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Melanoma vaccine trial halted: hope for recurrence prevention unclear

NCT ID NCT01546571

Prevention Sponsor: Polynoma LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested a vaccine called POL-103A (Seviprotimut-L) in 504 people with high-risk melanoma who had just had surgery. The goal was to see if the vaccine could prevent the cancer from coming back. However, the study was terminated early, so it is not known whether the vaccine is safe or effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
POL-103A (Seviprotimut-L) melanoma vaccine
What this could lead to
If it had worked, this vaccine could have helped prevent melanoma from coming back after surgery, potentially reducing the need for further treatments.
What could go wrong
The trial was terminated early, so we don't know if the vaccine is effective. Early-stage results may not hold up, and the vaccine might not work for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

504 people

The number who actually took part.

Started

May 2012

Finished

Jun 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

Contacts and locations

Locations

  • Advocate Medical Group

    Niles, Illinois, 60714, United States

  • Ameriderm Research

    Ormond Beach, Florida, 32174, United States

  • Anschutz Cancer Pavilion

    Aurora, Colorado, 80045, United States

  • Ascension Providence Hospital

    Southfield, Michigan, 48075, United States

  • BCCA Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R6V5, Canada

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Baylor Research Institute

    Dallas, Texas, 75246, United States

  • Bend Memorial Clinic

    Bend, Oregon, 97701, United States

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211, United States

  • CHU de Quebec-L'Hotel-Dieu de Quebec

    Québec, G1R2J6, Canada

  • CISSS de la Montérégie - Centre

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Cancer Solutions

    Dallas, Texas, 75231, United States

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256, United States

  • Center for Clinical Studies

    Houston, Texas, 77004, United States

  • Center for Pharmaceutical Research

    Kansas City, Missouri, 64114, United States

  • Central Kentucky Research Associates

    Lexington, Kentucky, 40509, United States

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Durham Regional Cancer Centre

    Oshawa, Ontario, L1G2B9, Canada

  • East Carolina University

    Greenville, North Carolina, 27834, United States

  • GenesisCare USA of Florida

    Jacksonville, Florida, 32204, United States

  • Harry & Jeanette Weinberg Cancer Institute @ Franklin Square

    Baltimore, Maryland, 21237, United States

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703, United States

  • Hillcrest Hospital (Cleveland Clinic)

    Mayfield Heights, Ohio, 44124, United States

  • Independence Family Health Center (Cleveland Clinic)

    Independence, Ohio, 44131, United States

  • Inova Schar Cancer Center

    Fairfax, Virginia, 22031, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Investigative Clinical Research of Indiana

    Indianapolis, Indiana, 46260, United States

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224, United States

  • John Theurer Cancer Center/ Hackensack Medical Center

    Hackensack, New Jersey, 07601, United States

  • MD Anderson Cancer Center-Orlando

    Orlando, Florida, 32806, United States

  • Mayo Clinic Cancer Center, Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • McGlinn Cancer Institute, Reading Hospital

    West Reading, Pennsylvania, 19611, United States

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506, United States

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

  • Mount Sinai School of Medicine

    New York, New York, 10032, United States

  • Multicare Institute for Research & Innovation

    Tacoma, Washington, 98405, United States

  • Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Premier Health Partners Clinical Trials Research Alliance

    Dayton, Ohio, 45431, United States

  • Princess Margaret Hospital, Department of Medical Oncology

    Toronto, Ontario, M5G 2M9, Canada

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Royal Victoria Hospital

    Montreal, Quebec, H4A3J1, Canada

  • Rutgers Cancer Institute of NJ

    New Brunswick, New Jersey, 08901, United States

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794, United States

  • St. Louis University Hospital

    St Louis, Missouri, 63110, United States

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

    San Francisco, California, 94117, United States

  • Sutter Cancer Center

    Sacramento, California, 95816, United States

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The Huntsman Cancer Institute, University of Utah Health Care

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

  • The Melanoma Center at the Washington Cancer Institute

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

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

    Germantown, Tennessee, 38138, United States

  • Thomas Jefferson Medical Oncology

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA Hematology & Oncology Clinic

    Los Angeles, California, 90095, United States

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Minnesota Masonic Cancer Institute

    Minneapolis, Minnesota, 55455, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • University of Virginia Hospital

    Charlottesville, Virginia, 22908, United States

  • Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • Wake Forest University School of Medicine, Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.