The Australasian Malignant PLeural Effusion (AMPLE)-4 Trial: Topical Antibiotic Prophylaxis for Infections of Indwelling Pleural Catheters in Patients with Malignant Pleural Effusions

Study Outline

This is a phase 1/2 randomised controlled trial comparing the use of preventative antibiotic cream versus standard care in patients with malignant pleural effusion (MPE) who have an indwelling pleural catheter (IPC). The study will enrol approximately 418 patients across multiple centres in Australia, New Zealand, and Malaysia.

The trial aims to determine whether regular application of topical mupirocin (antibiotic cream) around the catheter exit site can reduce infection rates. This is important because while IPCs are effective for managing MPE, they can increase the risk of infection, impacting patient outcomes and quality of life.

What’s Involved

Participants will be randomly assigned to one of two treatment arms:

• Mupirocin Group: Participants will apply mupirocin 2% cream around the IPC exit site after each drainage (at least twice weekly) for 6 months or until the IPC is removed. They will receive instructions and pictures showing how to apply the cream properly.
• Standard Care Group: Participants will receive regular IPC care without antibiotic cream.

All participants will:

• Receive standard education on IPC aftercare
• Have access to support services and a direct phone line to respiratory staff
• Be followed weekly for 6 months or until death
• Continue their regular medical treatments as prescribed by their doctors
• Have all infections and hospital stays recorded and reviewed

Eligibility

You may be eligible for this study if you:

• Are 19 years or older
• Require an IPC for control of malignant pleural effusion
• Are able to comply with study procedures

You may not be eligible for this study if you:

• Have an allergy to mupirocin
• Have had an infection in the same side of the chest within the past three months
• Are unable to provide informed consent
• Are unable to comply with the study protocol

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Integrative Supportive Care Trial to Enhance Physical Activity in Malignant Pleural Effusion (The Australasian Malignant PLeural Effusion (AMPLE)-5 Trial)

Study Outline

This randomised controlled trial investigates the effects of an integrated supportive care program on physical activity levels and other outcomes in patients with malignant pleural effusion (MPE). Approximately 100 participants will be randomly assigned to either the intervention group, receiving a 12-week multidisciplinary supportive care program addressing nutrition, physical activity, and psychological well-being, or the control group, receiving standard medical care with referral to supportive services if indicated.

The primary outcome is the change in daily step count measured by an accelerometer, with secondary outcomes including quality of life, malnutrition risk, psychological well-being, and symptom burden.

What’s Involved

Participants will be randomly assigned to one of two groups:

• Integrated Supportive Care Program Group: Participants will attend counselling sessions at weeks 1, 4, and 8, each lasting about an hour. The multidisciplinary team, consisting of a dietitian, exercise physiologist/physiotherapist, and clinical psychologist/specially trained nurse, will develop individualised care plans based on the participant’s needs. Sessions will be conducted via telehealth or in-person if required.
• Standard Care Group: Participants will receive standard medical care as per their attending physician, with referral to supportive services if indicated. They will receive phone calls from the research team at weeks 4 and 8 to discuss any adverse events.

Both groups will continue to receive standard medical care from their treating physician throughout the study, including access to support services. The study will last for 13 weeks, with assessments conducted at baseline and post-intervention.

Eligibility

You may be eligible for this study if you:

• Are 19 years of age or older.
• Have a confirmed diagnosis of malignant pleural effusion.
• Have an estimated survival of at least 3 months.
• Are willing to comply with the study procedures.

You may not be eligible for this study if you:

• Are younger than 19 years old.
• Are unable to provide informed consent.
• Are unable to comply with the study protocol.
• Are pregnant or lactating.
• Have an ECOG performance status greater than 3.

Click here for trial details

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma (eVOLVE-Meso)

Study Outline

This is a phase 3, open-label, randomised study comparing the investigational drug volrustomig (MEDI5752) in combination with carboplatin and pemetrexed chemotherapy versus standard of care treatment in approximately 600 patients with advanced unresectable pleural mesothelioma.

Patients will be randomly assigned in a 1:1 ratio to receive either volrustomig plus chemotherapy or the investigator’s choice of standard treatment regimens based on the patient’s tumour histology (epithelioid or non-epithelioid). The study’s primary endpoint is overall survival, with key secondary endpoints including progression-free survival, response rates, patient-reported outcomes, and safety.

What’s Involved

Participants will be randomly assigned to one of two treatment arms:

• Arm 1: Volrustomig + Carboplatin + Pemetrexed. Participants will receive the investigational drug volrustomig (MEDI5752) administered as an IV infusion in combination with the chemotherapy drugs carboplatin and pemetrexed, also given via IV infusion.
• Arm 2: Investigator’s choice of standard care. Participants will receive either nivolumab plus ipilimumab immunotherapy or platinum plus pemetrexed chemotherapy, depending on their type of mesothelioma (epithelioid or non-epithelioid). All drugs will be administered via IV infusion.

The study will last approximately 52 months. Participants will be followed for overall survival, progression-free survival, response rates, duration of response, patient-reported outcomes, adverse events, and drug concentrations in the blood.

Eligibility

You may be eligible for this study if you:

• Are 18 years of age or older.
• Have histologically proven pleural mesothelioma that is advanced and unresectable.
• Have measurable disease.
• Have adequate bone marrow, liver and kidney function.
• Have a good performance status.

You may not be eligible for this study if you:

• Have an autoimmune or inflammatory disorder.
• Have an uncontrolled illness.
• Have untreated or progressive brain metastases.
• Have active tuberculosis, hepatitis B, hepatitis C, or poorly controlled HIV.
• Have had prior treatment with chemotherapy, radiation, immunotherapy or hormonal therapy for mesothelioma.

