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 1993. With a strong research team of medical specialists, research 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 on a local and global scale. The Unit also has strong ties with collaborative groups, such as Breast Cancer Trials Australia (BCT), Australasian Leukaemia and Lymphoma Group (ALLG), Australasian Myeloma Research Consortium (AMaRC), Walter and Eliza Hall institute (WEHI), Australasian Gastro-intestinal Trials Group (AGITG), Australian New Zealand Gynaecological Oncology Group (ANZGOG) and the VCCC Alliance. 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.
Cancer Services Research Unit_advertising brochure_Mar25
Current active clinical trials:
Breast
BGB-21447-102: A phase 1 study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumour activity of BGB-21447 (a Bcl-2 inhibitor) combinations for pts with HR+/ HER2- metastatic breast cancer. Commercial sponsor: BeiGene Principal Investigator: Dr Christine Muttiah
DYNASTY-BREAST02: A phase 3, randomized, multi-centre, open-label study of DB-1303 v’s Investigator’s choice chemotherapy in human epidermal growth factor receptor 2 (HER2)-low, hormone receptor positive (HR+) metastatic breast cancer pts whose disease has progressed on endocrine therapy (ET). Commercial Sponsor: Duality Principal Investigator: Dr Catherine Oakman
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: Dr Catherine Oakman
OPTIMA: Optimal Personalised Treatment of early breast cancer using Multi- parameter Analysis. Collaborative Sponsor: BreastCancerTrials Principal Investigator: Dr Christine Muttiah
pionERA: Phase 3, Open Label study evaluating efficacy and safety of giredestrant compared to fulvestrant, both in combination with choice of CDK 4/6i in ER+, HER2- advanced breast cancer with secondary resistance to prior adjuvant Treatment. Commercial Sponsor: Roche Principal Investigator: Dr Catherine Oakman
ZN-A-1041: A phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ZN-A-1041 enteric capsules as a single agent or in combination in pts with HER2-positive advanced solid tumours. Commercial Sponsor: Roche Principal Investigator: Dr Catherine Oakman
Colorectal
ALT-TRACC: Alternating oxaliplatin and irinotecan doublet schedules v’s continuous doublet chemotherapy in previously untreated metastatic colorectal cancer: a treatment or recurrent and advanced colorectal cancer registry-based prospective randomised trial (ALT-TRACC). Collaborative Sponsor: WEHI Principal Investigator: Dr Vanessa Wong
BIOMARCER-2: Biomarker informed optimal management of advanced RAS wild type colorectal cancer. Collaborative Sponsor: WEHI Principal Investigator: Dr Shehara Mendis
FORECAST-2: Feasibility of using Organoid Response to inform treatments for patients with colorectal cancer, starting first-line therapy. Collaborative Sponsor: WEHI Principal Investigator: Dr Shehara Mendis
ORIGAMI-3: A randomised, open-label, phase 3 study of amivantamab + FOLFIRI v’s Cetuximab/ Bevacizumab + FOLFIRI in pts with KRAS/ NRAS and BRAF wild-type recurrent, unresectable or metastatic colorectal cancer who have received prior chemotherapy. Commercial Sponsor: WEHI Principal Investigator: Prof Peter Gibbs
RESOLUTE: Randomised Phase II trial to evaluate the strategy of integrating local ablative therapy with first-line systemic treatment for unresectable oligometastatic colorectal cancer. Collaborative Sponsor: Peter MacCallum Cancer Centre Principal Investigator: Dr Jeanne Tie
Colorectal and Upper Gastrointestinal/ Liver
CP-IVX001: A phase 1 open-label, non-randomised, multi-cohort clinical study of intratumoral IVX037 as monotherapy or in combination with an immune checkpoint inhibitor in patients with advanced or metastatic solid tumours. Commercial Sponsor: ImmVirX Pty Ltd Principal Investigator: Dr Shehara Mendis
Genitourinary
BO45230: A randomised, phase 2, double-blind, multicentre study of autogene cevumeran plus nivolumab v’s placebo plus nivolumab as adjuvant therapy in pts with high-risk muscle-invasive urothelial carcinoma. Commercial sponsor: Roche Principal Investigator: Dr Shirley Wong
