Trial | NCT01546571  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    pol-103a ...

  • Study Participants

    504
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.
Study Started
May 01
2012
Primary Completion
Apr 29
2021
Study Completion
Jun 30
2021
Last Update
Dec 08
2021

Biological POL-103A

POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs

Biological POL-103A without API

Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs

POL-103A without API Placebo Comparator

POL-103A Experimental

Criteria 

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)
No Results Posted