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: September 15, 2013
Last verified: September 2013
  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 75 Years
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
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Arizona Clinical Research
Tucson, Arizona, United States, 85715
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope
Duarte, California, United States, 91010
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Northern California Melanoma Center/ St. Mary's Medical Center
San Francisco, California, United States, 94117
Pacific Dermatology Institute
Temecula, California, United States, 92592
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
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
Oncology Specialists, SC (OSSC)
Niles, Illinois, United States, 60714
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
Central Kentucky Research Associates
Lexington, Kentucky, United States, 40509
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
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
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
St. Louis Hospital
St. 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, New Jersey, United States, 07601
Cancer Center 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
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Wake Forest University School of Medicine, Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson Univ.
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Dallas Surgical Group
Dallas, Texas, United States, 75230
Research Across America
Dallas, Texas, United States, 75234
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
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Polynoma LLC
Investigators
Principal Investigator: Craig Slingluff, M.D. Martha Jefferson Hospital, University of Virginia
  More Information

No publications provided

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: September 15, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014