Click here for trial details

The Western Australia Asbestos Review Program

Study Outline

In this study, researchers will conduct yearly clinical assessments to track the health outcomes of individuals from Western Australia who have had exposure to asbestos over an extended period.

What’s Involved

Those who opt to participate in this study will be required to undergo an annual comprehensive evaluation, which includes an assessment of their general and lung health, tests to measure lung function, and a chest CT scan using an ultra-low dose to detect any asbestos-related lung diseases. Additionally, the Western Australian Asbestos Review Program (ARP) will conduct blood tests to identify potential markers that could aid in the early diagnosis of lung diseases. Each yearly appointment is expected to last approximately two hours. The ARP does not restrict participation based on age or the duration since the initial asbestos exposure, as the study aims to monitor as many exposed individuals as possible for an extended period.

The researchers anticipate that this study will yield valuable insights, enabling healthcare professionals to better characterise, diagnose, and comprehend diseases associated with asbestos exposure. The findings from this research may ultimately contribute to improving the health outcomes of future patients who have been impacted by asbestos exposure

Eligibility

You may be eligible for this study if you meet the following criteria: are a Western Australian resident aged 16 or above, and either have a history of occupational asbestos exposure, have previously lived in Wittenoom (the site of the asbestos mine), or have experienced a cumulative asbestos exposure exceeding 3 months and/or have radiological findings indicating the presence of an asbestos-related disease.

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Imaging biomarkers of response to immunotherapy in malignant mesothelioma

Study Outline

Immunotherapy targeting immune checkpoint molecules is revolutionising treatment of mesothelioma. A recent international clinical trial showed that people whose tumours showed more ‘PD-L1′ on biopsy seemed to benefit more, but this was not a close enough association to reliably direct treatment. This study will non-invasively image PD-L1 in people with mesothelioma before and during immunotherapy treatment. This may help us understand how treatments change PD-L1 epression over time and better guide treatment.

What’s Involved

Positron Emission Tomography (PET)/Computed Tomography (CT) with fluoro-deoxyglucose (FDG) is a standard scan used to detect mesothelioma. PET/CT scanning is done by injecting a small amount of radioactive material (called a tracer) through a vein, then imaging your body by passing you through a PET/CT scanner whilst you lie on your back. Participants will be asked to have between two and four ⁸⁹Zr-durva PET/CT scans to see where PD-L1 is present.

This trial will not affect your standard treatment. You will continue to receive the treatment recommended by your doctor.

Eligibility

You may be eligible for this trial if you have been diagnosed with pleural or peritoneal mesothelioma, you have not yet begun chemotherapy or radiotherapy and you have not received prior immune checkpoint blockade therapy.

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ATTAC (Antigen-targeted therapy against cancer)

Study Outline

This is a phase 1 pilot study evaluating a personalised cancer vaccine in patients with completely resected early-stage non-small cell lung cancer (NSCLC). The vaccine is customised for each patient and contains 5-10 peptides identified from their own tumour, designed to stimulate their immune system against potential remaining cancer cells.

The study aims to evaluate both the safety of this personalised vaccine approach and how well it stimulates an immune response. The trial will enroll approximately 6 patients and will be conducted at Sir Charles Gairdner Hospital in Western Australia.

What’s Involved

All participants will receive the personalised vaccine treatment.

The vaccine will be administered as a subcutaneous injection containing 500mcg – 1000mcg of synthetic peptides mixed with Montanide as an adjuvant

Treatment schedule consists of:

• First 8 weeks: Doses given every 2 weeks (4 doses)
• Next 16 weeks: Doses given every 4 weeks (4 doses)

Participants will be monitored with blood tests and clinical reviews before each dose

Total follow-up period is 52 weeks, with specific monitoring visits at weeks 5, 7, 11, 15, 19, 23, 35 and 52

Eligibility

You may be eligible for this study if you:

• Are 18 years or older
• Have been diagnosed with NSCLC that has been completely removed by surgery
• Have adequate organ and bone marrow function
• Have completed any required adjuvant chemotherapy
• Have an ECOG performance status of ≤1
• Have a life expectancy of >24 weeks

You may not be eligible for this study if you:

• Have received chemotherapy, radiotherapy, or biologic therapy within the last 21 days
• Have a history of serious adverse reactions to vaccines
• Have significant autoimmune disease
• Require systemic corticosteroids or immunosuppressive medications
• Have HIV, active hepatitis B or hepatitis C
• Are pregnant or breastfeeding

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Linear Phase I Trials

Linear Clinical Research is a Phase 1 clinical trials unit which is on the Sir Charles Gairdner Hospital campus. People with mesothelioma may be eligible to participate in these clinical trials, usually after referral from their medical oncologist.

The International Association for the Study of Lung Cancer (IASLC) Prospective Malignant Pleural Mesothelioma Staging Project (9th Edition)

This study is collecting information that will improve the staging of mesothelioma. Earlier editions have led to changes in guidelines for the management of malignant mesothelioma.

The Australasian Malignant PLeural Effusion (AMPLE) Trial – 3: Comparing IPC with Talc Pleurodesis versus VATS

This randomised study compares two approaches for managing malignant pleural effusion: indwelling pleural catheter (IPC) with talc pleurodesis versus video-assisted thoracoscopic surgery (VATS).

The trial aims to determine which approach is more effective at preventing fluid re-accumulation and reducing the need for additional procedures. The study has completed the recruitment of its participants.