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

Primary Purpose

Melanoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
POL-103A
POL-103A without API
Sponsored by
Polynoma LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ironwood Cancer and Research Centers
  • University of Arizona Cancer Center
  • Highlands Oncology Group
  • University of Arkansas for Medical Sciences
  • Beverly Hills Cancer Center
  • City of Hope National Medical Center
  • The Angeles Clinic and Research Institute
  • UCLA Hematology & Oncology Clinic
  • Ventura County Hematology Oncology Specialists
  • Sutter Cancer Center
  • St. Mary's Hospital & Medical Center Department of Pathology
  • Anschutz Cancer Pavilion
  • The Melanoma Center at the Washington Cancer Institute
  • GenesisCare USA of Florida
  • Cancer Specialists of North Florida
  • Mount Sinai Medical Center
  • MD Anderson Cancer Center-Orlando
  • Ameriderm Research
  • Advocate Medical Group
  • Southern Illinois University School of Medicine
  • Investigative Clinical Research of Indiana
  • University of Iowa Hospitals and Clinics
  • Baptist Health Lexington
  • Central Kentucky Research Associates
  • University of Louisville
  • Harry & Jeanette Weinberg Cancer Institute @ Franklin Square
  • Ascension Providence Hospital
  • University of Minnesota Masonic Cancer Institute
  • Mayo Clinic Cancer Center, Mayo Clinic Rochester
  • Center for Pharmaceutical Research
  • MediSearch Clinical Trials
  • St. Louis University Hospital
  • Washington University School of Medicine
  • Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center
  • John Theurer Cancer Center/ Hackensack Medical Center
  • Rutgers Cancer Institute of NJ
  • Mount Sinai School of Medicine
  • East Carolina University
  • Wake Forest University School of Medicine, Comprehensive Cancer Center
  • The Cleveland Clinic Foundation
  • Premier Health Partners Clinical Trials Research Alliance
  • Independence Family Health Center (Cleveland Clinic)
  • Hillcrest Hospital (Cleveland Clinic)
  • Bend Memorial Clinic
  • Providence Portland Medical Center
  • Oregon Health and Science University
  • Thomas Jefferson Medical Oncology
  • McGlinn Cancer Institute, Reading Hospital
  • The West Clinic P.C. d/b/a West Cancer Center
  • University of Tennessee Medical Center
  • Cancer Solutions
  • Baylor Research Institute
  • Center for Clinical Studies
  • Intermountain Medical Center
  • The Huntsman Cancer Institute, University of Utah Health Care
  • University of Virginia Hospital
  • Inova Schar Cancer Center
  • Virginia Mason Medical Center
  • Multicare Institute for Research & Innovation
  • BCCA Vancouver Island Cancer Centre
  • Durham Regional Cancer Centre
  • Princess Margaret Hospital, Department of Medical Oncology
  • CISSS de la Montérégie - Centre
  • Royal Victoria Hospital
  • CHU de Quebec-L'Hotel-Dieu de Quebec

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

POL-103A without API

POL-103A

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 26, 2012
Last Updated
December 6, 2021
Sponsor
Polynoma LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01546571
Brief Title
Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients
Acronym
MAVIS
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Planned interim analysis showed a strong signal of efficacy in a pre-specified patient population. Fast track designation was granted and a new, redesigned pivotal trial will be conducted.
Study Start Date
May 1, 2012 (Actual)
Primary Completion Date
April 29, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polynoma LLC

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
504 (Actual)

8. Arms, Groups, and Interventions

Arm Title
POL-103A without API
Arm Type
Placebo Comparator
Arm Title
POL-103A
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
POL-103A
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
POL-103A without API
Intervention Description
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
Primary Outcome Measure Information:
Title
Recurrence Free Survival (RFS)
Description
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.
Time Frame
436 events or approximately 4 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
432 events or approximately 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 Use of biologic response modifiers within 60 days of first dosing Subjects with history of other malignancy within past 5 years (with exceptions)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Slingluff, M.D.
Organizational Affiliation
University of Virginia Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ironwood Cancer and Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
The Angeles Clinic and Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
UCLA Hematology & Oncology Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Ventura County Hematology Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
St. Mary's Hospital & Medical Center Department of Pathology
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
The Melanoma Center at the Washington Cancer Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
GenesisCare USA of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
MD Anderson Cancer Center-Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Advocate Medical Group
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Facility Name
Investigative Clinical Research of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Central Kentucky Research Associates
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Harry & Jeanette Weinberg Cancer Institute @ Franklin Square
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Ascension Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
University of Minnesota Masonic Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center, Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
St. Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
John Theurer Cancer Center/ Hackensack Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Rutgers Cancer Institute of NJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Wake Forest University School of Medicine, Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Premier Health Partners Clinical Trials Research Alliance
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Facility Name
Independence Family Health Center (Cleveland Clinic)
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
Hillcrest Hospital (Cleveland Clinic)
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson Medical Oncology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
McGlinn Cancer Institute, Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
The West Clinic P.C. d/b/a West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Cancer Solutions
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
The Huntsman Cancer Institute, University of Utah Health Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5550
Country
United States
Facility Name
University of Virginia Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Schar Cancer Center
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Multicare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
BCCA Vancouver Island Cancer Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R6V5
Country
Canada
Facility Name
Durham Regional Cancer Centre
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G2B9
Country
Canada
Facility Name
Princess Margaret Hospital, Department of Medical Oncology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CISSS de la Montérégie - Centre
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Facility Name
CHU de Quebec-L'Hotel-Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R2J6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34599031
Citation
Slingluff CL, Lewis KD, Andtbacka R, Hyngstrom J, Milhem M, Markovic SN, Bowles T, Hamid O, Hernandez-Aya L, Claveau J, Jang S, Philips P, Holtan SG, Shaheen MF, Curti B, Schmidt W, Butler MO, Paramo J, Lutzky J, Padmanabhan A, Thomas S, Milton D, Pecora A, Sato T, Hsueh E, Badarinath S, Keech J, Kalmadi S, Kumar P, Weber R, Levine E, Berger A, Bar A, Beck JT, Travers JB, Mihalcioiu C, Gastman B, Beitsch P, Rapisuwon S, Glaspy J, McCarron EC, Gupta V, Behl D, Blumenstein B, Peterkin JJ. Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence. J Immunother Cancer. 2021 Oct;9(10):e003272. doi: 10.1136/jitc-2021-003272.
Results Reference
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Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients

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