MAVIS: Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients
Sponsor
Polynoma LLC (Industry)
Overall Status
Terminated
CT.gov ID
NCT01546571
Collaborator
(none)
504
65
2
110
7.8
0.1
Study Details
Study Description
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 |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
504 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
:
May 1, 2012
Actual Primary Completion Date
:
Apr 29, 2021
Actual Study Completion Date
:
Jun 30, 2021
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Recurrence Free Survival (RFS) [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
- Overall Survival (OS) [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ironwood Cancer and Research Centers | Chandler | Arizona | United States | 85224 |
| 2 | University of Arizona Cancer Center | Tucson | Arizona | United States | 85719 |
| 3 | Highlands Oncology Group | Fayetteville | Arkansas | United States | 72703 |
| 4 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 5 | Beverly Hills Cancer Center | Beverly Hills | California | United States | 90211 |
| 6 | City of Hope National Medical Center | Duarte | California | United States | 91010 |
| 7 | The Angeles Clinic and Research Institute | Los Angeles | California | United States | 90025 |
| 8 | UCLA Hematology & Oncology Clinic | Los Angeles | California | United States | 90095 |
| 9 | Ventura County Hematology Oncology Specialists | Oxnard | California | United States | 93030 |
| 10 | Sutter Cancer Center | Sacramento | California | United States | 95816 |
| 11 | St. Mary's Hospital & Medical Center Department of Pathology | San Francisco | California | United States | 94117 |
| 12 | Anschutz Cancer Pavilion | Aurora | Colorado | United States | 80045 |
| 13 | The Melanoma Center at the Washington Cancer Institute | Washington | District of Columbia | United States | 20010 |
| 14 | GenesisCare USA of Florida | Jacksonville | Florida | United States | 32204 |
| 15 | Cancer Specialists of North Florida | Jacksonville | Florida | United States | 32256 |
| 16 | Mount Sinai Medical Center | Miami Beach | Florida | United States | 33140 |
| 17 | MD Anderson Cancer Center-Orlando | Orlando | Florida | United States | 32806 |
| 18 | Ameriderm Research | Ormond Beach | Florida | United States | 32174 |
| 19 | Advocate Medical Group | Niles | Illinois | United States | 60714 |
| 20 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62794 |
| 21 | Investigative Clinical Research of Indiana | Indianapolis | Indiana | United States | 46260 |
| 22 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 23 | Baptist Health Lexington | Lexington | Kentucky | United States | 40503 |
| 24 | Central Kentucky Research Associates | Lexington | Kentucky | United States | 40509 |
| 25 | University of Louisville | Louisville | Kentucky | United States | 40202 |
| 26 | Harry & Jeanette Weinberg Cancer Institute @ Franklin Square | Baltimore | Maryland | United States | 21237 |
| 27 | Ascension Providence Hospital | Southfield | Michigan | United States | 48075 |
| 28 | University of Minnesota Masonic Cancer Institute | Minneapolis | Minnesota | United States | 55455 |
| 29 | Mayo Clinic Cancer Center, Mayo Clinic Rochester | Rochester | Minnesota | United States | 55905 |
| 30 | Center for Pharmaceutical Research | Kansas City | Missouri | United States | 64114 |
| 31 | MediSearch Clinical Trials | Saint Joseph | Missouri | United States | 64506 |
| 32 | St. Louis University Hospital | Saint Louis | Missouri | United States | 63110 |
| 33 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 34 | Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 35 | John Theurer Cancer Center/ Hackensack Medical Center | Hackensack | New Jersey | United States | 07601 |
| 36 | Rutgers Cancer Institute of NJ | New Brunswick | New Jersey | United States | 08901 |
| 37 | Mount Sinai School of Medicine | New York | New York | United States | 10032 |
| 38 | East Carolina University | Greenville | North Carolina | United States | 27834 |
| 39 | Wake Forest University School of Medicine, Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157 |
| 40 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 41 | Premier Health Partners Clinical Trials Research Alliance | Dayton | Ohio | United States | 45431 |
| 42 | Independence Family Health Center (Cleveland Clinic) | Independence | Ohio | United States | 44131 |
| 43 | Hillcrest Hospital (Cleveland Clinic) | Mayfield Heights | Ohio | United States | 44124 |
| 44 | Bend Memorial Clinic | Bend | Oregon | United States | 97701 |
| 45 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 46 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 47 | Thomas Jefferson Medical Oncology | Philadelphia | Pennsylvania | United States | 19107 |
| 48 | McGlinn Cancer Institute, Reading Hospital | West Reading | Pennsylvania | United States | 19611 |
| 49 | The West Clinic P.C. d/b/a West Cancer Center | Germantown | Tennessee | United States | 38138 |
| 50 | University of Tennessee Medical Center | Knoxville | Tennessee | United States | 37920 |
| 51 | Cancer Solutions | Dallas | Texas | United States | 75231 |
| 52 | Baylor Research Institute | Dallas | Texas | United States | 75246 |
| 53 | Center for Clinical Studies | Houston | Texas | United States | 77004 |
| 54 | Intermountain Medical Center | Murray | Utah | United States | 84107 |
| 55 | The Huntsman Cancer Institute, University of Utah Health Care | Salt Lake City | Utah | United States | 84112-5550 |
| 56 | University of Virginia Hospital | Charlottesville | Virginia | United States | 22908 |
| 57 | Inova Schar Cancer Center | Fairfax | Virginia | United States | 22031 |
| 58 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
| 59 | Multicare Institute for Research & Innovation | Tacoma | Washington | United States | 98405 |
| 60 | BCCA Vancouver Island Cancer Centre | Victoria | British Columbia | Canada | V8R6V5 |
| 61 | Durham Regional Cancer Centre | Oshawa | Ontario | Canada | L1G2B9 |
| 62 | Princess Margaret Hospital, Department of Medical Oncology | Toronto | Ontario | Canada | M5G 2M9 |
| 63 | CISSS de la Montérégie - Centre | Greenfield Park | Quebec | Canada | J4V 2H1 |
| 64 | Royal Victoria Hospital | Montreal | Quebec | Canada | H4A3J1 |
| 65 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Polynoma LLC
ClinicalTrials.gov Identifier:
NCT01546571
Other Study ID Numbers:
- 103A-301
First Posted:
Mar 7, 2012
Last Update Posted:
Dec 8, 2021
Last Verified:
Dec 1, 2021
Additional relevant MeSH terms: