Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Polynoma LLC
ClinicalTrials.gov Identifier:
NCT01546571
First received: February 26, 2012
Last updated: July 29, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Melanoma
Biological: POL-103A
Biological: POL-103A without API
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Polynoma LLC:

Primary Outcome Measures:
  • Recurrence Free Survival (RFS) [ Time Frame: 362 events ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 472 events ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1059
Study Start Date: April 2012
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  • Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
  • Use of biologic response modifiers within 60 days of first dosing
  • Subjects with history of other malignancy within past 5 years (with exceptions)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546571

  Hide Study Locations
Locations
United States, Arizona
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
Omni Dermatology, Inc.
Phoenix, Arizona, United States, 85018
Alliance Dermatology and MOHS Center, PC
Phoenix, Arizona, United States, 85032
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
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
Duarte, California, United States, 91010
St. Jude Heritage
Fullerton, California, United States, 92835
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
Northern California Melanoma Center/ St. Mary's Medical Center
San Francisco, California, United States, 94117
Advanced Dermatology and Skin Cancer Specialists
Temecula, California, United States, 92592
United States, Colorado
Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
IMMUNOe Research Centers
Centennial, Colorado, United States, 80112
IMMUNOe Research Centers
Longmont, Colorado, United States, 80501
United States, District of Columbia
The Melanoma Center at the Washington Cancer Institute
Washington, District of Columbia, United States, 20010
United States, Florida
Skin Care Research, Inc.
Boca Raton, Florida, United States, 33486
Integrity Clinical Research
Doral, Florida, United States, 33166
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
Lake Research LLC
Miami Lakes, Florida, United States, 33014
MD Anderson Cancer Center-Orlando
Orlando, Florida, United States, 32806
Ameriderm Research
Ormond Beach, Florida, United States, 32174
Olympian Clinical Research
Tampa, Florida, United States, 33609
United States, Illinois
Oncology Specialists, SC (OSSC)
Niles, Illinois, United States, 60714
Southern Illinois School of Medicine
Springfield, Illinois, United States, 62794
United States, Indiana
Investigative Clinical Research of Indiana
Indianapolis, Indiana, United States, 46254
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, Louisiana
Lake Charles, Louisiana, United States, 70605
United States, Maryland
Harry & Jeanette Weinberg Cancer Institute @ Franklin Square
Baltimore, Maryland, United States, 21237
United States, Michigan
Providence Cancer Institute
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
St. Joseph, Missouri, United States, 64506
St. Louis Hospital
St. Louis, Missouri, United States, 63110
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas Skin and Cancer Clinics
Las Vegas, Nevada, United States, 89106
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
E. Carolina University; Brody School of Medicine
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
Fairview Hospital (Cleveland Clinic)
Cleveland, Ohio, United States, 44111
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 Medical 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
Baylor Research Institute
Dallas, Texas, United States, 75204
Cancer Solutions
Dallas, Texas, United States, 75231
Center for Clinical Studies Houston B
Houston, Texas, United States, 77004
Center for Clinical Studies Houston N
Houston, Texas, United States, 77065
Center for Clinical Studies
Webster, Texas, United States, 77598
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
The Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112-5550
United States, Virginia
University of Virginia Hospital
Charlottesville, Virginia, United States, 22908
Inova Melanoma and Skin Cancer Center
Fairfax, Virginia, United States, 22031
Carillion Medical Center
Roanoke, Virginia, United States, 24016
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 Center
Victoria, British Columbia, Canada, V8R6V5
Canada, Ontario
Durham Regional Cancer Center
Oshawa, Ontario, Canada, L1G2B9
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre de Recherche - Hopital Charles-Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A1A1
Canada
CHU de Quebec-L'Hotel-Dieu de Quebec
Quebec, Canada, G1R2J6
Sponsors and Collaborators
Polynoma LLC
Investigators
Principal Investigator: Craig Slingluff, M.D. University of Virginia Hospital
  More Information

Responsible Party: Polynoma LLC
ClinicalTrials.gov Identifier: NCT01546571     History of Changes
Other Study ID Numbers: 103A-301 
Study First Received: February 26, 2012
Last Updated: July 29, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on December 08, 2016