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About
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.
Full description
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.
Enrollment
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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 for NY-ESO-1 expression screening and gene profiling on resected tumor tissue and for the complete study has been obtained from the patient prior to shipment of the sample for expression testing and prior to the performance of any other 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 NY-ESO-1, as determined by real-time quantitative reverse transcription polymerase chain reaction (RT-PCR) analysis or any updated technique on fresh tissue sample(s).
Eastern Cooperative Oncology Group performance status of 0 or 1.
The patient has normal organ functions as shown by all of the following:
These tests must be done no more than 3 weeks before the first ASCI administration.
Female patients of non-childbearing potential may be enrolled in the study.
Female patient of childbearing potential may be enrolled in the study, if the patient:
In the view of the investigator, the patient can and will comply with the requirements of this protocol.
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33 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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