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

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

Tracking Information

• First Submitted Date: February 26, 2012
• First Posted Date: March 7, 2012
• Last Update Posted Date: November 13, 2019
• Actual Study Start Date: April 2012
• Estimated Primary Completion Date: January 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Melanoma

Intervention

• 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

• Placebo Comparator: POL-103A without API
  Intervention: Biological: POL-103A without API
• Experimental: POL-103A
  Intervention: Biological: POL-103A

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 24, 2019): 1224
• Original Estimated Enrollment (submitted: March 1, 2012): 1059
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: January 1, 2025 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT01546571
• Other Study ID Numbers: 103A-301
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Polynoma LLC
• Study Sponsor: Polynoma LLC
• Collaborators: Not Provided

Investigators

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

• PRS Account: Polynoma LLC
• Verification Date: November 2019