Cancer Care

Listed below are a selection of research projects currently active within ISLHD.

Multidisciplinary Cancer Care

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Brungs D, Chantrill L, Aghmesheh M, Glasgow A, Presgrave P, Parmar G, Clingan P, Leighton C, Robinson S, CN1-101: A Phase I, Open Label, Multi-Center, Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN1 in Patients with Advanced Solid Tumors or B-cell Lymphoma.
Locations: Wollongong Hospital.

This study is a multicenter, open-label, dose-escalation Phase I study to assess the safety, tolerability, PK profile, and preliminary efficacy of CN1 in patients with advanced solid tumor or B-cell lymphoma, and to determine the MTD and RP2D after administration of CN1.

 

Girgis A, Durcinoska I, Delaney G, Arnold A, Bray V, Using online patient reported outcome assessments to deliver integrated cancer care across South Western Sydney and Illawarra Shoalhaven Local Health District Cancer Services.
Locations: Wollongong Hospital, Shoalhaven District Memorial Hospital, Milton Ulladulla Hospital.
External Partners: Ingham Institute (Liverpool Hospital), South Western Sydney Local Health District.

Demand for cancer services continues to grow. Changing models of care and resource infrastructure are needed. Telehealth and web-based care options are increasingly being adapted and provide a flexible approach to provide essential care to patients. The objective of this project is to develop and implement the PROMPT-Care model of screening in cancer services as “business as usual” across SWSLHD and ISLHD. The project will involve re-design of current models of care by facilitating systematic screening of PROs in routine practice, and will ensure no patients ‘fall through the gaps’ by providing them with appropriate information and referral to services where needed.  

 

Kaadan N, Bell G, Mackay N, Prescribing Patterns of Chemotherapy in New South Wales.
Locations: Illawarra Shoalhaven Local Health District.
External Partners: South Western Sydney Local Health District.

This project aims to evaluate the prescribing patterns of Medical Oncology and Haematology eviQ protocols in NSW.

 

Khasraw M, Brungs D, Gandhidasan S, A randomised phase II study of nivolumab and temozolomide vs temozolomide alone in newly diagnosed elderly patients with glioblastoma (NUTMEG).
Locations: Wollongong Hospital.
External Partners: The University of Sydney.

Patients with GBM, older than 65 yrs have a survival of approximately 9 months. Temozolomide with short course Radiotherapy is a reasonable option for elderly GBM patients. The aim of this study is to test the effectiveness, safety and tolerability of nivolumab in combination with standard adjuvant chemotherapy to see if it improves overall survival.

 

Martin J, Scuffham P, Agar M, Lintzeris N, Eagar K, Lacey J, Grimison P, Chye R, Zielinski R, Dalton C, Galettis P, Lucas C, Liu Z, Schneider J, Mapagu M, Chantrill L, Brungs D, Aghmesheh M, Glasgow A, Clingan P, Singh S, Robinson S, Leighton C, Fox C, Nasser E, Miller A, Fylyk G, Chen J, Gandhidasan S, Presgrave P, Warburton P, Parmar G, Cartwright K, Desai S, King K, Appadoo K, Yeo N, Cannabinoids for Symptom Control in Advanced Cancer, an Open Label Prospective Clinical Trial in NSW (CARE NSW).
Locations: Wollongong Hospital.
External Partners: University of Newcastle, Griffith University, University of Technology Sydney, The University of Sydney, South Eastern Sydney Local Health District, University of Wollongong, Chris O'Brien Lifehouse, Western Sydney University, St Vincent's Hospital Sydney, Orange Hospital, Hunter New England Local Health District.

This study is designed to be a ‘real-world’ clinical study to establish the clinical effects and pharmacokinetic characteristics of THC and CBD containing products in an advanced cancer setting. The key aim of the study is to ensure quality and safety in the implementation of cannabis medicines in the advanced cancer setting by filling/addressing this current clinical evidence gap. This includes early identification and quantification of side effects and risks to health from the use of cannabis medicines. Gathering this evidence in terms of patient outcomes, and understanding drug-drug interactions and adverse events (AE) will, in turn, inform direct and robust guidance for Advanced Cancer patients, general practitioners, prescribers and the public.

 

Rischin D, Miller A, Brungs D, A randomized, placebo controlled double blind study of adjuvant cemiplimab versus placebo after surgery and radiation therapy in patients with high risk cutaneous squamous cell carcinoma.
Locations: Wollongong Hospital, Shoalhaven District Memorial Hospital.
External Partners: Peter MacCullum Cancer Centre.

This research project involves an investigational study drug: Cemiplimab. The main purpose of this research is to determine if cemiplimab will prevent cutaneous squamous cell cancer (cSCC) from returning after surgery and radiation.

 

Spring K, Kaadan N, Carolan M, Villanueva D, Clinical and Translational Informatics System (CTIS).
Locations: Illawarra Shoalhaven Local Health District.
External Partners: Western Sydney University, Ingham Institute, South Western Sydney Local Health District.

To effectively use and protect valuable clinical data a web-accessible real-time information management system has been established. The Clinical and Translational informatics (CTIS) platform (CTIS-Labmatrix) is a customised commercial solution (BioFortis Inc) that is housed in a eHealth approved UNSW secure server and links two NSW Local Health Districts (SWSLHD and ISLHD) enabling scalable clinical data linkage infrastructure. The unique capability of CTIS-Labmatrix  supports multi-site collaboration, patient registration, dynamic and continuously updating of clinical data and data quality assurance linked to a user-friendly data querying tool for reports, data results and hypothesis generation. CTIS-Labmatrix has the flexibility, security and data access control to support fully partitioned studies involving biobanking, investigator driven clinical trials and patient-orientated translational research activities within a single unified secure environment.  