9785-CL-0123: A phase 2, open-label extension study for participants with prostate cancer who previously participated in an enzulutamid clinical study. Commercial sponsor: Astellas Pharma Principal Investigator: Dr Shirley Wong
Gynaecology
KAB12952 BNT323-01: A phase 3, randomised, multi-site, open-label trial of BNT323/ DB-1303 v’s investigator’s choice of chemotherapy in previously treated pts with HER2- expressing recurrent endometrial cancer. Commercial Sponsor: BioNTech Principal Investigator: Dr Keri-Lee Geneser
Haematology
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: Dr Sophie Lee
IBIS: An immuno-therapeutic salvage strategy for ‘functional’ high-risk (FHR) multiple myeloma incorporating iberdomide, isatuximab and dexamethasone (IBIS). Collaborative Sponsor: AMaRC Principal Investigator: Dr Sophie Lee
GOLSEEKE-1: A phase III, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of CC-99282 (Golcadomide) plus R-CHOP chemotherapy versus placebo plus R-chop chemotherapy in subjects with previously untreated aggressive B-Cell lymphoma. Commercial sponsor: Bristol Myers Squibb Principal Investigator: Dr William Renwick
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: Dr 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: Dr 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: Dr Michael Gilbertson
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: Dr Michael Gilbertson
Lung
DS7300-188: A Phase 3, multicentre, randomised, open-label study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 antibody drug conjugate (ADC), v’s treatment of Physician’s choice (TPC) in pts with replapsed small cell lung cancer (SCLC) (Ideate-2) Commercial Sponsor: MSD/Merck Principal Investigator: Dr Suzanne Kosmider
MK2870: Randomised, open label, Phase 3 study of MK2870 v’s docetaxel in previously treated advanced or metastatic NSQ Non-small cell lung cancer with EGFR mutations or other genomic alterations Commercial Sponsor: Daiichi Sankyo Principal Investigator: Dr Suzanne Kosmider
NSCLC BNT327-06: A phase 2/ 3, multi-site, randomised study for a global trial of BNT327 in combination with chemotherapy and otherinvestigational agents in first-line non-small cell lung cancer (NSCLC). Commercial Sponsor: BioNTech Principal Investigator: Dr Suzanne Kosmider
SCLC BNT327-03: A phase 3, multi-site, double-blinded, randomised trial of BNT327 in combination with chemotherapy (etoposide/ carboplatin) compared to atezolizumab in combination with chemotherapy (etoposide/ carboplatin) in pts with first-line extensive-stage small-cell lung cancer. Commercial sponsor: BioNTech Principal Investigator: Dr Suzanne Kosmider
SPLFIO-174: A phase 1b/2, multicentre, open-label platform study of select immunotherapy combinations in adult participants with previously untreated advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression Commercial Sponsor: Servier Principal Investigator: Dr Azim Jalali
Lung and Genitourinary
CP-AU-007: A Phase 1/2 First in Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody that Binds to IL-2 and Inhibits IL-2Ra Binding, in Patients with Unresectable Locally Advanced or Metastatic Cancer. Commercial Sponsor: Aulos Bioscience Principal Investigator: Dr Catherine Oakman
Upper Gastrointestinal/ Liver
NeoFOL-R: Efficacy of Neoadjuvant FOLFIRINOX in resectable pancreatic cancer: An international, multi-centre, randomised, controlled trial (NeoFOL-R). Collaborative sponsor: Epworth HealthCare Principal Investigator: A/Prof Lara Lipton
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: Dr Keri-Lee Geneser
Radiation Oncology
POPSTAR: Lu-PSMA for Oligometastatic Prostate Cancer Treated with Stereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial. Collaborative Sponsor: PMCC Principal Investigator: Dr Tristan Molder-Hauer
PRESERVE: Partial breast re-irradiation using ultra hypopractionation (PRESERVE) Phase 2 multi-institutional study. Collaborative Sponsor: TROG Principal Investigator: Dr Keelan Byrne
Page last updated July 2025
