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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 26, 2012
First Posted Date  ICMJE March 7, 2012
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE April 2012
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
Recurrence Free Survival (RFS) [ Time Frame: 362 events ]
Change History Complete list of historical versions of study NCT01546571 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
Overall Survival (OS) [ Time Frame: 472 events ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: POL-103A without API
    Intervention: Biological: POL-103A without API
  • Experimental: POL-103A
    Intervention: Biological: POL-103A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 24, 2019)
1224
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2012)
1059
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01546571
Other Study ID Numbers  ICMJE 103A-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Polynoma LLC
Study Sponsor  ICMJE Polynoma LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Craig Slingluff, M.D. University of Virginia Hospital
PRS Account Polynoma LLC
Verification Date November 2019

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