Haematology

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Hertzberg M, Agrawal S, The impact of mobilising regimen on immune reconstitution, progression-free survival and overall survival in myeloma patients treated with bortezomib, cyclophosphamide and dexamethasone induction followed by a high dose melphalan autograft.
Locations: Wollongong Hospital.
External Partners: Prince of Wales Hospital.

This is a collaborative initiative with other Australian haematology departments to perform a retrospective data review of patient treated at Prince of Wales and Wollongong Hospitals. The data being collected will be from patients receiving a specified treatment regimen (Bortezomib, Cyclophosphamide, Dexamethasone) for newly diagnosed multiple myeloma followed by an autologous bone marrow stem cell transplant. The analysis will focus on whether the doses/treatments given prior to transplantation influence stem cell characteristics and patient outcomes.

 

Hiwase D, Presgrave P, Parmar G, Warburton P, Desai S, King K, A Phase 3, open-label, randomised study to compare the efficacy and safety of luspatercept (ACE-536) versus epoetin alfa for the treatment of anemia due to IPSS-R very low, low or intermediate risk of Myelodysplastic Syndromes (MDS) in ESA naive subjects who require red blood cell transfusions - the COMMANDS Trial.
Locations: Wollongong Hospital.

This trial treats anaemia in patients suffering from Myelodysplastic Syndrome (MDS) (very low, low or intermediate risk levels) who have never received an erythropoietin stimulating agent (ESA).

 

McCaughan G, Bryant A, Ho J, Doo NW, Kwok F, Parmar G, Presgrave P, Warburton P, Cartwright K, Desai S, Lenalidomide/bortezomib/dexamethasone therapy: Evaluation of a NSW Harmonised Approach and Review of Toxicity and Outcomes.
Locations: Wollongong Hospital.
External Partners: St Vincent's Hospital (Sydney), Liverpool Hospital, Royal Prince Alfred Hospital, Concord Hospital, Westmead Hospital.

Combined lenalidomide, bortezomib and dexamethasone therapy was listed on the PBS for initial treatment for multiple myeloma in June 2020.  There are a number of published protocols utilising these three agents, some of which use outdated administration strategies which are associated with unacceptable toxicity.  Administration and dose modifications are made frequently but there is little real world data available regarding these different modifications. Clinical Haematologists in New South Wales met and agreed to use a harmonised approach to dosing of this regimen in both fit (i.e. transplant eligible) and unfit (i.e. transplant ineligible) patients.  We seek to audit our outcomes across these sites, in particular to assess toxicity of these regimens.

 

Osborn M, Presgrave P, Parmar G, Warburton P, Cartwright K, Desai S, Phase II Study of Blinatumomab as Induction Therapy in Adolescent and Young Adult Acute Lymphoblastic Leukaemia.
Locations: Wollongong Hospital.

Historically, older adolescents and adult patients with acute lymphoblastic leukaemia (ALL) have poorer outcomes than children with this disease. Detection of minimal residual disease (MRD) provides a way of identifying drug resistance in ALL and hence patients at higher risk of relapse. Studies in adults with ALL have confirmed the significance of MRD detection, but have shown higher numbers of patients with detectable disease in adults compared to children. The main aim is to determine whether adding blinatumomab to the induction of the ALL06 protocol leads to improved MRD negativity rates post induction when compared to a past control cohort treated with the ALL06 induction. It is expected MRD negativity rates in adolescents and young adult ALL patients will significantly improve.

 

Parmar G, Presgrave P, Warburton P, Cartwright K, Desai S, A multi-center, open-label, Phase 1b study to assess the pharmacokinetics, safety, and efficacy of subcutaneous and intravenous isatuximab (SAR650984) in combination with pomalidomide and dexamethasone, in patients with relapsed/refractory multiple myeloma.
Locations: Wollongong Hospital.

This study is planned to evaluate the safety and tolerability (including local injection site tolerability) of isatuximab administered subcutaneously (SC) using infusion pump versus isatuximab administered intravenously (IV) and also to evaluate the phamacokinetics of Isatuximab when given SC and IV in combination with pomalidomide and dexamethasone.

 

Parmar G, Presgrave P, Warburton P, Cartwright K, Desai S, Ai S, Leighton C, Robinson S, MINDSET - Multiple Myeloma Illawarra Shoalhaven Research study.
Locations: Wollongong Hospital, Shoalhaven District Memorial Hospital.

This research study will be conducted across the Illawarra and Shoalhaven Local Health district (ISLHD) and will be the first of its kind in Australia to fully capture retrospective as well as prospective disease and outcome data from the multiple myeloma (MM) patient population. The primary intent of this project is to develop a resource that will allow research into the nature, cause, and clinical outcomes of MM. This study aims to utilise longitudinal clinical data collected from patients with MM; from disease diagnosis prospectively through to disease progression. Specifically, this study will enable the research team to design highly specific therapeutic clinical trials and treatments that will drive quality improvement in both healthcare cost reductions and advancement in patient outcomes; for a patient population with no current curative treatment. 

 

Parmar G, Prince HM, Presgrave P, Warburton P, Cartwright K, Desai S, Leighton C, Robinson S, Phase 1-2 trial evaluating anti-TGFB agent (SAR439459) or pomalidomide in combination with isatuximab and dexamethasone in relapsed or refractory multiple myeloma (RRMM).
Locations: Wollongong Hospital.
External Partners: Epworth Healthcare.

Proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs) have significantly improved survival in patients with multiple myeloma (MM). However, MM eventually becomes refractory to these classes of drugs. Patients with relapsed or refractory MM (RRMM) who have progressed through multiple prior lines of therapy need novel, effective, targeted agents. There is enthusiasm that novel approaches will provide clinical benefit in this challenging population.

