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

NCT01546571 | Terminated Phase 3 Results DMC

• 1 other identifier: 103A-301
• Study Type: interventional
• Target: 504
• Locations: 2 countries
• Sites: 65

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (1)

• Part B1: Overall Survival (OS)

  Overall survival (OS) was measured from randomization until death from any cause, assessed up to 76 months.

Study Arms (2)

POL-103A without API

PLACEBO COMPARATOR

Biological: POL-103A without API

POL-103A

EXPERIMENTAL

Biological: POL-103A

Interventions

POL-103A BIOLOGICAL

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

POL-103A

POL-103A without API BIOLOGICAL

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

POL-103A without API

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Polynoma LLC: lead

Study Sites (65)

Ironwood Cancer and Research Centers

Chandler, Arizona, 85224, United States

Location

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

UCLA Hematology & Oncology Clinic

Los Angeles, California, 90095, United States

Location

Ventura County Hematology Oncology Specialists

Oxnard, California, 93030, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

St. Mary's Hospital & Medical Center Department of Pathology

San Francisco, California, 94117, United States

Location

Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

The Melanoma Center at the Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

GenesisCare USA of Florida

Jacksonville, Florida, 32204, United States

Location

Cancer Specialists of North Florida

Jacksonville, Florida, 32256, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MD Anderson Cancer Center-Orlando

Orlando, Florida, 32806, United States

Location

Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Advocate Medical Group

Niles, Illinois, 60714, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

Location

Investigative Clinical Research of Indiana

Indianapolis, Indiana, 46260, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Harry & Jeanette Weinberg Cancer Institute @ Franklin Square

Baltimore, Maryland, 21237, United States

Location

Ascension Providence Hospital

Southfield, Michigan, 48075, United States

Location

University of Minnesota Masonic Cancer Institute

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center, Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

John Theurer Cancer Center/ Hackensack Medical Center

Hackensack, New Jersey, 07601, United States

Location

Rutgers Cancer Institute of NJ

New Brunswick, New Jersey, 08901, United States

Location

Mount Sinai School of Medicine

New York, New York, 10032, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Wake Forest University School of Medicine, Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Premier Health Partners Clinical Trials Research Alliance

Dayton, Ohio, 45431, United States

Location

Independence Family Health Center (Cleveland Clinic)

Independence, Ohio, 44131, United States

Location

Hillcrest Hospital (Cleveland Clinic)

Mayfield Heights, Ohio, 44124, United States

Location

Bend Memorial Clinic

Bend, Oregon, 97701, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson Medical Oncology

Philadelphia, Pennsylvania, 19107, United States

Location

McGlinn Cancer Institute, Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

The West Clinic P.C. d/b/a West Cancer Center

Germantown, Tennessee, 38138, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Cancer Solutions

Dallas, Texas, 75231, United States

Location

Baylor Research Institute

Dallas, Texas, 75246, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

The Huntsman Cancer Institute, University of Utah Health Care

Salt Lake City, Utah, 84112-5550, United States

Location

University of Virginia Hospital

Charlottesville, Virginia, 22908, United States

Location

Inova Schar Cancer Center

Fairfax, Virginia, 22031, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Multicare Institute for Research & Innovation

Tacoma, Washington, 98405, United States

Location

BCCA Vancouver Island Cancer Centre

Victoria, British Columbia, V8R6V5, Canada

Location

Durham Regional Cancer Centre

Oshawa, Ontario, L1G2B9, Canada

Location

Princess Margaret Hospital, Department of Medical Oncology

Toronto, Ontario, M5G 2M9, Canada

Location

CISSS de la Montérégie - Centre

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H4A3J1, Canada

Location

CHU de Quebec-L'Hotel-Dieu de Quebec

Québec, G1R2J6, Canada

Location

Related Publications (1)

• 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.

  PMID: 34599031 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Program Director
• Organization: Polynoma

karihatten@polynoma.com

5418405451

Study Officials

• Craig Slingluff, M.D.

  University of Virginia Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2012
• First Posted: March 7, 2012
• Study Start: May 1, 2012
• Primary Completion: April 29, 2021
• Study Completion: June 30, 2021
• Last Updated: October 24, 2025
• Results First Posted: October 24, 2025

Record last verified: 2025-09

Locations

US (59); CA (6)