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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Source Study

Trial acronym


Trial ID





Phase 1 / Phase 2


Commercial sector/Industry,AstraZeneca Pty Ltd

Scientific enquiries

Prof Anna Nowak

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 cyc ....
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Key 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 (don ....
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Key Exclusion Criteria

1. Prior chemotherapy or other systemic anti-cancer or immunotherapy for MPM 2. Active, known or suspected autoimmune disease. Participants are not excluded if they have vitiligo, type 1 diabetes mellitus, Grave’s disease, residual hypothyroidism due to an autoimmune condition requiring only hormone replacement, or psoriasis not requiring systemic treatment within the past 2 years. 3. Any condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone or equivalent dos ....
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Can healthy volunteers participate?




Sample Size    54

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Malignant Pleural Mesothelioma (MPM).

Condition code    Cancer


Intervention code Treatment: Drugs

A safety run-in phase will be conducted to confirm the tolerability of the standard dose of durvalumab. The safety run-in of the study will be done at a limited number of study sites, once the durvalumab dose is confirmed recruitment will be expanded to all sites for the remainder of the trial. Durvalumab 1125mg (dose to be confirmed by safety run in) AND chemotherapy (cisplatin 75mg/m2 and pemetrexed 500 mg/m2) are all given intravenously (IV) on day 1, repeated every 3 weeks for a maximum of 6 ....
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Control group Uncontrolled

No control group.


Outcome: Progression free survival at 6 months (PFS6) according to mRECIST for MPM.
Timepoint: 6 months PFS measured from the date of trial entry until the date that disease progression is first observed, or the date of death from any cause, whichever occurs first.

Study Protocol: Not Available
Data Dictionary: Data dictionary

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

Participant data supporting the publication results. Consent to provide case level data has not been obtained. IPD may be shared where a specific secondary research proposal receives a waiver of consent from our ethics committee.

When will data be available?

Data are available for an indefinite time Start date: January 2024 End date: Unknown

Available to whom?

Data are potentially available to any research organisation or researcher with a valid ethics approval to conduct desired research based in Australia and New Zealand.

Available for what types of analyses?

Any type of analysis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see