Durvalumab with first-line chemotherapy in previously untreated malignant pleural mesothelioma (DREAM): a multicentre, single-arm, phase 2 trial with a safety run-in

Full description

Dataset includes 54 male and female patients 18 years or over with a histological or cytological diagnosis of malignant pleural mesothelioma (MPM) that was not amendable to curative surgical resection, and with measurable disease as per modified RECIST criteria for assessment of response in malignant pleural mesothelioma. Participants had an ECOG status of 0-1, and brain metastases needed to be controlled in the opinion of the treating clinician. Participants must not have had prior chemotherapy, immunotherapy or other systemic anti-cancer for MPM and not have had prior radiotherapy to disease sites. • Baseline patient assessments were blood tests for renal and liver function, haematology, urinalysis, coagulation studies, thyroid function tests, hepatitis B and C serology, and electrocardiography. • Clinical assessments were done at screening, baseline, and then every 3 weeks during study treatment. • Laboratory tests were done every 3 weeks, at the end of treatment, and then every 4 weeks to 90 days from the last dose. • Adverse events were recorded from the first dose of study treatment to 90 days following the last dose of study treatment, and were classified and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Survival status was recorded every 3 months after completing study treatment. • Tumour imaging by CT of the chest and upper abdomen was done at baseline and every 6 weeks until week 48, and then every 12 weeks thereafter until disease progression was confirmed. Response and progression were assessed by both mRECIST19 (for malignant pleural mesothelioma) and modified Response Evaluation Criteria in Solid Tumors for immunotherapy (iRECIST) • Archived diagnostic tumour samples were assessed centrally for PDL1 expression • Only databased items are available as .csv files. Imaging files are not available.

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