Mayfield Heights, Ohio, United States, 44124
United States, Oregon
Bend Memorial Clinic
Bend, Oregon, United States, 97701
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Thomas Jefferson Medical Oncology
Philadelphia, Pennsylvania, United States, 19107
McGlinn Cancer Institute, Reading Hospital
West Reading, Pennsylvania, United States, 19611
United States, Tennessee
The West Clinic P.C. d/b/a West Cancer Center
Germantown, Tennessee, United States, 38138
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
United States, Texas
Cancer Solutions
Dallas, Texas, United States, 75231
Baylor Research Institute
Dallas, Texas, United States, 75246
Center for Clinical Studies
Houston, Texas, United States, 77004
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
The Huntsman Cancer Institute, University of Utah Health Care
Salt Lake City, Utah, United States, 84112-5550
United States, Virginia
University of Virginia Hospital
Charlottesville, Virginia, United States, 22908
Inova Schar Cancer Center
Fairfax, Virginia, United States, 22031
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Multicare Institute for Research & Innovation
Tacoma, Washington, United States, 98405
Canada, British Columbia
BCCA Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R6V5
Canada, Ontario
Durham Regional Cancer Centre
Oshawa, Ontario, Canada, L1G2B9
Princess Margaret Hospital, Department of Medical Oncology
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CISSS de la Montérégie - Centre
Greenfield Park, Quebec, Canada, J4V 2H1
Royal Victoria Hospital
Montreal, Quebec, Canada, H4A3J1
Canada
CHU de Quebec-L'Hotel-Dieu de Quebec
Quebec, Canada, G1R2J6
Sponsors and Collaborators
Polynoma LLC
Investigators
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Principal Investigator: Craig Slingluff, M.D. University of Virginia Hospital

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Responsible Party: Polynoma LLC
ClinicalTrials.gov Identifier: NCT01546571    
Other Study ID Numbers: 103A-301
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vaccines
Immunologic Factors
Physiological Effects of Drugs