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

Phase 3

Terminated

• Conditions: Melanoma
• Interventions: Biological: POL-103A without API; Biological: POL-103A

• Registration Number: NCT01546571
• Lead Sponsor: Polynoma LLC

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 available

Study Timeline

• Study First Submitted: 2012-02-26
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-07
• Study Start: 2012-05-01
• Primary Completion: 2021-04-29
• Study Completion: 2021-06-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 504

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POL-103A without API	POL-103A without API	-
POL-103A	POL-103A	-

Primary Outcome Measures

Name	Time	Method
Recurrence Free Survival (RFS)	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	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.

Trial Locations

Locations (65)

Ironwood Cancer and Research Centers; 🇺🇸 Chandler, Arizona, United States

University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Highlands Oncology Group; 🇺🇸 Fayetteville, Arkansas, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Beverly Hills Cancer Center; 🇺🇸 Beverly Hills, California, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

The Angeles Clinic and Research Institute; 🇺🇸 Los Angeles, California, United States

UCLA Hematology & Oncology Clinic; 🇺🇸 Los Angeles, California, United States

Ventura County Hematology Oncology Specialists; 🇺🇸 Oxnard, California, United States

Sutter Cancer Center; 🇺🇸 Sacramento, California, United States

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