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
Investigator: Bill G Schmidt, MD
Sponsor: Polynoma LLC
Contact: Jennifer Montgomery, 541-706-6590 or firstname.lastname@example.org
Location: Bend, Oregon (Central Oregon)
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.
- 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
- 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)
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