Data

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

Thoracic Oncology Group Australasia (TOGA)

Dataset 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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Subjects

Cancer |

Related Study

A phase 2 trial of durvalumab with first line chemotherapy in mesothelioma with a safety run in.

Brief Summary

This study will investigate the effectiveness of durvalumab in combination with standard chemotherapy for mesothelioma. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have had a diagnosis of malignant pleural mesothelioma that is not amenable to curative surgical resection. Study details All participants in the study will receive standard first-line chemotherapy for mesothelioma and the new treatment, durvalumab, intravenously on day 1 of each 3 week cycle for a maximum number of 18 cycles. Participants will be followed-up for a minimum of 12 months to determine progression free survival and tumour response rate. Durvalumab is an antibody (a type of human protein) that works by blocking a body substance called PD-L1. Blocking PD-L1 helps the body’s immune system to attack cancer cells. Research has shown that durvalumab can slow tumour growth and shrink tumours in some people with cancer. We plan to enrol 54 participants in this study from hospitals and clinics throughout Australia. Durvalumab is currently an experimental treatment. This means that it is not yet approved for the treatment of mesothelioma, or any other condition, in Australia, or in other countries.

Inclusion Criteria

  • 1. Adults (18 years or over) with a histological or cytological diagnosis of malignant pleural mesothelioma that is not amendable to curative surgical resection 2. Measurable disease as per modified RECIST criteria for assessment of response in malignant pleural mesothelioma 3. ECOG performance status of 0 or 1 4. Tumour tissue (FFPE) available for PD-L1 testing at a central laboratory 5. Must have measurable disease without prior radiotherapy to these sites 6. Adequate bone marrow function (done within 28 days prior to registration and with values within the ranges specified below). Blood transfusions are permissible. * Haemoglobin greater than or equal to 90 g/L * Absolute neutrophil count greater than or equal to 1.5 x 109/L * Platelets greater than or equal to 100 x 109/L 7. Adequate liver function (done within 28 days prior to registration and with values within the ranges specified below): * Alanine transaminase less than or equal to 3 x upper limit of normal (ULN), unless liver metastases or invasion are present, in which case it must be less than or equal to 5 x ULN * Aspartate aminotransferase less than or equal to 3 x ULN, unless liver metastases or invasion are present, in which case it must be less than or equal to 5 x ULN * Total bilirubin less than or equal to 1.5 x ULN (except participants with Gilbert’s Syndrome, who are eligible with bilirubin less than or equal to 2.5 ULN) 8. Adequate renal function (done within 28 days prior to registration and with values within the ranges specified below): * Serum creatinine less than or equal to 1.5 x ULN or * Creatinine clearance (CrCl) greater than or equal to 60 mL/min (use Cockroft-Gault formula) 9. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments 10. Signed, written informed consent 11. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative serum pregnancy test done within 24 hours prior to enrolment. Men must have been surgically sterilised or use a (double if required) barrier method of contraception if they are sexually active with a woman of child bearing potential.

Study Type

  • Interventional

Ethics Approval

The data-sharing statement for this study is currently unavailable.