Western Health Cancer Services (medical oncology, haematology and palliative care) serves patients across the Western Health sites, including Sunshine, Footscray, Melton and Sunbury.

The department has a strong, collaborative partnership with the Peter Mac Radiation Oncology service based on the grounds of Sunshine Hospital.

The Western Health Cancer Clinical Trials Unit (WHCCTU) has been an integral part of this department since 1996. With a research team of over 25 medical specialists and 15 nurses and study coordinators, the unit staff have a wealth of experience from conducting over 400 clinical trials in the areas of oncology, haematology, radiation oncology and supportive palliative care.

WHCCTU actively participates in commercial sponsored clinical trials for Western Health and multiple health services across Australia and the world. The Unit also has strong ties with collaborative groups, such as Breast Cancer Trials Australia, Australasian Leukaemia and Lymphoma Group (ALLG) and the VCCC Alliance and is an active participant. The types of trial conducted by the WHCCTU range from early phase (1B) trials to data collection registries for further research on diseases such as lymphoma and myeloma.

Current active clinical trials:

Haematology (Blood)

SeaLAND: Low dose Selinexor and Lenalidomide post ASCT for Newly diagnosed multiple myeloma (SeaLAND study) Collaborative Sponsor:  ALLG Principal Investigator: William Renwick

Frail M: Frailty-stratified, randomised controlled bayesian adaptive trial of bortezomib v’s lenalidomide in transplant ineligible myeloma (TI-NDMM) – the FRAIL-M study Collaborative Sponsor: ALLG Principal Investigator Sophie Lee

PETReA: PETReA: Phase 3 evaluation of PET-guided, Response-Adapted therapy in pts with previously untreated, high tumour burden follicuar lymphoma Collaborative Sponsor: ALLG Principal Investigator Duncan Carradice

CATER-HL HD12: An ALLG phase 2 study of CHOP and Tislelizumab in EldeRly pts with Hodgkin Lymphoma Collaborative Sponsor: ALLG       Principal Investigator:  William Renwick

RADAR HD13: A randomised Phase 3 trial with a PET response adapted design comparing ABVD +/- ISRT with A2VD +/- ISRT in patients with previously untreated stage IA/ IIA Hodgkin lymphoma Collaborative Sponsor: ALLG Principal Investigator: Michael Gilbertson

LOXO_BTK200300: A phase 3 open-label, randomized study of pirtobrutinib (LOXO-305) v’s ibrutinib in pts with chronic lymphocytic leukemia/ small lymphocytic lymphoma       Commercial sponsor: LOXO oncology Principal Investigator:      William Renwick

MK4280A-008: Phase 3 Randomised Clinical Study of MK4280A (coformulated favezelimab (MK4280) plus pembrolizumab (MK3475)) v’s physician’s choice Chemotherapy in PD-1/L1-refractory relapsed or recurrent classical Hodgkin Lymphoma Commercial sponsor: MSD/ Merck Principal Investigator: Michael Gilbertson

MK1026-010 BELLWAVE-010: A randomised study to compare the efficacy and safety of nemtabrutnib (MK1026) plus venetoclax v’s venetoclax plus rituximab in participants with relapsed/ refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma following at least 1 prior therapy – BELLWAVE-010 Commercial sponsor: MSD/ Merck Principal Investigator: Michael Gilbertson

MK3543-006: Phase 3 Multi-centre, randomized, controlled study to assess the safety and efficacy of Bomedemstat (IMG-7289) v’s best available therapy (BAT) in pts with essential thrombocythemia who are resistant to or intolerant of hydroxyurea Commercial sponsor: MSD/ Merck Principal Investigator: William Renwick

Rationalise: A randomised Controlled trial continuing immunoglobulin therapy, or stopping with or without prophylactic antibiotics, on infection rate in pts with acquired hypogammagloulinmia secondary to haematological malignancies Collaborative Sponsor: Monash Principal Investigator Michael Gilbertson

Breast

Kat6 (C4551001): Phase 1 clinical study for pts  with ER+/HER2- Breast Ca. The primary objective of the C4551001 study is to establish a dosage of IP with combination Txs (i.e. Part1 B -IP with either fulvestrant & Part 1C -IP with Letrozole + palbociclib). Part 2 is a dose Expansion, monotherapy (2A) & combination (2B) in ER+/HER2- breast Ca with the potential to expand into other solid tumors. Commercial sponsor: Pfizer Principal Investigator:Cath Oakman

DECRESCENDO: De-Escalation of Adjuvant chemotherapy in HER2-Positive, estrogen receptor-negative, node-negative earlybreast cancer subjects who achieved pathological complete response after neoadjuvant chemotherapy and dual HER2 blockade Collaborative Sponsor: Breast Inter Group Principal Investigator: Cath Oakman

TUGETHER: A phase II, two-arm, non-comparative, multicentre study of tucatinib (ONT-380), pembrolizumab (MK-3475) and trastuzumab in pts with pre-treated advanced HER2-positive breast cancer Collaborative Sponsor: BreastCancerTrials  Principal Investigator:Cath Oakman

