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

Polynoma

Status and phase: Terminated; Phase 3

Conditions: Melanoma

Treatments: Biological: POL-103A without API; Biological: POL-103A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01546571

103A-301

Details and patient eligibility

About

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.

Enrollment: 504 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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
• Use of biologic response modifiers within 60 days of first dosing
• Subjects with history of other malignancy within past 5 years (with exceptions)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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504 participants in 2 patient groups, including a placebo group

POL-103A without API

Placebo Comparator group

Treatment:

Biological: POL-103A without API

POL-103A

Experimental group

Treatment:

Biological: POL-103A