 

Patil S, Nagendraprasad S, Cochrane T, Renwick W, Leahy M, Badoux X, Lee D, Chong G, Giri P, Presgrave P, Parmar G, Warburton P, Cartwright K, Desai S, A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma.
Locations: Wollongong Hospital.
External Partners: The Alfred Hospital, Liverpool Hospital, Gold Coast Hospital, Sunshine Hospital, Royal Perth Hospital, St George Hospital, Box Hill Hospital, Northern Hospital Victoria, Royal Adelaide Hospital.

This study is designed to investigate whether tafasitamab and lenalidomide as add-on to rituximab provides improved clinical benefit compared with lenalidomide as add-on to rituximab alone in patients with  R/R Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma.

 

Polizotto M, Withers B, Andersen C, Sasson S, Swaminathan S, Hertzberg M, Bloch M, Long G, Presgrave P, Parmar G, Warburton P, Cartwright K, Desai S, Coronavirus Outcomes Registries in Immunocompromised Individuals Australia (CORIA): a multisite registry and optional biorepository in people with SARS-CoV-2 infection and selected conditions affecting immune function.
Locations: Wollongong Hospital.
External Partners: St Vincent's Hospital (Sydney), Prince of Wales Hospital, Westmead Hospital, Western Sydney University, Blacktown Hospital, Holdsworth House Medical Practice, Melanoma Institute of Australia.

To our knowledge, since the emergence of COVID-19, no studies have described the clinical and biological outcomes in people with key conditions affecting immune function, including primary immunodeficiencies, acquired immunodeficiencies associated with immunosuppressive therapy, HIV infection, malignancy be it cancer or blood, organ transplantation, and those on immune checkpoint inhibitor therapy. These groups may have particular vulnerabilities either to SARS-CoV-2 infection or to serious consequences; some agents used in these contexts may have unexpected therapeutic benefits. Given the speed and death of the emerging COVID-19 epidemic, there is an urgent and critical need to establish its impact in these  populations to plan for clinical and research needs. The existence of established networks in Australia, including in community settings, conducting studies in these groups provides a unique opportunity to rapidly gather actionable information on COVID-19 illness and outcomes in people with immune function alterations.

 

Presgrave P, Getta B, Ramanathan S, Ting S, Cochrane T, Gray J, Parmar G, Warburton P, Cartwright K, Desai S, VIALE-M - Randomized, Open-label, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Azacitidine Versus Best Supportive Care as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy.
Locations: Wollongong Hospital, Shoalhaven District Memorial Hospital.
External Partners: Liverpool Hospital, St George Hospital, Box Hill Hospital, Gold Coast University Hospital, Toowoomba Base Hospital.

Acute myeloid leukemia (AML) is an aggressive hematologic malignancy typically defined by the World Health Organization (WHO) as a myeloid neoplasm with 20% or more blasts in the peripheral blood or bone marrow. It is the most common form of acute leukemia in adults, with a projected estimate of 19,520 new cases and 10,670 deaths in the United States (US) in 2018. Of all types of leukemia, AML has the lowest survival rate and accounts for the largest number of deaths. This study will evaluate the safety and efficacy of venetoclax in combination with azacitidine (AZA) compared to best supportive care (BSC) as maintenance therapy in subjects with AML in first remission after conventional chemotherapy

 

Quach H, Spencer A, Khot A, Presgrave P, Parmar G, Warburton P, Cartwright K, Desai S, A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination with Lenalidomide Plus Dexamethasone (Treatment A), or Bortezomib Plus Dexamethasone (Treatment B) in Participants with Relapsed / Refractory Multiple Myeloma.
Locations: Wollongong Hospital.
External Partners: St Vincent's Hospital (Melbourne), The Alfred Hospital, Peter MacCallum Cancer Centre, Royal Melbourne Hospital.

The purpose is to evaluate the safety of a drug at different doses and how well it works to treat people with Multiple Myeloma when taken together with Lenalidomide Plus Dexamethasone, or Bortezomib Plus Dexamethasone.

 

Quach H, Parmar G, Janowski W, Lim A, Hua V, Presgrave P, Warburton P, Cartwright K, Desai S, A Phase 3 randomized, open label, multicenter study of isatuximab (SAR650984) in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with high-risk smouldering multiple myeloma (SMM).
Locations: Wollongong Hospital.
External Partners: St Vincent's Hospital (Melbourne), Calvary Mater Newcastle, Austin Hospital, Liverpool Hospital.

Smoldering multiple myeloma (SMM) is an asymptomatic plasma cell disorder, which is a precursor stage of myeloma disease and is diagnosed before any symptoms occur. This is a Phase 3 randomized, open-label, multicenter study of isatuximab in combination with lenalidomide and dexamethasone (ILd) versus lenalidomide and dexamethasone (Ld) in participants with high-risk SMM. The primary objective of this randomized study is progression free survival (PFS)

 

Quach H, Campbell P, Ling S, Low M, Ward CM, Spencer A, Presgrave P, Parmar G, Warburton P, Cartwright K, Desai S, A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide plus Lowdose Dexamethasone (pom/dex) in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3).
Locations: Wollongong Hospital.
External Partners: St Vincent's Hospital (Melbourne), University Hospital Geelong, Royal North Shore Hospital, Liverpool Hospital, The Alfred Hospital, Monash Medical Centre.

The study is to test if the investigational study treatment, called belantamab mafodotin, can help participants with worsening MM who have already failed at least two other treatments (called relapsed/refractory MM). The results will be compared with a comparator study treatment combining pomalidomide and low-dose dexamethasone (pom/dex).

