Spots Global Cancer Trial Database for Evaluation of a New Vaccine Treatment for Patients With Metastatic Skin Cancer

Study Description

Brief Summary: The purpose of this clinical study is to examine the safety, immunogenicity and clinical activity of the immunotherapeutic product GSK2302025A (also referred to as recPRAME + AS15 Antigen-Specific Cancer Immunotherapeutic \[ASCI\]) administered as a first line treatment in patients with unresectable and progressive metastatic cutaneous melanoma.

Detailed Description: In this study, patients were to receive a maximum of 24 doses of recMAGE-A3 + AS15 according to 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. This protocol summary has been impacted by protocol amendment 3, so there will no longer be an active follow-up of patients after discontinuation or completion of the study 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. Sampling for safety monitoring as per protocol will continue.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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