Melanoma Clinical Trial
Official title:
Study of GSK2241658A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
The purpose of this study is to investigate the safety, immunogenicity and clinical activity of GSK2241658A antigen-specific cancer immunotherapeutic (ASCI) for the treatment of patients with non-operable and progressing metastatic cutaneous melanoma.
In this study, patients were to receive a maximum of 24 doses of recNY-ESO-1 + AS15 ASCI
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 3, there will no longer be an active follow-up of patients after
discontinuation or completion of the treatment. The study will end 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.
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