Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients (MAVIS)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Polynoma LLC
Sponsor:
Polynoma LLC
Information provided by (Responsible Party):
Polynoma LLC
ClinicalTrials.gov Identifier:
NCT01546571
First received: February 26, 2012
Last updated: February 26, 2015
Last verified: February 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Melanoma |
Biological: POL-103A Biological: POL-103A without API |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Polynoma LLC:
Primary Outcome Measures:
- Recurrence Free Survival (RFS) [ Time Frame: 362 events ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Overall Survival (OS) [ Time Frame: 472 events ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1059 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | October 2018 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
- Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546571
Show 40 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546571
Contacts
| Contact: Deb Jezior | (858) 254-8480 | debjezior@polynoma.com |
Show 40 Study Locations
Sponsors and Collaborators
Polynoma LLC
Investigators
| Principal Investigator: | Craig Slingluff, M.D. | Martha Jefferson Hospital, University of Virginia |
More Information
No publications provided
| Responsible Party: | Polynoma LLC |
| ClinicalTrials.gov Identifier: | NCT01546571 History of Changes |
| Other Study ID Numbers: | 103A-301 |
| Study First Received: | February 26, 2012 |
| Last Updated: | February 26, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas |
ClinicalTrials.gov processed this record on March 01, 2015