Overview

This trial is active, not recruiting.

Condition melanoma
Treatments pol-103a, pol-103a without api
Phase phase 3
Sponsor Polynoma LLC
Start date April 2012
End date July 2016
Trial size 1059 participants
Trial identifier NCT01546571, 103A-301

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
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
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

Primary Outcomes

Measure
Recurrence Free Survival (RFS)
time frame: 362 events

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: 472 events

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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)

Additional Information

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
Principal investigator Craig Slingluff, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Polynoma LLC.
Location data was received from the National Cancer Institute and was last updated in July 2016.