Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients (MAVIS)
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ClinicalTrials.gov Identifier: NCT01546571 |
Recruitment Status :
Terminated
(Planned interim analysis showed a strong signal of efficacy in a pre-specified patient population. Fast track designation was granted and a new, redesigned pivotal trial will be conducted.)
First Posted : March 7, 2012
Last Update Posted : December 8, 2021
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Sponsor:
Polynoma LLC
Information provided by (Responsible Party):
Polynoma LLC
Tracking Information | ||||
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First Submitted Date ICMJE | February 26, 2012 | |||
First Posted Date ICMJE | March 7, 2012 | |||
Last Update Posted Date | December 8, 2021 | |||
Actual Study Start Date ICMJE | May 1, 2012 | |||
Actual Primary Completion Date | April 29, 2021 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Recurrence Free Survival (RFS) [ Time Frame: 362 events ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
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 |
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Condition ICMJE | Melanoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Slingluff CL, Lewis KD, Andtbacka R, Hyngstrom J, Milhem M, Markovic SN, Bowles T, Hamid O, Hernandez-Aya L, Claveau J, Jang S, Philips P, Holtan SG, Shaheen MF, Curti B, Schmidt W, Butler MO, Paramo J, Lutzky J, Padmanabhan A, Thomas S, Milton D, Pecora A, Sato T, Hsueh E, Badarinath S, Keech J, Kalmadi S, Kumar P, Weber R, Levine E, Berger A, Bar A, Beck JT, Travers JB, Mihalcioiu C, Gastman B, Beitsch P, Rapisuwon S, Glaspy J, McCarron EC, Gupta V, Behl D, Blumenstein B, Peterkin JJ. Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence. J Immunother Cancer. 2021 Oct;9(10). pii: e003272. doi: 10.1136/jitc-2021-003272. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
504 | |||
Original Estimated Enrollment ICMJE |
1059 | |||
Actual Study Completion Date ICMJE | June 30, 2021 | |||
Actual Primary Completion Date | April 29, 2021 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | |||
Current Responsible Party | Polynoma LLC | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Polynoma LLC | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Polynoma LLC | |||
Verification Date | December 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |