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

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

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.

Study Overview

• Status: Terminated
• Conditions: Melanoma
• Intervention / Treatment: Biological: POL-103A without API; Biological: POL-103A

• Study Type: Interventional
• Enrollment (Actual): 504
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1R2J6
    • CHU de Quebec-L'Hotel-Dieu de Quebec
  • British Columbia
    • Victoria, British Columbia, Canada, V8R6V5
      • BCCA Vancouver Island Cancer Centre
  • Ontario
    • Oshawa, Ontario, Canada, L1G2B9
      • Durham Regional Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital, Department of Medical Oncology
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • CISSS de la Montérégie - Centre
    • Montreal, Quebec, Canada, H4A3J1
      • Royal Victoria Hospital
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Ironwood Cancer and Research Centers
    • Tucson, Arizona, United States, 85719
      • University of Arizona Cancer Center
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Beverly Hills, California, United States, 90211
      • Beverly Hills Cancer Center
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • Los Angeles, California, United States, 90025
      • The Angeles Clinic and Research Institute
    • Los Angeles, California, United States, 90095
      • UCLA Hematology & Oncology Clinic
    • Oxnard, California, United States, 93030
      • Ventura County Hematology Oncology Specialists
    • Sacramento, California, United States, 95816
      • Sutter Cancer center
    • San Francisco, California, United States, 94117
      • St. Mary's Hospital & Medical Center Department of Pathology
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Anschutz Cancer Pavilion
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • The Melanoma Center at the Washington Cancer Institute
  • Florida
    • Jacksonville, Florida, United States, 32204
      • GenesisCare USA of Florida
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Orlando, Florida, United States, 32806
      • MD Anderson Cancer Center-Orlando
    • Ormond Beach, Florida, United States, 32174
      • Ameriderm Research
  • Illinois
    • Niles, Illinois, United States, 60714
      • Advocate Medical Group
    • Springfield, Illinois, United States, 62794
      • Southern Illinois University School of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Investigative Clinical Research of Indiana
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Harry & Jeanette Weinberg Cancer Institute @ Franklin Square
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Ascension Providence Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Masonic Cancer Institute
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center, Mayo Clinic Rochester
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Center For Pharmaceutical Research
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • St Louis, Missouri, United States, 63110
      • St. Louis University Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center/ Hackensack Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of NJ
  • New York
    • New York, New York, United States, 10032
      • Mount Sinai School of Medicine
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine, Comprehensive Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Dayton, Ohio, United States, 45431
      • Premier Health Partners Clinical Trials Research Alliance
    • Independence, Ohio, United States, 44131
      • Independence Family Health Center (Cleveland Clinic)
    • Mayfield Heights, Ohio, United States, 44124
      • Hillcrest Hospital (Cleveland Clinic)
  • Oregon
    • Bend, Oregon, United States, 97701
      • Bend Memorial Clinic
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Medical Oncology
    • West Reading, Pennsylvania, United States, 19611
      • McGlinn Cancer Institute, Reading Hospital
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic P.C. d/b/a West Cancer Center
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
  • Texas
    • Dallas, Texas, United States, 75231
      • Cancer Solutions
    • Dallas, Texas, United States, 75246
      • Baylor Research Institute
    • Houston, Texas, United States, 77004
      • Center For Clinical Studies
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Salt Lake City, Utah, United States, 84112-5550
      • The Huntsman Cancer Institute, University of Utah Health Care
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University Of Virginia Hospital
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Center
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research & Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part B1: 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.	432 events or 8 years and 10 months
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight MW) Range 1 [0,20)	For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: > 0% (meaning any change), or > 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.	Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for WM range 1.
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 2 [20,28)	For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: > 0% (meaning any change), or > 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.	Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 2
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 3 [28,36)	For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: > 0% (meaning any change), or > 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.	Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 3
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 4 [36,44)	For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: > 0% (meaning any change), or > 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.	Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 4
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 5 [44,53)	For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: > 0% (meaning any change), or > 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.	Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 5
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 6 [53,62)	For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: > 0% (meaning any change), or > 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.	Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 6
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 7 [62,72)	For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: > 0% (meaning any change), or > 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.	Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 7
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 8 [72,83)	For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: > 0% (meaning any change), or > 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.	Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 8
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 9 [83,94)	For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: > 0% (meaning any change), or > 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.	Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 9
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 10 [94,105)	For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: > 0% (meaning any change), or > 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.	Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 10
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 11 [105,118)	For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: > 0% (meaning any change), or > 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.	Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 11
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 12 [118,Inf)	For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: > 0% (meaning any change), or > 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.	Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part B1: Overall Survival (OS)	Overall survival (OS) analyses were based on the ITT analysis set; OS was defined as the duration from randomization until death. If the patient was alive, OS was censored at the earliest date the participant was known to be alive or the date of data cutoff.	Overall survival (OS) was measured from randomization until death from any cause, assessed up to 76 months.

Collaborators and Investigators

• Sponsor: Polynoma LLC
• Investigators: Principal Investigator: Craig Slingluff, M.D., University Of Virginia Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): April 29, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: February 26, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimated): March 7, 2012

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma
• Other Study ID Numbers: 103A-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No