 

Quach H, Fay K, Campbell P, Kenealy M, Low M, Simpson J, Forsyth C, Lee E, Lambshead J, Hertzberg M, Presgrave P, Parmar G, Warburton P, Cartwright K, Desai S, A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8).
Locations: Wollongong Hospital.
External Partners: St Vincent's Hospital (Melbourne), Port Macquarie Base Hospital, St Vincent's Hospital (Sydney), Monash Health, University Hospital Geelong, The Canberra Hospital, Gosford Hospital, Wyong Hospital, Prince of Wales Hospital.

Multiple myeloma (MM) is cancer of plasma cells in the bone marrow. Currently, most MM patients develop resistance (become refractory) to existing therapies and die of relapse. Belantamab mafodotin is an experimental antibody-medication combination which targets a specific part of cancer cells which is called B-cell maturation antigen (BCMA). Belantamab mafodotin targets BCMA to find and destroy MM cancer cells. This study is being done to learn more about how to treat relapsed/refractory MM and to compare belantamab mafodotin to an approved drug called bortezomib. Each drug will be given in combination with two other approved medications called pomalidomide and dexamethasone. The safety and effectiveness of belantamab mafodotin combination will be compared with the bortezomib combination.

 

Spencer A, Lim A, Gibbs S, Presgrave P, Bryant A, Cannell P, Ward C, Janowski W, Weber N, Augustson B, Ho J, Parmar G, Warburton P, Cartwright K, Desai S, DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared with the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants with Relapsed/Refractory Multiple Myeloma.
Locations: Wollongong Hospital.
External Partners: The Alfred Hospital, Austin Hospital, Box Hill Hospital, Liverpool Hospital, Calvary Mater Newcastle, Royal Brisbane and Women's Hospital, Fiona Stanley Hospital, Sir Charles Gardiner Hospital, Royal Prince Alfred Hospital.

Multiple myeloma (MM) is cancer of plasma cells in the bone marrow. Currently, most MM patients develop resistance (become refractory) to existing therapies and die of relapse. Belantamab mafodotin is an experimental antibody-medication combination which targets a specific part of cancer cells which is called B-cell maturation antigen (BCMA). This study is being done to learn more about how to treat relapsed/refractory MM and to compare belantamab mafodotin to an approved drug called daratumumab. Each drug will be given in combination with two other approved medications called bortezomib and dexamethasone. The safety and effectiveness of belantamab mafodotin combination will be compared with the daratumumab combination

 

Thant A, D'Rozario J, Forsyth C, Hamad N, Johnston A, Sungala N, Shuttleworth C, Presgrave P, Tan YL, Vanguru V, Ku M, Gregory G, Chong G, Ratnasingam S, Renwick W, Hawkes E, Narayana M, Wight J, Giri P, Leahy M, Cannell P, Parmar G, Warburton P, Cartwright K, Desai S, King K, Cashman H, Leighton C, Robinson S, A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed diffuse large B-cell lymphoma (DLBCL).
Locations: Wollongong Hospital.
External Partners: Calvary Mater Newcastle, The Canberra Hospital, Gosford Hospital, St Vincent's Hospital Sydney, Westmead Hospital, Liverpool Hospital, St George Hospital, Nepean Hospital, Royal Prince Alfred Hospital, St Vincent's Hospital Melbourne, Monash Health, Ballarat Health Services, University Hospital Geelong, Sunshine Hospital, Box Hill Hospital, Sunshine Coast University Hospital, Townsville University Hospital, Royal Adelaide Hospital, Royal Perth Hospital, Fiona Stanley Hospital.

This phase 3, multicenter, randomized, double-blind, placebo-controlled study is designed to investigate whether tafasitamab plus lenalidomide as add-on therapy to R-CHOP provides improved clinical benefit compared to R-CHOP in patients with newly-diagnosed high-intermediate and high-risk diffuse large B-cell lymphoma (DLBCL).

 

Trotman J, Presgrave P, Warburton P, Desai S, Cartwright K, Parmar G, PETReA: Phase 3 evaluation of PET-guided, Response-Adapted therapy in patients with previously untreated, high tumour burden follicular lymphoma.
Locations: Wollongong Hospital.
External Partners: Australasian Leukaemia and Lymphoma Group.

PETReA is a non-blinded phase 3 RCT in which all patients receive initial treatment with rituximab (R) plus chemotherapy and are then separated into two groups based on their response as determined by contrast-enhanced CT (ceCT) to assess anatomical response and FDG PET to assess metabolic response. The primary outcome is progression-free survival (PFS) from the point of randomisation.

 

Wei A, Fong CY, Chua CC, Presgrave P, Parmar G, Warburton P, Cartwright K, Desai S, Robinson S, Tubaro T, Leighton C, The International AML Platform Consortium (IAPC) trial.
Locations: Wollongong Hospital.
External Partners: The Alfred Hospital, Fiona Stanley Hospital, Gosford Hospital, Peter MacCallum Cancer Centre, Westmead Hospital, Albury Wodonga Regional Cancer Centre, Integrated Clinical Oncology Network, Concord Repatriation General Hospital, Austin Health, Sir Charles Gardiner Hospital, Townsville Hospital, St Vincent's Hospital (Sydney), Prince of Wales Hospital, Barwon Health, Calvary Mater Hospital, Orange Health Service, Canberra Hospital, Royal Melbourne Hospital, Box Hill Hospital, Monash Health Service.

This is a randomised, multi-arm study platform to compare the efficacy of experimental therapies versus standard of care in patients with acute myeloid leukaemia in first complete remission. The International AML Platform Consortium (IAPC) is an adaptive trial platform designed to flexibly and efficiently compare the efficacy of novel therapies or combinations to the current standard of care.

Medical Oncology

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Aghmesheh M, Chantrill L, Brungs D, Clingan P, Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Locally Advanced Rectal Cancer: A Multicentre Randomised Study (DYNAMIC-Rectal).
Locations: Wollongong Hospital.

