What is a clinical trial?
Clinical trials give patients access to potentially life-saving treatments, and contribute to the development of new and improved treatments.
A clinical trial is a research study where people can volunteer to undergo new treatments, devices or tests to help prevent, detect, treat or manage diseases or medical conditions.
Over the past two years, we have expanded our clinical trials in cancer, renal, orthopaedic surgery/theatre and palliative care, with a view to expand our clinical trial offering. This now means our patients won’t have to keep travelling to Melbourne to go on a clinical trial.
This growth has come from a commitment to improving health outcomes and opportunities for our community, and providing more workforce opportunities in research and clinical trials.
Below is a list of the clinical trials LRH is currently involved in.
Arthritis
Trial Name: SOLAREA
Open to recruitment? Yes
Principal investigator: Dr Anthony Boers
About the trial: Our arthritis trial is looking at how well particular pro and pre-biotics in patients work on patients with early rheumatoid arthritis. This trial is supervised by Dr Anthony Boers.
Cardiology
Trial Name: Poseidon
Open to recruitment? Opening shortly
Principal investigator: Dr Derk Pol
About the trial: Dr Derk Pol is overseeing this new trial to collect information about the number of people with cardiovascular disease who have high levels of inflammation throughout the body. Cardiovascular disease is a general name for diseases that affect the heart or the blood vessels. This trial studies how often people with cardiovascular disease have high levels of inflammation and if there are common characteristics of patients with high levels of inflammation.
Cardiology
Trial Name: Zeus
Open to recruitment? Open to recruitment
Principal investigator: A/Prof Alastair Wright
About the trial: The ZEUS study is to see if ziltivekimab (a new drug) can be used to treat people with cardiovascular disease, chronic kidney disease and inflammation. Completed studies showed that ziltivekimab can lower inflammation, which may have a positive effect on cardiovascular disease.
The ZEUS study will see if ziltivekimab can reduce the risk of having cardiovascular events, for example heart attack and stroke.
A/Prof Alastair Wright is leading this study.
Dermatology
Trial Name: Coast-1 (Teletrial)
Open to recruitment? Yes
Principal investigator: Dr Shree Vidhya Nagendram (AI – Site Lead)
About the trial: This is a sponsored tele-trial overseen by Shree Vidhya Nagendram at LRH. It is to look at how well a medication given by subcutaneous injection works in participants aged 18 years and older with moderate-to-severe excema.
Diabetes
Trial Name: Best DKA
Open to recruitment? Yes
Principal investigator: Dr Pritish Korula
About the trial:
The George Institute for Global Health is sponsoring this Diabetes trial overseen by Dr Pritish Korula. It is run between the Emergency Department and Critical Care and is trialling the use of two different medications for patients presenting with moderate to severe diabetic ketoacidosis (DKA).
Endocronology
Trial Name: FLASH GM
Open to recruitment? Opening shortly
Principal investigator: Dr Shree Vidhya Nagendram
About the trial: This exciting new study being overseen by Dr Shree Vidhya Nagendram will be centred around glucose management in Indigenous Australians with Type 2 Diabetes, using the flash glucose monitoring system.
Stroke
Trial Name: Librexia Stroke
Open to recruitment? Yes
Principal investigator: A/Prof Alastair Wright
About the trial: The purpose of this study is to see if an investigational medication in addition to standard of care, is safe and effective in reducing the risk of future ischaemic stroke. The study is looking for participants who have recently experienced an ischaemic stroke or TIA and is overseen by A/Prof Alastair Wright.
Breast cancer
Trial Name: EXPERT
Open to recruitment? Open to recruitment
Principal investigator: Dr Chia May Wong
About the trial: Breast Cancer Trials are sponsoring a randomised trial of radiation therapy versus observation following breast conserving surgery and endocrine therapy in patients with early breast cancer. Expert is overseen by Dr Chia May Wong.
