Overview

This trial is active, not recruiting.

Condition melanoma
Treatments gsk 2132231a, placebo
Phase phase 3
Sponsor GlaxoSmithKline
Start date December 2008
End date June 2015
Trial size 1351 participants
Trial identifier NCT00796445, 111482

Summary

The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor.

This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Not Applicable
gsk 2132231a
IM solution, a course of 13 injections will be administered over 27 months
(Placebo Comparator)
Not Applicable
placebo
IM solution, a course of 13 injections will be administered over 27 months

Primary Outcomes

Measure
Disease Free Survival
time frame: Once the pre-defined number of events is reached

Secondary Outcomes

Measure
Overall Survival
time frame: At the time of analysis
Disease-free specific survival
time frame: At the time of analysis
Distant metastasis-free survival
time frame: At the time of analysis
Anti-MAGE-A3 and anti-protein D seropositivity status.
time frame: Post-treatment and 1 year after concluding visit.
Occurrence of adverse events including abnormal haematological and biochemical parameters.
time frame: Up to 30 days after each study dose.
Occurrence of serious adverse events and autoimmunity events.
time frame: During the whole study duration up to 30 days after the last administration of study treatment.
Health-related quality of life (utility) assessment using the EuroQoL 5D (EQ-5D) questionnaire.
time frame: At regular intervals from Visit 1 (baseline) till 6 months after the concluding visit or 1 year post-recurrence.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Written informed consent signed. - Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery. - The patient must have been surgically rendered free of disease before the randomization. - Patient is ≥ 18 years old at the time of signing the informed consent form. - The patient's lymph node tumor shows expression of the MAGE-A3 gene. - The patient has fully recovered from surgery. - ECOG performance status of 0 or 1 at the time of randomization. - The patient must have adequate organ functions as assessed by standard laboratory criteria. - If the patient is female, she must be of non-childbearing potential, or practice adequate contraception. - In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol. Exclusion Criteria: - The patient suffers from a mucosal or ocular melanoma. - The patient has or has had any history of in-transit metastases - The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the surgery that qualifies the patient for inclusion in the present trial. - The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents. - Use of any investigational or non-registered product (drug or vaccine) other than the study treatment. - The patient has a history of autoimmune disease. - The patient has a family history of congenital or hereditary immunodeficiency. - The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition. - History of allergic disease or reactions likely to be exacerbated by any component of the treatments. - 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. - The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured. - The patient has an uncontrolled bleeding disorder. - For female patients: the patient is pregnant or lactating.

Additional Information

Official title GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma
Description "http://www.immunotherapyforcancer.info provides information on the cancer immunotherapeutic approach in an easy-to-understand format" "http://www.ascitrials.com gives practical information on the MAGRIT clinical study"
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.