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

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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 - 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)

Last updated:

9/15/2013

NCT ID:

NCT01546571

IRB Number:

12-002308