Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma

A Phase I Open-label Study of the Safety and Immunogenicity of Escalating Doses of Lipovaxin-MM, a Novel Melanoma Immunotherapeutic, in Patients With Metastatic Melanoma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01052142

Enrollment

Registered

2010-01-20

Start date

2009-09-30

Completion date

2012-03-31

Last updated

2012-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Melanoma, Cancer vaccines

Brief summary

The purpose of this study is to determine whether Lipovaxin-MM, a new anti-cancer vaccine, is safe and effective in improving the body's ability to destroy cancer cells in patients with metastatic melanoma.

Interventions

BIOLOGICALLipovaxin-MM

Patients will receive three doses of Lipovaxin-MM by intravenous infusion at intervals of four weeks OR patients will receive 4 doses of Lipovaxin-MM by intravenous infusion at weekly intervals

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Patients with incurable stage IV malignant melanoma for which no standard or curative therapy exist OR patients locoregionally recurrent melanoma (including local metastases, in transit metastases and satellitosis) where surgery is not the best therapeutic option. * Must be able and willing to provide written informed consent. * Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Life expectancy of ≥12 weeks. * Female subjects must be of non-child-bearing potential or using appropriate contraception. * Positive test for cell mediated immunity. Key

Exclusion criteria

* Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before entry and stable without steroid treatment for at least 4 weeks. * Previous immunotherapy (except IL-2 or interferon-based therapy) for melanoma. * Inadequate bone marrow reserve. * Serum bilirubin ≥1.2 times the upper limit of normal. * In absence of metastases, liver transaminase levels greater than 1.5 times the upper limit of normal. * If metastases are evident, liver transaminase levels 2.5 times the upper limit of normal will be acceptable. * Inadequate renal function. * Evidence of severe or uncontrolled systemic diseases. * Unresolved toxicity ≥CTC Grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor. * Participation in a trial of an investigational agent within the prior 30 days. * HIV infection. * Immunosuppressive therapy including corticosteroids within 4 weeks of screening. * Pregnant or breast-feeding females.

Design outcomes

Primary

Measure	Time frame	Description
Adverse events	Within 84 days after first dose	—
Immunogenicity	Within 42 days of first dose	antigen specific immune responses will be monitored

Secondary

Measure	Time frame	Description
Anti-cancer activity (RECIST criteria)	Within 84 days of first dose	assessed every 6 weeks of study

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026