MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma

Study of GSK1203486A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

This study is being done to evaluate the safety and the clinical activity of MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in patients with unresectable and progressive metastatic cutaneous melanoma.

Study Overview

• Status: Terminated
• Conditions: Melanoma
• Intervention / Treatment: Biological: GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1425DTG
      • GSK Investigational Site
    • Quilmes, Buenos Aires, Argentina, 1878
      • GSK Investigational Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000KZE
      • GSK Investigational Site
• Greece
  • Athens, Greece, 11527
    • GSK Investigational Site
  • Athens, Greece, 185 47
    • GSK Investigational Site
• Norway
  • Oslo, Norway, 0310
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patient with histologically proven, measurable metastatic cutaneous melanoma, and with documented progressive disease within the 12 weeks before the first administration of study treatment.
• Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
• Patient is >= 18 years of age at the time of signature of the informed consent.
• The patient's tumor shows expression of MAGE-A3 gene
• ECOG performance status of 0 or 1.
• The patient has normal organ functions
• If the patient is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the injection series.
• In the view of the investigator, the patient can and will comply with the requirements of the protocol.

Exclusion Criteria:

• The patient has at any time received systemic (bio-)chemotherapy (except for isolated limb perfusion, as long as this was performed at least 4 weeks before first study treatment administration).
• The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy and immunomodulating agents.
• The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
• The patient received any cancer immunotherapeutic containing a MAGE-A3 antigen or any cancer immunotherapeutic for his/her metastatic disease.
• The patient has received any investigational or non-registered drug or vaccine other than the study medication within the 30 days preceding the first ASCI injection or it is planned that (s)he will receive such a drug during the study period.
• The patient has (or has had) previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
• History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
• The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
• The patient has a family history of congenital or hereditary immunodeficiency.
• The patient is known to be positive for the Human Immunodeficiency Virus (HIV).
• The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
• The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
• For female patients: the patient is pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GSK1203486A Group; Patients received 4 cycles of MAGE-A3 product as follows: Cycle 1: 6 doses, each given at a 2-week interval,; Cycle 2: 6 doses, each given at a 3-week interval; Cycle 3: 4 doses, each given at a 6-week interval; Cycle 4: 4 doses, each given at a 3-month interval followed by 4 doses, each given at a 6-month interval. The MAGE-A3 product was administered intramuscularly in the deltoid or lateral regions of the thighs, alternately on the right and left sides.

Biological: GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A; IM administration in the deltoid or lateral regions of the thighs, alternately on the right and left sides.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE)	The assessment was made as per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade refers to the severity of the AE. The CTCAE version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, as follows: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.	During the entire study, up to 2.5 years per patient
Number of Subjects With Any Serious Adverse Events (SAEs).	SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	During the entire study, up to 2.5 years per patient
The Rate of Objective Clinical Response.		At the time of analysis.

Secondary Outcome Measures

Outcome Measure	Time Frame
The Rate of Stable Disease.	At the time of analysis.
The Rate of Mixed Response.	At the time of analysis.
Time to Study Treatment Failure.	At the time of analysis.
Progression-free Survival.	At the time of analysis.
Progression-free Survival After Initial SPD.	At the time of analysis.
Documentation of Any Toxicity.	During the entire study, up to 2.5 years per patient
Immunogenicity at Defined Time Points.	At 13 defined time points.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2008
• Primary Completion (Actual): January 19, 2011
• Study Completion (Actual): January 19, 2011

Study Registration Dates

• First Submitted: June 25, 2008
• First Submitted That Met QC Criteria: June 26, 2008
• First Posted (Estimate): June 27, 2008

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: MAGE-A3; ASCI; metastatic,; Melanoma,; Antigen-Specific Cancer Immunotherapeutic,; tumor antigen,
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 110551; 2007-005203-18 (EudraCT Number)