Breast cancer
Trial Name: CAPTURE
Open to recruitment? Open to recruitment
Principal investigator: Dr Mahesh Iddewala
About the trial: Overseen by Dr Mahesh Iddewala and sponsored by Breast Cancer Trials, this trial is suited for women and men with a particular type of breast cancer. Patients will be randomised to evaluate two different treatments.
Colon cancer
Trial Name: DYNAMIC RECTAL
Open to recruitment? Closed to recruitment – patients in follow-up
Principal investigator: Dr Sachin Joshi
About the trial: This trial is for people who have rectal cancer that has recently been removed by surgery. The purpose of this study is to use samples of blood and the tumour tissue removed as part of surgery to see whether using a specific genetic test called “circulating tumour DNA” in addition to the best standard of care is a more effective way of deciding the best method of further treatment, which may include chemotherapy. The study is led by Dr Sachin Joshi.
Colorectal cancer
Trial Name: ALT-TRACC
Open to recruitment? Open to recruitment
Principal investigator: Dr Azim Jalali
About the trial: This Clinical Trial evaluates the optimal combination of therapies for the treatment of metastatic bowel cancer (cancer that has spread to distant organs and is visible on scans). The aim of this study is to evaluate the optimal combination of therapies in metastatic colorectal cancer, whilst taking into account the side effect profile of these treatments. The Study is led by Dr Azim Jalali.
Complex Genomic Profiling In Patients with Advanced Cancer
Trial Name: Cancer Statewide/iPREDICT-2
Open to recruitment? Yes
Principal investigator: Dr. Sachin Joshi
About the trial: iPredict-2 is a genomic testing study for patients with advanced cancer who have a blood test to help the doctors to see if there is a targeted therapy which may be of benefit to them. The study is overseen by Dr. Sachin Joshi, who is a medical Oncologist.
Haematology
Trial Name: FRAIL-M
Open to recruitment? Open to recruitment
Principal investigator: Dr Tricia Wright
About the trial: This study is looked after by Dr Tricia Wright and is for patients with Relapsed Multiple Myeloma (RMM). This disease and it’s treatments can cause adverse effects that make it difficult for patients to stay on treatment. The hope in this study is that using real-time reporting of PROMs will improve the amount of time that participants remain on their treatment, and in turn improve their outcomes.
Haematology - Myeloma
Trial Name: MY PROMPT-2
Open to recruitment? Open to recruitment
Principal investigator: Dr Tricia Wright
About the trial: This study is looked after by Dr Tricia Wright and is for patients with Relapsed Multiple Myeloma (RMM). This disease and its treatments can cause adverse effects that make it difficult for patients to stay on treatment. The hope in this study is that using real-time reporting of PROMs will improve the amount of time that participants remain on their treatment, and in turn improve their outcomes.
Haematology - Myeloma
Trial Name: RIDDLE-M-X
Open to recruitment? Open to recruitment
Principal investigator: Dr Sueh-Li-Lim
About the trial: This Myeloma trial sponsored by the Australasian Myeloma Research Consortium is evaluating the addition of a medication to the standard of care therapy for patients with newly diagnosed multiple myeloma. Overseen by Dr Sueh-Li Lim.
Haematology - Multiple Myeloma
Trial Name: SeaLAND (ALLG-MM23)
Open to recruitment? Open to recruitment
Principal investigator: Dr Sueh-Li-Lim
About the trial: This trial overseen by Dr Sueh-Li Lim and sponsored by the Australasian Leukaemia and Lymphoma group is a randomised trial two medications post stem cell transplant for patients with newly diagnosed multiple myeloma.
Leukemia
Trial Name: 393-419-00041-OTSUKA
Open to recruitment? Open to recruitment
Principal investigator: Dr Michael Ashby
About the trial: This clinical trial is for patients suffering with either Myelodysplastic Syndrome (MDS), Acute Myeloid Leukaemia (AML) or Chronic Myelomonocytic Leukaemia (CMML). The purpose of this study is to understand participant preference for mode of administration of treatment. Currently, it is assumed more patients will prefer an oral treatment, taken by mouth, over a subcutaneous injection, an injection under the skin but this hasnt been confirmed. The information obtained from this study may help towards understanding how patients would like to be treated for their condition and the main reasons why they prefer one treatment to another, helping doctors in the future to provide care for blood cancer patients that is more suitable to their needs. Dr Michal Ashby is the haematologist leading this trial.
