Date: 2013-03-07
Type of information: Initiation of the trial
phase: 2
Announcement: initiation
Company: Oxford Biomedica (UK)
Product: TroVax® (MVA-5T4) in combination with first-line chemotherapy agents pemetrexed and cisplatin
Action mechanism: immunotherapy product/therapeutic vaccine. TroVax® is a therapeutic vaccine that stimulates the immune system to destroy cancerous cells expressing the 5T4 tumour antigen which is present on most solid tumours. The product comprises a modified vaccinia virus Ankara (MVA) vector, encoding the 5T4 antigen.
Disease: mesothelioma
Therapeutic area: Cancer - Oncology
Country: UK
Trial details: The Phase II study, entitled “SKOPOS”, will be led by Dr Jason Lester at Velindre Cancer Centre in Cardiff, Wales, with Dr Zsuzsanna Tabi as Co-Investigator, and will enrol 26 patients with malignant pleural mesothelioma (MPM). The study will evaluate whether TroVax® is active in the treatment of MPM, assessed by measuring anti-5T4 immune responses following treatment in combination with pemetrexed and cisplatin. The study will also assess secondary measures of clinical benefit including progression-free survival, objective response rate and overall survival at six and 12 months. Pemetrexed-cisplatin will be given into a vein in the arm (intravenously) every 3 weeks. The TroVax® vaccine will be given as an injection into the shoulder muscle (intramuscularly) 3 weeks before chemotherapy starts, one week before chemotherapy starts, then every 3 weeks. Each participant will receive 4 chemotherapy and 9 vaccine treatments if they complete the planned trial schedule. (NCT01569919)
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