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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Polynoma LLC
ClinicalTrials.gov Identifier:
NCT01546571
First received: February 26, 2012
Last updated: September 15, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Melanoma
Biological: POL-103A
Biological: POL-103A without API
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Polynoma LLC:

Primary Outcome Measures:
  • Recurrence Free Survival (RFS) [ Time Frame: 362 events ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 472 events ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1059
Study Start Date: April 2012
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: POL-103A without API 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
Experimental: POL-103A 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546571

  Show 35 Study Locations
Sponsors and Collaborators
Polynoma LLC
Investigators
Principal Investigator: Craig Slingluff, M.D. Martha Jefferson Hospital, University of Virginia
  More Information

No publications provided

Responsible Party: Polynoma LLC
ClinicalTrials.gov Identifier: NCT01546571     History of Changes
Other Study ID Numbers: 103A-301
Study First Received: February 26, 2012
Last Updated: September 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 17, 2014