Imaging biomarkers of response to immunotherapy in patients with malignant mesothelioma
- Conditions
- MesotheliomaCancer - Lung - Mesothelioma
- Registration Number
- ACTRN12623000632695
- Lead Sponsor
- The University of Western Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
To be eligible for inclusion in Stage 1, patient must satisfy ALL of the following:
•Written informed consent
•Able to undergo study procedures
•Life expectancy > 12 weeks
•Minimum age 18 years, no maximum age
•Body weight > 30kg
•Patients with histologically or cytologically confirmed mesothelioma, pleural or peritoneal
•No prior immune checkpoint therapy
•Estimated glomerular filtration rate (eGFR) > 60ml/min
•An Eastern Cooperative Group Oncology Group (ECOG) performance score of 0-2
•Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
•Male or female patients of reproductive potential who are employing an effective method of birth control
To be eligible for inclusion in Stage 2, patient must satisfy ALL of the following:
•Written informed consent
•Minimum age > 18, no maximum age
•Body weight > 30kg
•Histologically confirmed malignant pleural mesothelioma
•Planned to undergo systemic treatment incorporating checkpoint blockade for their disease
•eGFR > 60ml/min
•ECOG performance status 0-1
•Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
•Male or female patients of reproductive potential who are employing an effective method of birth control
Patients will be excluded from the Stage 1 study if ANY of the following apply:
•Currently receiving chemotherapy or radiotherapy
•Pregnant or breastfeeding at the time of study enrolment
•Inadequate English language to complete study outcome measures
•Geographically inaccessible for follow-up
•Less than 18 years of age
•Prior immune checkpoint inhibitor therapy
•Known sensitivity or allergy to any study agents
•Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
•Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent
•Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
Patients will be excluded from the Stage 2 study if ANY of the following apply:
•Any previous therapy or condition that precludes treatment of mesothelioma with checkpoint blockade therapy
•Prior immune checkpoint inhibitor therapy
•Recent major surgery within 4 weeks prior to entry into the study that would prevent administration of study drug
•Another concurrent active malignancy which may have the potential to confound imaging findings.
•Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
•Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
•Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method