The main objective of this study is to demonstrate that an adjuvant therapy strategy incorporating ctDNA results in addition to standard pathologic risk assessment will reduce the number of patients receiving adjuvant chemotherapy compared to standard of care.

 

Antill Y, Stockler M, York S, Glasgow A, Chantrill L, Mapagu C, Robinson S, Leighton C, Phase III double-blind randomized placebo controlled trial of Atezolizumab in combination with Paclitaxel and Carboplatin in women with advanced/recurrent endometrial cancer (Atezolizumab Trial in Endometrial cancer - AtTEnd).
Locations: Wollongong Hospital.
External Partners: Frankston Hospital, NHMRC Clinical Trials Centre, University of Sydney.

This study will evaluate the efficacy in terms of progressive free survival and overall survival of first-line atezolizumab versus placebo in combination with carboplatin and paclitaxel in patients with advanced stage III/IV or recurrent endometrial cancer.

 

Azad A, Zhang D, Brungs D, Glasgow A, Leighton C, Robinson S, A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Prostate Cancer (XL184-315).
Locations: Wollongong Hospital.
External Partners: Peter MacCallum Cancer Centre, Box Hill Hospital, Frankston Hospital, Ballarat Base Hospital, Royal Adelaide Hospital, Canberra Hospital.

The purpose of this study is to find out whether cabozantinib in combination with atezolizumab is effective in treating metastatic castration-resistant prostate cancer compared with a second Novel Hormonal Therapy. The novel hormonal therapies (NHT) used in the study are abiraterone and enzalutamide. 

 

Brungs D, First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy.
Locations: Wollongong Hospital.

This is an observational retrospective review of Medical records of patients previously treated as part of their standard of care with Durvalumab.

 

Brungs D, Bajaj P, Fox W, Chantrill L, Aghmesheh M, Clingan P, Leighton C, Robinson S, (ARC-7)- A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination with AB122, and AB154 in Combination with AB122 and AB928 in Front-Line, Non-Cell Lung Cancer.
Locations: Shoalhaven District Memorial Hospital.
External Partners: The Tweed Hospital, Mid North Coast Cancer Institute.

 

Brungs D, Shinkel T, Chantrill L, Clingan P, Leighton C, Robinson S, Singh S, Yeo N, A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with Durvalumab, for the First-Line Treatment of Patients with Extensive Stage Small-Cell Lung Cancer (TAZMAN).
Locations: Wollongong Hospital.
External Partners: St Vincent's Hospital Melbourne.

Small-cell lung cancer can grow and spread quickly, and is one of two main types of lung cancer. It is normally treated with platinum-based chemotherapy, followed by Durvalumab. Platinum-based chemotherapy is a cancer treatment that uses a platinum metal based compound to attach to the DNA in the cancer cell, blocking the cell's ability to read the code, causing the cancer cell to die. Durvalumab is another anti-cancer drug that targets cancer cells by blocking the signals that stops the immune system from finding the cancer cell, allowing your immune system to fight and kill the cancer cells. AZD2811 is an investigational drug that will be used alongside Durvalumab. AZD2811 is an Aurora B Kinase inhibitor and stop the process of cell division. The aurora kinases are potential targets for anticancer therapy.

 

Brungs D, Yeo NKS, Immunotherapy (PD-1 inhibition) for advanced cutaneous squamous cell carcinoma: A retrospective review.
Locations: Wollongong Hospital.

Not all patients with SCC respond to immunotherapy. As clinical trials shift to earlier administration of immunotherapy in patients' treatment paradigms, there is an urgent need to identify biomarkers which predict response to immunotherapy. This project therefore aims to assess the responses to treatment with PD-1 inhibition in patients who have advanced SCC, and also to assess the influence of patient and tumour factors in determining responses to PD-1 inhibition

 

Burge M, Karikios D, Brungs D, Chantrill L, Clingan P, Aghmesheh M, Downton T, Bennett T, Singh S, Downton K, Yeo N, Leighton C, Robinson S, A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) plus Pembrolizumab (MK-3475) plus Chemotherapy Compared with Standard of Care Therapy as First-line Intervention in Participants with Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015).
Locations: Wollongong Hospital.
External Partners: Royal Brisbane and Women's Hospital, Nepean Hospital.

This study will include male and female participants with previously untreated, locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma who are ≥ 18 years.

 

Chantrill L, Siu H, O'Neill S, Diakos C, Tjokrowidjaja A, Abdelmogod A, De Silva M, Retrospective analysis of the tumor molecular profile and survival outcomes in young adults with early onset colorectal cancer (EO-CRC) in NSW, Australia.
Locations: Illawarra Shoalhaven Local Health District.
External Partners: Prince of Wales Hospital, University of Sydney, St George Hospital, Sutherland Hospital, Royal North Shore Hospital.

This project aims to describe the tumor molecular profile of young adults (age 18-49) diagnosed with colorectal cancer, identify risk factors including family history associated with early-onset CRC diagnosis, and study the survival outcomes of young adults diagnosed and received treatments in NSW, Australia.

 

Chantrill L, Aghmesheh M, Brungs D, Astellas: A Phase 2, Open-Label, Randomized Study to Assess the Antitumor Activity and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma.
Locations: Wollongong Hospital.

The purpose of this study is to assess the safety and antitumour activity of zolbetuximab in subjects with metastatic pancreatic adenocarcinoma whose tumours express CLDN18.2 (in >75% of tumour cells).  Zolbetuximab will be given in combination with Nab-paclitaxel and gemcitabine.  The study aims to determine overall survival and assess the safety and tolerability of the combination treatment. The study will also evaluate other anti-tumour effects, tumour markers and pharmacokinetics (PK) of zolbetuximab, NAb-P and GEM.

