A Randomised Phase II Open-label Study With a Phase Ib Safety lead-in Cohort of ONCOS-102 an Immune-priming GM-CSF Coding Oncolytic Adenovirus and Pemetrexed/Cisplatin in Patients With Unresectable Malignant Pleural Mesothelioma

Brief description of study

The trial is an open-label, parallel group, multicentre trial that will recruit a total of 30 patients with malignant pleural mesothelioma. The trial will be conducted in 2 phases: a non-randomised safety phase and a randomised phase. The safety phase will consist of a lead-in cohort of 6 patients treated with ONCOS 102 and pemetrexed/cisplatin. The randomised phase will not commence until the DSMB has deemed the safety lead-in data appropriate for continuation. A total of 24 patients will be included in the randomised phase; 14 patients will be randomised to receive ONCOS 102 and pemetrexed/cisplatin, and 10 patients will receive pemetrexed/cisplatin alone. The trial's main objectives are determination of safety, immune activation, clinical response and the correlation between clinical outcome and the immunological data.

Clinical Study Identifier: NCT02879669

Recruitment Status: Closed

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