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: July 29, 2016

Last verified: July 2016

History of Changes

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:

MedlinePlus related topics: Melanoma

Genetic and Rare Diseases Information Center resources: Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

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 80 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546571

Show 82 Study Locations

Sponsors and Collaborators

Polynoma LLC

Investigators


Principal Investigator:	Craig Slingluff, M.D.	University of Virginia Hospital

More Information


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:	July 29, 2016
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 September 23, 2016

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