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

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ClinicalTrials.gov Identifier: NCT01546571
Recruitment Status : Active, not recruiting
First Posted : March 7, 2012
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Polynoma LLC

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Melanoma Biological: POL-103A Biological: POL-103A without API Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Actual Study Start Date : April 2012
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence Free Survival (RFS) [ Time Frame: 436 events or approximately 4 years ]
    This is an event driven trial. Recurrence-free survival time (RFS) is computed from the earliest of the date of recurrence or death or, if without recurrence or death, the date last assessed for recurrence without diagnosis of recurrence (censored). The date of recurrence is specified as the first date a recurrence is suspected, which is later confirmed by biopsy.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 432 events or approximately 10 years ]
    Survival time is computed based on the date of death if the subject is known dead or the date last known to be alive (censored). Zero time is the date of randomization.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546571


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Sponsors and Collaborators
Polynoma LLC
Investigators
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Principal Investigator: Craig Slingluff, M.D. University of Virginia Hospital
More Information
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Responsible Party: Polynoma LLC
ClinicalTrials.gov Identifier: NCT01546571     History of Changes
Other Study ID Numbers: 103A-301
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Vaccines
Immunologic Factors
Physiological Effects of Drugs