Lung cancer
Trial Name: ORIGAMA
Open to recruitment? Open to recruitment
Principal investigator: Dr Hieu Chau
About the trial: The research study led by Dr Hieu Chau is testing a digital patient monitoring software (the Roche Digital Patient Monitoring atezolizumab Module, hereafter referred to as the patient monitoring app) that is designed to track symptoms for people receiving anti-cancer treatment containing atezolizumab.
Lymphoma
Trial Name: BGB-3111-08
Open to recruitment? Open to recruitment
Principal investigator: Dr Amanda Omerod
About the trial: This clinical trial is for patients who have been diagnosed with follicular lymphoma (FL) or marginal zone lymphoma (MZL) and whose lymphoma has not gotten better with recent treatment (refractory) or did get better but has returned (relapsed). The research project is testing a new treatment for relapsed or refractory Follicular or Marginal Zone Lymphoma. The new treatment is called Zanubrutinib (BGB-3111). The lead doctor for this study is Amanda Ormerod.
Myeloma
Trial Name: PRO-DVD
Open to recruitment? Closed to recruitment – patients in follow up
Principal investigator: Dr Amanda Omerod
About the trial: This trial overseen by Dr Amanda Omerod is for patients with Lymphoma. The patients are randomised into two groups and treated with different medication who then report the outcomes and symptoms whilst on that medication.
Prostate cancer
Trial Name: Cancer Statewide/iPREDICT-2
Open to recruitment? Closed to recruitment – patients in follow up
Principal investigator: Dr Bhavini Shah (AI – Site Lead)
About the trial: This trial sponsored by the Australian and NZ Urogenital and Prostate Cancer Trials Group and is a teletrial with the Alfred. It led at LRH by Dr Bhavini Shah, Medical Oncologist. The trial looks at the efficacy of adding Darolutamide to radiation and androgen deprivation therapy in high-risk prostate cancer patients.
Prostate cancer
Trial Name: GUIDE
Open to recruitment? Open to recruitment
Principal investigator: Dr Hieu Chau
About the trial: The purpose of this study is to see if a prostate cancer marker in the blood (mGSTP1) can be used to guide chemotherapy treatment. Based on the level of this blood marker, some men may be able to have breaks in treatment rather than having chemotherapy continuously which is the current standard of care. This study will tell us if having these treatment breaks guided by mGSTP1 can improve how men feel during treatment while still treating the prostate cancer effectively. Dr Hieu Chau is the Principal Investigator.
Prostate cancer
Trial Name: IRONMAN (Teletrial)
Open to recruitment? Opening shortly
Principal investigator: Dr Wee Ong (AI – Site Lead)
About the trial: This research study will establish an international Registry of people with advanced prostate cancer. There are two main types of advanced prostate cancer; (1) Prostate cancer that has spread and has not yet been treated with hormone therapy is called metastatic hormone-sensitive prostate cancer (mHSPC); and (2) Prostate cancer that is continuing to grow despite hormone therapy to lower testosterone levels, which is called castration-resistant prostate cancer (CRPC), and might be detectable by scans or sometimes on the basis of blood tests alone.
Skin cancer - Melanoma
Trial Name: RELATIVITY-127
Open to recruitment? Open to recruitment
Principal investigator: Dr Quan Tran
About the trial: This study is for patients who have unresectable (unable to be removed with surgery) or metastatic (when the cancer has spread from the place where it first formed in the body) melanoma. The study is testing an experimental treatment for these types of cancer. The experimental treatment is Nivolumab together with Relatlimab, the study drug. The lead doctor for this trial is Dr Quan Tran.
Useful links:
For more information about clinical trials, visit Cancer Council Victoria’s clinical trial section https://www.cancervic.org.au/cancer-information/treatments/clinical-trials/clinical-trials-explained.html