CO44194: A Phase II, multicentre, randomised, double-blind study of RO7247669 combined with nab-paclitaxel compared with pembrolizumab combined with nab-paclitaxel in participants with previously untreated, PD-L1 positive, locally-advanced unresctable or metastatic triple-negative breast cancer Commercial sponsor: Roche Principal Investigator: Caitlin Murphy

OPTIMA: Optimal Personalised Treatment of early breast cancer using Multi- parameter Analysis Collaborative Sponsor: BreastCancerTrials  Principal Investigator:Chrissy Muttiah

ASCENT 7: A phase 3 study of sacituzumab govitecan v’s treatment of physician’s choice in pts with hormone receptor- positive (HR+)/ human epidermal growth factor receptor 2- negative (HER-2) (HER2 IHC0) or HER2-low (IHC1+, IHC2+/ISH_) inoperable, locally advanced or metastatic breast cancer and have received endocrine therapy Commercial sponsor: Gilead Principal Investigator:Cath Oakman

Lung

PACIFIC-9: Phase III, Double-Blind, Placebo-Controlled, Randomized Multicentre, International Study to determine the efficacy of Durvalumab plus Oleclumab (CD73) and Durvalumab plus Monalizumab (NKG2A) in patients with locally advanced (stage III), unresectable non-small cell lung cancer (NSCLC) who have not progressed following definitive, platinum-based concurrent chemoradiation therapy. Commercial sponsor: AstraZeneca Principal Investigator: Suzanna Kosmider

BGB 900-102: Phase 1-2 Study Investigating Safety, Tolerability, Pharacokinetics and Preliminary Antitumour activity of Anti-TIM-3 Monoclonal antibody BGB-A425 in combination with Anti-PD-1 Monoclonal antibody tislelizumab in patients with advanced solid tumours Commercial sponsor: BeiGene Principal Investigator: Suzanna Kosmider

AK104-212: A Phase 2 study for pts with extensive stage small cell lung cancer who failed 1L therapy. The study will explore a combination treatment of AK104 infusion (PD-1/ CTLA-4 blocker Mab) with Chiauranib, an AURKB, CSF1R and VEGFR/PDGFR/c-Kit inhibitor (Daily Capsules), which has shown promising efficacy results in phase II trial Commercial sponsor: Akesobio  Principal Investigator: Suzanna Kosmider

DREAM3R: DuRvalumab (MEDI4736) with chEmotherapy as first line treAtment in advanced pleural Mesothelioma – A phase 3 Randomised trial Collaborative Sponsor: NHMRC CTC      Principal Investigator: Suzanna Kosmider

Upper Gastrointestinal/ Liver (Stomach, intestine, liver)

AMP-945: Phase 1b/2a, Multientre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in combination with Nab-Paclitaxel and Gemcitabine in Pancreatic cancer patients Commercial sponsor: Amplia Principal Investigator: Lara Lipton

ARTEMIDE : A Phase III, randomised, double-blind, placebo-controlled, mulitcentre, global study of rilvegostomig in combination with chemotherapy as adjuvant treatment after resection for biliary tract cancer with curative intent  Commercial sponsor: AstraZeneca Principal Investigator: Michael Lam

Colorectal (Large intestine)

STELLAR-303: A Randomized Open-Label Phase 3 Study of XL092 and atezolizumab v’s regorafenib in subjects with metastatic colorectal cancer Commercial sponsor: Exelixis Principal Investigator: Peter Gibbs

Genitourinary (Bladder, kidneys, genitals)

JAVELIN BLADDER MEDLEY: Phase 2 multicenter, randomized, open label, parallel-arm, umbrella study of I.P. in combination with other anti-tumour agents as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma  whose disease did not progress with first line platinum-containing chemotherapy. Commercial sponsor: MSD/ Merck Principal Investigator: Shirley Wong

STELLAR- 304: A randomised open-label Phase 3 study of XL092 + nivolumab v’s sunitinib in subjects with advanced or metastatic non-clear cell renal cell carcinoma. Commercial sponsor: Exelixis  Principal Investigator: Shirley Wong

Other

IMPARP-HRD: An open label, signal seeking, transational Phase 2 trial of Pamiparib in Combination with Tislelizumab in Patients With Advanced Tumours with Homologous Recombination Repair Defects Commercial sponsor: BeiGene Principal Investigator: Keri-Lee Geneser

Radiation Oncology

PRIME_Lung: Primary Radiotherapy in Metastatic Lung Cancer. A pilot study Collaborative Sponsor: PeterMac  Principal Investigator: Fiona Hegi-Johnson

DECREASE: DarolutamidE + Consolidation RadiothErapy in Advanced proStatE cancer detected by PSMA Collaborative Sponsor: TROG  Principal Investigator:Tristan Molde-Hauer

DIPPER: A multicentre, randomised phase 2 clinical trial of early salvage radiotherapy versus surveillance for biochemical recurrence after radicalprostatectomyincorporating clinical and imaging-based risk stratification Collaborative Sponsor: PeterMac  Principal Investigator:Tristan Molde-Hauer

POPSTAR-2: Lu-PSMA for Oligometastatic Prostate Cancer Treated with Stereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial Collaborative Sponsor: PeterMac  Principal Investigator:Tristan Molde-Hauer

Page last updated March 2024