Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients (MAVIS)
This study is currently recruiting participants.
Verified February 2013 by Polynoma LLC
Sponsor:
Polynoma LLC
Information provided by (Responsible Party):
Polynoma LLC
ClinicalTrials.gov Identifier:
NCT01546571
First received: February 26, 2012
Last updated: February 13, 2013
Last verified: February 2013
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546571
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Contacts
| Contact: Deb Jezior | (858) 254-8480 | debjezior@polynoma.com |
| Contact: Patrick Mallon | (858) 205-2501 | pmallon@polynoma.com |
Hide Study LocationsLocations
| 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 | |
| Arizona Clinical Research | Recruiting |
| Tucson, Arizona, United States, 85715 | |
| Contact: Patricia Plezia, Ph.D. 520-290-2510 | |
| Principal Investigator: Manuel Modiano, MD | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Cindy Witkowski 501-526-6990 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 | |
| Pacific Dermatology Institute | Recruiting |
| Temecula, California, United States, 92592 | |
| Contact: Ashley Brook 951-303-6900 | |
| Principal Investigator: Jesse Mitchell, MD | |
| United States, Colorado | |
| Anschutz Cancer Pavilion | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Barb Criminelli 720-848-0652 | |
| 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: Sekwon Jang, MD | |
| United States, Florida | |
| Mount Sinai Medical Center | Recruiting |
| Miami Beach, Florida, United States, 33140 | |
| Contact: Yvonne Enriquez-Nunez 305-674-2625 | |
| Principal Investigator: Jose Lutzky, MD | |
| MD Anderson Cancer Center-Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Jean Edwards 321-841-6653 | |
| Principal Investigator: Gregory Pennock, MD | |
| Ameriderm Research | Recruiting |
| Ormond Beach, Florida, United States, 32174 | |
| Contact: Jody Wheeler 386-898-0547 | |
| Principal Investigator: James Solomon, MD | |
| United States, Illinois | |
| Oncology Specialists, SC (OSSC) | Recruiting |
| Niles, Illinois, United States, 60714 | |
| Contact: Sara Edwards 847-410-0658 | |
| 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 319-353-7251 | |
| Principal Investigator: Mohammed Milhem, MD | |
| United States, Kentucky | |
| Central Kentucky Research Associates | Recruiting |
| Lexington, Kentucky, United States, 40509 | |
| Contact: Susan Lanthorn 859-977-7144 | |
| Principal Investigator: James Borders, MD | |
| Central Baptist Hospital | Recruiting |
| Lexington, Kentucky, United States, 40503 | |
| Contact: Heather Tudor 859-260-3196 | |
| Principal Investigator: Peter Tate, MD | |
| United States, Minnesota | |
| University of Minnesota Masonic Cancer Institute | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Kathy Evans 612-626-3369 | |
| Principal Investigator: Venkatesh Rudrapatna, MD | |
| Mayo Clinic Cancer Center, Mayo Clinic Rochester | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Jane Milburn 507-266-0743 | |
| Principal Investigator: Svetomir Markovic, MD, PhD | |
| United States, Missouri | |
| Center for Pharmaceutical Research | Recruiting |
| Kansas City, Missouri, United States, 64114 | |
| Contact: Missy MacPhail 816-943-0770 | |
| Principal Investigator: John Ervin, MD | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Chloe Fournier 314-747-4235 | |
| Principal Investigator: Gerald Linette, MD | |
| St. Louis Hospital | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Kathryn Lindsay 314-577-8460 | |
| Principal Investigator: Eddy Hsueh | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756 | |
| Contact: Eryn Bagley 603-650-4035 | |
| Principal Investigator: Marc Ernstoff, MD | |
| 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: Lori Pruski-Clark 732-235-9835 | |
| Principal Investigator: Janice Mehnert, MD | |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Debbie Lehrer 212-824-7376 | |
| Principal Investigator: Yvonne Saenger, MD | |
| United States, North Carolina | |
| Wake Research Associates | Recruiting |
| Raleigh, North Carolina, United States, 27612 | |
| Contact: Tansy Olio 919-781-2514 | |
| Principal Investigator: Adrian Nasir, MD | |
| 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, Pennsylvania | |
| Kimmel Cancer Center at Thomas Jefferson Univ. | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Mary Ann Laudadio 215-955-9980 | |
| Principal Investigator: Kendra Feeney, MD | |
| United States, Texas | |
| Research Across America | Recruiting |
| Dallas, Texas, United States, 75234 | |
| Contact: Enrique Echaniz | |
| Contact 972 492 6990 ext 135 | |
| Principal Investigator: Jeffrey Adelglass, MD | |
| Dallas Surgical Group | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact: Tiffany Huber 972-566-4143 | |
| Principal Investigator: Peter Beitsch, MD | |
| United States, Utah | |
| Intermountain Medical Center | Recruiting |
| Murray, Utah, United States, 84107 | |
| Contact: Tricia Fullmer 801-408-3887 | |
| Principal Investigator: Tawnya Bowles, MD | |
| The Huntsman Cancer Institute, University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84112-5550 | |
| Contact: Jennifer Demko 801-587-4342 | |
| Principal Investigator: Robert Andtbacka, MD | |
| United States, Virginia | |
| University of Virginia Hospital | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Sasha White 434-982-1902 | |
| Principal Investigator: Craig Slingluff, MD | |
| Clinical Research Associates of Tidewater | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Edith Wombolt 757-627-7446 | |
| Principal Investigator: Duane Wombolt, 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 13, 2013 |
| 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 May 23, 2013