 

Chantrill L, Leighton C, Aghmesheh M, Brungs D, Clingan P, Robinson S, MoST PORCUPINE2: A Modular, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients with Advanced Solid Tumours that have Progressed following Therapy with Current Standard of Care.
Locations: Wollongong Hospital.

This study will assess the anti-cancer activity of RXC004 in participants with advanced solid cancers (at this time, this includes biliary tract cancer or pancreatic cancer) whose cancer has worsened following therapy with current standard of care. Furthermore, this study will assess the pharmacokinetics, safety, and tolerability of RXC004. Lastly, the study will explore potential biomarkers – these are molecules (for example, certain proteins) in the human body which can be tested to tell if people suffer from certain diseases and how they may respond differently to medication. These biomarkers may correlate with response to therapy and/or may be indicative of the effects of RXC004 on the body (called pharmacodynamics). The study will also explore the effect of RXC004 on patients' cancer using FDG-PET (F-deoxyglucose positron emission tomography) scans. 

 

Gibbs P, Solomon B, Pavlakis N, Kao S, Roberts-Thomson R, Nott L, Hughes B, Leong D, Millward M, Brungs D, Yeo N, Prevalence and clinical outcomes of KRASG12C mutated advanced lung cancer patients in Australia.
Locations: Wollongong Hospital.
External Partners: Walter and Eliza Hall Institute of Medical Research, Peter MacCallum Cancer Centre, Royal North Shore Hospital, Chris O'Brien Lifehouse, The Queen Elizabeth Hospital, Royal Hobart Hospital, Royal Brisbane and Women's Hospital, Canberra Hospital, Sir Charles Gardiner Hospital.

This is a retrospective cohort study of advanced KRAS G12C mutated non small cell lung cancer (NSCLC) patients diagnosed and treated in Australian cancer therapy centres. The primary objectives of this study are to determine the prevalence of KRASG12C mutated advanced NSCLC patients at Australian centres, describe the clinicopathological characteristics, real world treatment and outcomes of KRASG12C mutated advanced NSCLC and assess real world treatment and outcomes in KRASG12C mutated advanced NSCLC. Information obtained from this study will inform further study design and interpretation, including the potential real-world impact of a drug that is active in this patient population.

 

Khasraw M, Simes J, Wilson K, Wong SF, Lipton L, Price T, Markman B, Nott L, Michael M, Nagrial A, Chantrill L, Brungs D, Aghmesheh M, Leighton C, Robinson S, NABNEC: A Randomised Phase II Study Of nab-paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas.
Locations: Wollongong Hospital.
External Partners: Royal North Shore Hospital, University of Sydney, NHMRC Clinical Trials Centre, University Hospital Geelong, Royal Melbourne Hospital, The Queen Elizabeth Hospital, Monash Medical Centre, Royal Hobart Hospital, Peter MacCallum Cancer Centre, Westmead Hospital.

The aim of this project is to establish if carboplatin and nab-paclitaxel combination is an effective and tolerable chemotherapy treatment for grade 3 advanced gastrointestinal Neuroendocrine carcinomas (NECs), and to explore translational biologic, molecular and functional imaging endpoints to inform future research and improve outcomes for NEC patients.

 

Lindeman G, Aghmesheh M, Brungs D, Glasgow A, BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre, International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline Mutation.
Locations: Wollongong Hospital.
External Partners: Royal Melbourne Hospital, Peter MacCallum Cancer Centre, Walter and Eliza Hall Institute of Medical Research.

BRCA-P is an investigator initiated, phase III prevention trial for women with BRCA1 germline mutation, which increases lifetime risk of developing breast and ovarian cancers. The study will evaluate the role of denosumab in reducing breast cancer risk.

 

Prawira A, Aghmesheh M, Lim A, Ladwa R, Hart C, Brungs D, Leighton C, Robinson S, A randomized, double-blind placebo-controlled, Phase 3 study of Debio 1143 in combination with  platinum-based chemotherapy and standard fractionation intensity modulated radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy (TrilynX).
Locations: Wollongong Hospital.
External Partners: St Vincent's Hospital Sydney, Peter MacCallum Cancer Centre, Princess Alexandra Hospital, St Vincent's Hospital Melbourne.

The study drug Debio 1143 is being assessed to see if it can improve treatment outcomes for participants with locally advanced squamous cell carcinoma of the head and neck when used in combination with platinum-based chemotherapy and radiotherapy. The main purpose of this study is to learn how well the study drug works and how safe the study medicine is compared with placebo. 

 

Roy A, Mead K, Bright T, Karapetis C, Price T, Connel C, Burge M, Chantrill L, Singhal N, Robinson S, Leighton C, Brungs D, Aghmesheh M, Neoadjuvant Immune-Chemo-Radiotherapy in operable oEsophageal and gastro-oesophageal junction cancers with Carboplatin Paclitaxel Radiotherapy and Avelumab - a Trial assessing feasibility and preliminary Efficacy (NEOCREATE).
Locations: Wollongong Hospital.
External Partners: Central Adelaide Local Health Network, Flinders Medical Centre, The Queen Elizabeth Hospital, Adelaide Radiotherapy, Royal Brisbane Hospital, Royal Adelaide Hospital, Lyell McEwin Hospital.

A phase II study with safety run in to evaluate safety and preliminary efficacy of Avelumab in combination with chemotherapy plus radiotherapy in patients with resectable oesophageal/ gastro-oesophageal junction (GOJ) adenocarcinoma. This is a single arm study. Patients will receive  carboplatin/paclitaxel/radiotherapy, which is considered a standard of care treatment, with the addition of avelumab.  Patients will then proceed to surgery, which is also considered a standard treatment pathway for this patient population.

 

Vardy J, Clarke S, Karikos D, Chantrill L, Fox P, Dhillon H, Stockler M, Teng C, Park S, Blinman P, Brungs D, Aghmesheh M, Glasgow A, Mapagu M, Clingan P, Robinson S, Leighton C, Appadoo K, Yao N, Singh S, Bennett T, OXTOX: Can Oxaliplatin neurotoxicity be reduced with ibudilast in people with metastatic colorectal cancer - a phase II randomised study.
Locations: Wollongong Hospital.
External Partners: Concord Repatriation General Hospital, The University of Sydney, Northern Sydney Local Health District, Royal North Shore Hospital, Nepean Cancer Centre, Central West Cancer Care Centre, Concord Cancer Centre.

Oxaliplatin chemotherapy improves survival but causes acute neuropathy (pain on touching or swallowing cold objects or fluids, particularly) and chronic chemotherapy-induced peripheral neuropathy (CIPN) in almost everyone receiving it. This causes numbness, discomfort, and pain, especially in the hands and feet. CIPN can last for months to years after stopping treatment and significantly impacts quality of life and functional status. CIPN is the most common cause of patients needing a reduction in their oxaliplatin dose or having to stop oxaliplatin early. Currently there is no effective prevention or treatment, however animal studies have shown that taking ibudilast with oxaliplatin prevented symptoms of acute neurotoxicity and CIPN. This randomised phase II study evaluates whether ibudilast decreases the severity of acute neuropathy in humans and enables people with metastatic colorectal cancer to receive more oxaliplatin before needing dose modification for CIPN.

 

Zielinski R, Glasgow A, Brungs D, de Leon J, A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non Muscle Invasive Bladder Cancer Patients.
Locations: Wollongong Hospital.
External Partners: Orange Hospital.

This research is being conducted to find out if durvalumab combined with standard treatment Bacillus Calmette-Guerin (BCG) works and is safe in treatment of high risk non-muscle invasive bladder cancer.  In some patients’ cancer cells and immune cells start to express signals stopping the body’s immune system killing the cancer.  One signal is Programmed Cell Death Ligand 1 or PD-L1 for short.  Drugs like durvalumab work to block this signal and increase immune response.  Durvalumab is an antibody (protein produced by the body’s defence system) and it is hoped that by blocking this signal, the immune cells will once again be able to prevent or slow down cancer growth.

Radiation Oncology

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Aly F, Miller A, Holloway L, Field M, Estall V, Investigation of the accuracy and utility of existing prognostic models in an Australian cohort of patients with Head and Neck Squamous Cell Carcinoma.
Locations: Illawarra Cancer Care Centre.
External Partners: Liverpool and Macarthur Cancer Therapy Centres, Ingham Institute, University of New South Wales.

This study aims to determine the feasibility of using existing predictive models in an Australian cohort of patients with Head and Neck cancer, and to then externally validate existing predictive models in the study patient cohort.

 

Bell L, Brungs D, Chen J, Carolan M, Ahamed N, Causer T, Hundy M, Gandhidasan S, Splitt A, Jaeger M, Miller A, Trinh H, Crinnion C, Determining Early Treatment Response: Maximising Multi-parametric MRI use for brain cancer patients.
Locations: Wollongong Hospital.

Currently employed radiology techniques at Illawarra Shoalhaven Local Health District (ISLHD) don't adequately differentiate treatment response from pseudoprogression (PsP) in high-grade (WHO Grade 3 & 4) primary brain tumours. Multi-Parametric MRI (mpMRI) data, coupled with tumour molecular features, will facilitate more informed treatment decisions for these patients and enable earlier interventions. This single centre, prospective, longitudinal study aims to correlate mpMRI radiomic features and tumour molecular features with clinical outcomes to aid in the treatment response stratification of patients with high-grade brain tumours. 

 

Gafoor MAA, Miller A, Vijayakumar V, An external validation of the Candiolo Nomogram in a cohort of Australian patients treated with primary radiotherapy for prostate cancer.
Locations: Illawarra Shoalhaven Local Health District.

This study aims to perform an external validation for the Candiolo nomogram, an algorithm designed to predict prostate cancer recurrence in patients treated with radiotherapy, using data from an Australian institution.

 

Grierson E, de Leon J, Wilkinson D, Bell L, Dosimetric impact of uniform versus differential prostate bed expansion margins in post-prostatectomy prostate cancer patients utilising image-guided radiotherapy (IGRT).
Locations: Wollongong Hospital.

The aim of this study is to determine the optimal PTV margin for adequate CTV dose, while minimising the dose received by the rectum and bladder during an entire radiotherapy course. Bony match will be compared to clip match to determine the preferred image guidance policy.

 

Grierson E, Trinh H, Miller A, Chen HMN, Outcomes of Merkel Cell Carcinoma from a single institution.
Locations: Wollongong Hospital.

Merkel cell carcinoma (MCC) is a rare, cutaneous neuroendocrine cancer. Using the existing ISLHD cancer services database, this project will provide demographic and tumour related covariate insights, assessing patient characteristics, treatment received, plus recurrence and survival.

 

Miller AA, Ahmad I, Predicting pathological response to neo-adjuvant chemoradiotherapy in oesophageal cancer using Engineered Features and Deep Learning models.
Locations: Wollongong Hospital.
External Partners: Rajiv Ghandi Cancer Centre (New Delhi, India), Keele University (United Kingdom).

The area of Radiomics is in its infancy. It is clear that data sets are not large enough for robust analysis. It is also unclear whether existing studies are based on complete routine clinical datasets. The ICCC data of 60 patients will be used as a validation data set for the RGCC data of 192 patients. This combined data set is the largest available. It is also unusual in coming from two disparate sources. It is unknown whether oesophagus cancer in India looks and behaves the same as in Australia. Clinically, this study aims to identify patients who achieve complete pathological response to chemoradiation, and can be spared oesophagectomy.

 

Miller AA, Schumacher M, RadScore001: Validation a radiomics-based Rad Score predicting Lymph Node positivity in Stage I-II Non-Small Cell Lung Cancer.
Locations: Wollongong Hospital.

This study aims to test the validity of the Lymph Node Rad Score against the non-contrast planning CTs o a cohort of State I/II patients from the Illawarra Cancer Care Centre

 

Schutze H, Sandell T, Miller A, Shared-care cancer follow-up with general practitioners and radiation oncologists.
Locations: Wollongong Hospital, Shoalhaven District Memorial Hospital.
External Partners: University of Wollongong.

This research explores a shared care model of follow-up care for breast, colorectal and prostate cancer patients that have been treated with radiotherapy. This research will involve general practitioners performing some of the routine radiotherapy follow-up visits, whilst ensuring the patient’s care continues to be overseen by the radiation oncologist. 

 

Smee R, Wratten C, Miller A, Fowler A, Graham P, Eade T, Milross C, O'Connor C, Kotevski D, Vajdic C, Field M, Masters K, Using machine learning to understand and improve care and outcomes for head and neck cancer patients.
Locations: Wollongong Hospital, Shoalhaven District Memorial Hospital.
External Partners: Prince of Wales Hospital, Prince of Wales Private Hospital, Sydney Children's Hospital, Tamworth Base Hospital, University of New South Wales, Calvary Mater Newcastle, University of Newcastle, University of Wollongong, Liverpool Hospital, Campbelltown Hospital, St George Hospital, Royal North Shore Hospital, University of Sydney, Chris O'Brien Lifehouse, Macquarie University Hospital, Macquarie University, Ingham Institute for Applied Medical Research.

This project aims to extract public and private hospital electronic data from two cancer services information systems (Mosaiq and Aria) about NSW residents who have been diagnosed with head and neck cancer (HNC) at participating NSW Cancer Centres.  Anonymised demographic, clinical, histopathological, treatment and outcomes data will be extracted using structured query language and natural language processing.  Machine learning techniques will be used to predict well-established outcomes (local control, ultimate local control, overall survival, and cancer-specific survival) in HNC patients (nasopharynx, oral cavity, oropharynx, hypopharynx, and larynx). This research aims to help drive improvements in policy and practice to improve care and outcomes for HNC patients.

 

Stockler M, Roncolato F, Bracken K, Gandhidasan S, Nasser E, Miller A, Leighton C, Robinson S, DASL-HiCaP: Darolutamide Augments Standard Therapy for Localized High-Risk Cancer of the Prostate (ANZUP1801). A randomized phase 3 trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in high risk, clinically localized prostate cancer.
Locations: Wollongong Hospital, Shoalhaven District Memorial Hospital.
External Partners: NHMRC Clinical Trials Centre, Macarthur Cancer Therapy Centre.

The purpose of this study is to determine if adding darolutamide to standard care can improve outcomes for patients with prostate cancer that is going to be treated with radiation and hormone therapy. This is because these patients have prostate cancer that has features suggesting that its risk of recurrence is higher than average. The primary objective of the study is to determine the effect of adding darolutamide to standard care on survival without the spread of prostate cancer to other parts of the body.

Cancer Genetics

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Forrest L, James P, Keogh L, Duffy J, The psychosocial implications of managing significantly increased risks of breast and ovarian cancer during young adulthood: A national survey of young women who have had genetic testing for a BRCA1/2 mutation.
Locations: Wollongong Hospital.
External Partners: Peter MacCullum Cancer Centre, Royal Melbourne Hospital, University of Melbourne.

This protocol describes a mixed methods study consisting of two stages to develop and then conduct a national online survey with young women aged 18-40 years with a BRCA1/2 mutation. The qualitative results of a previous study illuminated the need to expand the data collection to a national population of young Australian women to fully examine the psychosocial complexities of living with a BRCA1/2 mutation. Therefore, this component of research uses an online survey to enable recruitment and data collection nationally, through all Australian genetic services and familial cancer centres. The aim of this component is to examine the psychosocial implications of managing significantly increased risks of breast and ovarian cancer during young adulthood experienced by Australian women with a BRCA1/2 mutation.

 

Gonzalez T, Williams R, Duffy J, Zia R, Tucker K, Taylor N, Wakefield C, De Abreu Lourenco R, Warwick L, CONsultation via Telehealth to Access Cancer geneTic counselling (CONTACT).
Locations: Wollongong Hospital.
External Partners: Prince of Wales Hospital, ACT Genetic Service, St George Hospital, University of New South Wales, Cancer Council NSW, Sydney Children's Hospital, University of Technology Sydney.

The CONTACT study is trialling the use of direct-to-patient Telehealth in cancer genetic counselling. This study aims to demonstrate the non-inferiority of Telehealth compared to standard care (telephone and face-to-face appointments), assess patient and genetic counsellor acceptability and satisfaction with the technology and determine the costs and implementation challenges associated with Telehealth.  

 

Joseland S, Andrews L, Greening S, ANGELS - Applying Novel Genomic approaches to Early-onset and suspected Lynch Syndrome colorectal and endometrial cancers.
Locations: Wollongong Hospital.
External Partners: South Eastern Sydney Local Health District, University of Melbourne.

The ANGELS study recruits patients with suspected Lynch syndrome, early onset colorectal and endometrial cancer, with no known genetic cause. Tumour tissue will be tested for somatic mutations in the mismatch repair genes and the blood-derived DNA will be tested for novel genetic mutations not clinically tested and germline mutations in other DNA repair genes. The research will investigate potential flaws in current testing methods for Lynch Syndrome that may be missing gene mutations or alternatively different mechanisms other than Lynch syndrome that result in cancers with mismatch repair deficiency or early-onset.

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