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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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | Biological: POL-103A Biological: POL-103A without API | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 504 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 : | May 1, 2012 |
Actual Primary Completion Date : | April 29, 2021 |
Actual Study Completion Date : | June 30, 2021 |

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 |
- 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.
- 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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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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

Principal Investigator: | Craig Slingluff, M.D. | University of Virginia Hospital |
Responsible Party: | Polynoma LLC |
ClinicalTrials.gov Identifier: | NCT01546571 |
Other Study ID Numbers: |
103A-301 |
First Posted: | March 7, 2012 Key Record Dates |
Last Update Posted: | December 8, 2021 |
Last Verified: | December 2021 |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |