This trial is active, not recruiting.

Condition melanoma
Treatment immunotherapeutic gsk2132231a
Phase phase 2
Sponsor GlaxoSmithKline
Start date May 2009
End date November 2014
Trial size 24 participants
Trial identifier NCT00896480, 111473


The clinical objective of this clinical trial is to examine the clinical activity in terms of tumor response and time to treatment failure of the immunotherapeutic product GSK2132231A when given to patients with unresectable and progressive metastatic cutaneous melanoma. The safety of the treatment will also be assessed just as its immunogenicity in terms of the humoral and cellular immune response induced by the GSK2132231A immunotherapeutic. Translational research objectives are to assess the effects of the study treatment in terms of various biological variables.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients will receive a treatment consisting of 24 injections of the experimental GSK2132231A immunotherapeutic
immunotherapeutic gsk2132231a MAGE-A3 ASCI
Administration by intramuscular injection

Primary Outcomes

Tumor response defined as objective response (complete or partial), stable disease or mixed response
time frame: After the concluding visit of the last patient
Time to treatment failure defined as the interval from the first administration of the study treatment until the patient is withdrawn from treatment
time frame: After the concluding visit of the last patient
Occurrence of Grade 3 or 4 adverse events possibly related to the study treatment
time frame: After the concluding visit of the last patient
Occurrence of serious adverse events
time frame: After the concluding visit of the last patient
Occurrence of adverse events
time frame: After the concluding visit of the last patient
time frame: At specified time points during the immunization period (20 assessments per patient) and after the concluding visit of the last patient

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. The patient (male or female) has histologically proven, measurable metastatic cutaneous melanoma in one of the following stages according to the American Joint Committee on Cancer classification of 2002: - Stage III in transit, or - Stage III unresectable, or - Stage IV M1a. 2. There has been documented progression of the patient's disease within the 12 weeks before the first administration of study treatment. 3. The patient presents at screening with at least 3 tumor lesions of diameter >= 0.5 mm. 4. Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure. 5. The patient is >= 18 years of age at the time of signature of informed consent. 6. The patient's tumor shows expression of MAGE-A3 gene in at least one of the two tumor biopsies performed at baseline. 7. The patient's ECOG performance status is 0 or 1. 8. The patient has normal organ functions, as assessed by standard laboratory criteria. 9. 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 the entire study treatment period and for 2 months after completion of the treatment injection series. 10. In the view of the investigator, the patient can and will comply with the requirements of the protocol. Exclusion Criteria: 1. The patient has at any time received systemic (bio)-chemotherapy 2. The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy and immunomodulating agents. 3. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents. 4. The patient has received any cancer immunotherapeutic containing a MAGE A3 antigen or any cancer immunotherapeutic for his/her metastatic disease. 5. Use of any investigational or non-registered product (drug or vaccine) other than the study treatment within the 30 days preceding the first dose of study treatment, or planned use during the study period. 6. 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. 7. History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product. 8. The patient has an autoimmune disease such as, but not limited to, neuroinflammatory autoimmune diseases, systemic lupus erythematosus, and inflammatory bowel disease 9. The patient has a family history of congenital or hereditary immunodeficiency. 10. The patient is known to be positive for the human immunodeficiency virus (HIV). 11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures. 12. 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. 13. For female patients: the patient is pregnant or lactating.

Additional Information

Official title Clinical Activity, Safety and Immunogenic Properties of Cancer Immunotherapeutic GSK2132231A in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.