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

PI: Troy H. Guthrie, Jr.

Disease

  • Skin Cancer

Contact

North Florida / Jacksonville: Rhonda Calhoun (904) 427-1217

Topics

  • Skin Cancer
  • Melanoma

Sponsors

Polynoma LLC

Number

MAVIS Melanoma

Investigational vaccine to prevent recurrence after surgical resection of stage IIB, IIC or III melanoma. Status: Enrollment On HoldAges Eligible for Study: 18 Years to 80 Years (Adult, Senior)Genders Eligible for Study: Both 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 1Exclusion 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)