Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients (MAVIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Polynoma LLC
Sponsor:
Information provided by (Responsible Party):
Polynoma LLC
ClinicalTrials.gov Identifier:
NCT01546571
First received: February 26, 2012
Last updated: February 26, 2015
Last verified: February 2015
History of Changes

February 26, 2012
February 26, 2015
April 2012
July 2016   (final data collection date for primary outcome measure)
Recurrence Free Survival (RFS) [ Time Frame: 362 events ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01546571 on ClinicalTrials.gov Archive Site
Overall Survival (OS) [ Time Frame: 472 events ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Melanoma
  • 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
  • Placebo Comparator: POL-103A without API
    Intervention: Biological: POL-103A without API
  • Experimental: POL-103A
    Intervention: Biological: POL-103A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1059
October 2018
July 2016   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact: Deb Jezior (858) 254-8480 debjezior@polynoma.com
United States
 
NCT01546571
103A-301
No
Polynoma LLC
Polynoma LLC
Not Provided
Principal Investigator: Craig Slingluff, M.D. Martha Jefferson Hospital, University of Virginia
Polynoma LLC
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP