Melanoma Clinical Trial
— MAVISOfficial 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
| NCT number | NCT01546571 |
| Other study ID # | 103A-301 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | May 1, 2012 |
| Est. completion date | June 30, 2021 |
| Verified date | December 2021 |
| Source | Polynoma LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 504 |
| Est. completion date | June 30, 2021 |
| Est. primary completion date | April 29, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | CISSS de la Montérégie - Centre | Greenfield Park | Quebec |
| Canada | Royal Victoria Hospital | Montreal | Quebec |
| Canada | Durham Regional Cancer Centre | Oshawa | Ontario |
| Canada | CHU de Quebec-L'Hotel-Dieu de Quebec | Quebec | |
| Canada | Princess Margaret Hospital, Department of Medical Oncology | Toronto | Ontario |
| Canada | BCCA Vancouver Island Cancer Centre | Victoria | British Columbia |
| United States | Anschutz Cancer Pavilion | Aurora | Colorado |
| United States | Harry & Jeanette Weinberg Cancer Institute @ Franklin Square | Baltimore | Maryland |
| United States | Bend Memorial Clinic | Bend | Oregon |
| United States | Beverly Hills Cancer Center | Beverly Hills | California |
| United States | Ironwood Cancer and Research Centers | Chandler | Arizona |
| United States | University of Virginia Hospital | Charlottesville | Virginia |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Baylor Research Institute | Dallas | Texas |
| United States | Cancer Solutions | Dallas | Texas |
| United States | Premier Health Partners Clinical Trials Research Alliance | Dayton | Ohio |
| United States | City of Hope National Medical Center | Duarte | California |
| United States | Inova Schar Cancer Center | Fairfax | Virginia |
| United States | Highlands Oncology Group | Fayetteville | Arkansas |
| United States | The West Clinic P.C. d/b/a West Cancer Center | Germantown | Tennessee |
| United States | East Carolina University | Greenville | North Carolina |
| United States | John Theurer Cancer Center/ Hackensack Medical Center | Hackensack | New Jersey |
| United States | Center for Clinical Studies | Houston | Texas |
| United States | Independence Family Health Center (Cleveland Clinic) | Independence | Ohio |
| United States | Investigative Clinical Research of Indiana | Indianapolis | Indiana |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| United States | Cancer Specialists of North Florida | Jacksonville | Florida |
| United States | GenesisCare USA of Florida | Jacksonville | Florida |
| United States | Center for Pharmaceutical Research | Kansas City | Missouri |
| United States | University of Tennessee Medical Center | Knoxville | Tennessee |
| United States | Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | Baptist Health Lexington | Lexington | Kentucky |
| United States | Central Kentucky Research Associates | Lexington | Kentucky |
| United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
| United States | The Angeles Clinic and Research Institute | Los Angeles | California |
| United States | UCLA Hematology & Oncology Clinic | Los Angeles | California |
| United States | University of Louisville | Louisville | Kentucky |
| United States | Hillcrest Hospital (Cleveland Clinic) | Mayfield Heights | Ohio |
| United States | Mount Sinai Medical Center | Miami Beach | Florida |
| United States | University of Minnesota Masonic Cancer Institute | Minneapolis | Minnesota |
| United States | Intermountain Medical Center | Murray | Utah |
| United States | Rutgers Cancer Institute of NJ | New Brunswick | New Jersey |
| United States | Mount Sinai School of Medicine | New York | New York |
| United States | Advocate Medical Group | Niles | Illinois |
| United States | MD Anderson Cancer Center-Orlando | Orlando | Florida |
| United States | Ameriderm Research | Ormond Beach | Florida |
| United States | Ventura County Hematology Oncology Specialists | Oxnard | California |
| United States | Thomas Jefferson Medical Oncology | Philadelphia | Pennsylvania |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Providence Portland Medical Center | Portland | Oregon |
| United States | Mayo Clinic Cancer Center, Mayo Clinic Rochester | Rochester | Minnesota |
| United States | Sutter Cancer Center | Sacramento | California |
| United States | MediSearch Clinical Trials | Saint Joseph | Missouri |
| United States | St. Louis University Hospital | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | The Huntsman Cancer Institute, University of Utah Health Care | Salt Lake City | Utah |
| United States | St. Mary's Hospital & Medical Center Department of Pathology | San Francisco | California |
| United States | Virginia Mason Medical Center | Seattle | Washington |
| United States | Ascension Providence Hospital | Southfield | Michigan |
| United States | Southern Illinois University School of Medicine | Springfield | Illinois |
| United States | Multicare Institute for Research & Innovation | Tacoma | Washington |
| United States | University of Arizona Cancer Center | Tucson | Arizona |
| United States | The Melanoma Center at the Washington Cancer Institute | Washington | District of Columbia |
| United States | McGlinn Cancer Institute, Reading Hospital | West Reading | Pennsylvania |
| United States | Wake Forest University School of Medicine, Comprehensive Cancer Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Polynoma LLC |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recurrence Free Survival (RFS) | 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. | 436 events or approximately 4 years | |
| Secondary | Overall Survival (OS) | 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. | 432 events or approximately 10 years |
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