The Australasian Malignant PLeural Effusion (AMPLE) Trial – 3

Study Outline

The purpose of this study is to determine if an indwelling catheter is more effective than surgical pleurodosis in treating malignant pleural effusion. It is hoped this research will help to provide effective symptom control with minimal intervention for those with malignant pleural effusion.

What’s Involved

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

• Arm 1: Indwelling pleural catheter. A long term catheter is inserted under the skin in order to allow ongoing drainage of the pleural fluid. Participants will then be given instructions to undergo a daily drainage regimen for 14 days at home.
• Arm 2: Surgical pleurodesis. Participants will be given key-hole surgery to remove fluid and facilitate lung re-expansion.

Participants will then be followed up at discharge, 14 days, monthly for 6 months and then every 3 months up to one year post-procedure. These visits will include completion of Quality of Life questionnaires, a chest xray, an ultrasound (if thought necessary) and if you are at the lead site (Sir Charles Gairdner Hospital) a review of your Actigraphy logs up to 6 months after discharge.

Eligibility

You may be eligible for this study if you are an adult who is suffering from symptomatic proven pleural malignancy or an otherwise unexplained pleural effusion.

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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.

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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.

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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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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.

TheraP: A randomised phase 2 trial of 177-Lutetium-Prostate Specific Membrane Antigen-617 (177Lu-PSMA617) theranostic versus cabazitaxel in progressive metastatic castration resistant prostate cancer (ANZUP1603)

The primary purpose of this trial is to evaluate the efficacy and safety of a new radionuclide therapy (177Lu-PSMA617) for advanced prostate cancer, in comparison to the standard care, cabazitaxel.

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A Phase II Study of Durvalumab and Tremelimumab in combination with Neoadjuvant Carboplatin and Paclitaxel in newly diagnosed women with advanced high grade Serous Ovarian, Fallopian Tube and Peritoneal Cancers “iPRIME”

Ovarian cancer is the second most common gynaecological malignancy and the most common cause of gynaecological cancer death in Australia. The majority of women are diagnosed with advanced disease, where standard treatment includes surgery followed by six cycles of adjuvant platinum-based chemotherapy. The purpose of this research project is to test how safe and effective the combination treatment of durvalumab and tremelimumab in combination with standard chemotherapy is as a treatment for patients with ovarian, fallopian tube or peritoneal cancers.

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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.

Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma

The objective of the study is to induce a meaningful progression-free survival benefit in patients with Malignant Pleural Mesothelioma (MPM) after progression on first line standard platinum doublet chemotherapy, by treating with nivolumab and ipilimumab with or without UV1 vaccine.

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A pilot study to evaluate the safety and immunogenicity of a personalised tumour neo-antigen peptide vaccine strategy in patients with completely resected non-small cell lung cancer

This is a pilot study to evaluate the safety of a personalized tumour neo-antigen peptide vaccine strategy in non-small cell lung cancer (NSCLC).

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