Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Polynoma LLC
Sponsor:
Information provided by (Responsible Party):
Polynoma LLC
ClinicalTrials.gov Identifier:
NCT01546571
First received: February 26, 2012
Last updated: February 26, 2015
Last verified: February 2015
  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
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

Contacts
Contact: Deb Jezior (858) 254-8480 debjezior@polynoma.com

  Hide Study Locations
Locations
United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85719
Contact: Susan Jordan, BS.,CCRC    520-694-9056      
Principal Investigator: Lee Cranmer, MD         
United States, Arkansas
Burke Pharmaceutical Research Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Laura Manley    501-620-4449      
Principal Investigator: Dowling Stough, MD         
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Shana Fetters    501-686-8274 ext 8026      
Principal Investigator: Laura Hutchins, MD         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Raechelle Tinsley    626-256-4673 ext 63015      
Principal Investigator: Sanjay Awasthi, MD         
The Angeles Clinic and Research Institute Recruiting
Los Angeles, California, United States, 90025
Contact: Saba Mukarram    310-582-7900      
Principal Investigator: Omid Hamid, MD         
Northern California Melanoma Center/ St. Mary's Medical Center Recruiting
San Francisco, California, United States, 94117
Contact: Lonnie Leonard    415-750-4060      
Principal Investigator: Lynn Spitler, MD         
Advanced Dermatology and Skin Cancer Specialists Recruiting
Temecula, California, United States, 92592
Contact: Tara Krishka    951-303-6900      
Principal Investigator: Jesse Mitchell, MD         
United States, Colorado
Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Lisa Lopez    720-848-0746      
Principal Investigator: Karl Lewis, MD         
United States, District of Columbia
The Melanoma Center at the Washington Cancer Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact: Chris Mathew    202-877-5371      
Principal Investigator: Dennis Priebat, MD         
United States, Florida
Skin Care Research, Inc. Not yet recruiting
Boca Raton, Florida, United States, 33486
Contact: Angie Garcia    561-750-0544      
Principal Investigator: Marta Rendon, MD         
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Dawn Poller    305-674-2121      
Principal Investigator: Jose Lutzky, MD         
MD Anderson Cancer Center-Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Jean Edwards    321-841-7303      
Principal Investigator: Sajeve Thomas, MD         
Ameriderm Research Recruiting
Ormond Beach, Florida, United States, 32174
Contact: Sandra Warrington-Davis    386-898-0547      
Principal Investigator: James Solomon, MD         
United States, Illinois
Oncology Specialists, SC (OSSC) Recruiting
Niles, Illinois, United States, 60714
Contact: Dilnaz Hassan    847-410-0667      
Principal Investigator: Sigrun Hallmeyer, MD         
United States, Indiana
Investigative Clinical Research of Indiana Recruiting
Indianapolis, Indiana, United States, 46254
Contact: Leslie Weitman    317-297-2208      
Principal Investigator: Stephen Schultz, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Melanie Frees    319-356-1228      
Principal Investigator: Mohammed Milhem, MD         
United States, Kentucky
Central Baptist Hospital Recruiting
Lexington, Kentucky, United States, 40503
Contact: Heather Tudor    859-260-3196      
Principal Investigator: Peter Tate, MD         
Central Kentucky Research Associates Active, not recruiting
Lexington, Kentucky, United States, 40509
United States, Louisiana
Recruiting
Lake Charles, Louisiana, United States, 70605
Contact: Cindi Reed, PharmD    337-477-0011      
Principal Investigator: Shondra Smith, MD         
United States, Minnesota
University of Minnesota Masonic Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Anne Janisch    612-626-5369      
Principal Investigator: Venkatesh Rudrapatna, MD         
Mayo Clinic Cancer Center, Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Renee Bradshaw    507-284-2041      
Principal Investigator: Svetomir Markovic, MD, PhD         
United States, Missouri
Center for Pharmaceutical Research Recruiting
Kansas City, Missouri, United States, 64114
Contact: Tish Mauk    816-943-0770      
Principal Investigator: John Ervin, MD         
MediSearch Clinical Trials Recruiting
St. Joseph, Missouri, United States, 64506
Contact: Christy Hughes    816-364-1507      
Principal Investigator: Melody Stone, MD         
St. Louis Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Kathryn Lindsay    314-577-8460      
Principal Investigator: Eddy Hsueh         
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Amer Alyasira    314-747-7992      
Principal Investigator: Gerald Linette, MD         
United States, Nevada
Las Vegas Skin and Cancer Clinics Not yet recruiting
Las Vegas, Nevada, United States, 89106
Contact: Marcie Popovich    702-258-1001 ext 108      
Principal Investigator: Lucius Blanchard, MD         
United States, New Hampshire
Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Danielle Blair, RN, BSN, OCN    201-996-5809      
Principal Investigator: Andrew Pecora, MD         
Cancer Center of NJ Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Megan Burt    732-235-8528      
Principal Investigator: Janice Mehnert, MD         
United States, New York
Mount Sinai School of Medicine Active, not recruiting
New York, New York, United States, 10032
United States, North Carolina
Wake Forest University School of Medicine, Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Joyce Fenstermaker, RN    336-713-3155      
Principal Investigator: Edward Levine, MD         
United States, Oregon
Bend Medical Clinic Recruiting
Bend, Oregon, United States, 97701
Contact: Christine Reed    541-706-6592      
Principal Investigator: William Schmidt, MD         
United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson Univ. Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Katherine Sohon    215-503-7484      
Principal Investigator: Kendra Feeney, MD         
United States, Texas
Dallas Surgical Group Recruiting
Dallas, Texas, United States, 75230
Contact: Tiffany Huber    972-566-4143      
Principal Investigator: Peter Beitsch, MD         
Center for Clinical Studies Recruiting
Houston, Texas, United States, 77004
Contact: Christopher Downing, MD    713-528-8818      
Principal Investigator: Keith Tyring, MD         
Center for Clinical Studies Recruiting
Houston, Texas, United States, 77065
Contact: Sivaramya Kollipara, MD    713-554-4688      
Principal Investigator: Lauren Campbell, MD         
Center for Clinical Studies Recruiting
Webster, Texas, United States, 77598
Contact: Michael Lee, MD    281-333-2288      
Principal Investigator: Patricia Lee, MD         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Tricia Fullmer    801-507-3951      
Principal Investigator: Tawnya Bowles, MD         
The Huntsman Cancer Institute, University of Utah Recruiting
Salt Lake City, Utah, United States, 84112-5550
Contact: Andrew Grandemange    801-213-4323      
Principal Investigator: Robert Andtbacka, MD         
United States, Virginia
University of Virginia Hospital Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kristy Scott    434-982-6714      
Principal Investigator: Craig Slingluff, MD         
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: February 26, 2015
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 March 03, 2015