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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 12-002308
    NCT ID: NCT01546571
    Sponsor Protocol Number: 103A-301

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Prior diagnosis of Stage I, IIA, IIB, IIC, or III melanoma
  • Surgical resection within 90 days of first dosing
  • Persons with positive sentinel nodes can be randomized to complete lymph node disection then observation
  • ECOG performance status 0 or 1

Exclusion Criteria:

  • Any prior melanoma treatment other than surgery or regional irradiation
  • Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
  • Use of biologic response modifiers within 60 days of first dosing
  • Subjects with history of other malignancy within past 5 years (with exceptions)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Svetomir Markovic, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20115517

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