A Study to Test the Benefit of a New Anti-cancer Treatment in Patients With Unresectable Advanced Melanoma (PREDICT)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||GSK2132231A Antigen-Specific Cancer Immunotherapeutic as First-line Treatment of Patients With Unresectable Metastatic Melanoma|
- Overall survival rate of patients with the predictive gene signature [ Time Frame: 1 year after the registration of the last patient with the predictive gene signature ]
- Progression-free survival (PFS) [ Time Frame: 5 years ]
- Progression status [ Time Frame: At 6 months and 1 year after the registration of the last patient with the predictive gene signature ]
- Overall survival (OS) [ Time Frame: 5 years ]
- Time to Treatment Failure (TTF) [ Time Frame: 5 years ]
- Best clinical response [ Time Frame: 5 years ]
- Duration of response for patients with Complete Response, Partial Response or Stable Disease status [ Time Frame: 5 years ]
- Evaluation of humoral immune response in terms of antibody titers, seropositivity and seroconversion rates against the investigational treatment [ Time Frame: 5 years ]
- Evaluation of cellular immune response against the investigational treatment [ Time Frame: 5 years ]
- Occurrence of adverse events [ Time Frame: 30 days after the last treatment administration ]
- Occurrence of serious adverse events and autoimmunity [ Time Frame: 5 years ]
|Study Start Date:||August 2009|
|Study Completion Date:||April 2015|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Single Group
Patients will receive a treatment consisting of 24 injections of the GSK2132231A immunotherapeutic
Biological: Immunotherapeutic GSK2132231A
Other Name: MAGE-A3 ASCI
In this study, patients were to receive a maximum of 24 doses of recMAGE-A3 + AS15 according four cycles over a period of four years. An active follow-phase (up to five years after registration into the study) was planned for all patients.
As of Amendment 2, there will no longer be an active follow-up of patients after discontinuation or completion of the treatment. The study will end approximately 30 days after the last dose will be administered.
In addition, no more biological samples will be collected for protocol research purposes. For each biological sample already collected in the scope of this study and not tested yet, testing will not be performed by default, except if a scientific rationale remains relevant.
Blood sampling for safety monitoring as per protocol will continue.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942162
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|