Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients
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.
- 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.
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
- 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
- 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
Mayo Clinic principal investigator
Svetomir Markovic, M.D., Ph.D.
Closed for enrollment
Cancer Center Clinical Trials Referral Office