Clinical Trials

Clinical trials test new treatments to find better ways to prevent, detect or treat disease. Both healthy people and people with a disease or condition can volunteer to be part of a trial.

Cancer Care Services participate in a range of clinical trials at our hospitals. For information about any of the trials below, ask your doctor or nurse.

For information about clinical trials in general visit the Australian Clinical Trials website or search the Australia and New Zealand Clinical Trials Registry.

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Disease	Trial name	Trial description	Hospital
Acute Leukaemia	ALLG NBCR	Australasian Leukaemia and Lymphoma Group National Blood Cancer Registry	RBWH
Breast	Pfizer C5731006	A phase 1b/2, open-label, multicohort study of Disitamab Vedotin in adults with HER2 expressing Advanced Breast Cancer	RBWH
Breast	PaxPlus-ABC (KZA-0084-ABC001)	A phase 1b, multi-centre, open-label, randomized study to evaluate the safety, tolerability, and clinical activity of combining paxalisib with olaparib or pembrolizumab/chemotherapy in patients with advanced breast cancer	RBWH
Breast	MK-2870-012	A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery	RBWH
Breast	TABITHA	Study of the clinical outcomes and analysis of anti-HER2 therapy in treatment of metastatic HER2 positive breast cancer	RBWH
CNS	AnHeart	AnHeart - A Phase 2, multicenter, clinical study to evaluate the efficacy and safety of safusidenib erbumine in patients with isocitrate dehydrogenase 1 (IDH1)-mutant glioma	RBWH
CNS	The ACTION Study (ONC201-108)	ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study	RBWH
CNS	LUMOS2	Low and Anaplastic Grade Glioma Umbrella Study of Molecular Guided Therapies: A phase 2, multi-centre, open-label, biomarker-directed, umbrella, clinical trial for recurrent IDH mutant, grade 2/3 glioma.	RBWH
CT - Haemophilia	Regeneron REGV131 LNP1265 BEYOND-9	A Phase 1/2 Open-label Study of REGV131 LNP1265, A CRISPR/Cas9-Based Coagulation Factor IX Gene Insertion Therapy in Participants with Hemophilia B	RBWH
CT - Haemophilia	Rare Factor Deficiencies & AT Knockdown	Evaluating the in vitro effect of antithrombin (AT) inhibition on thrombin generation in patients with severe Factor V, Factor VII or Factor XI deficiencies by AT-antibodies	RBWH
CT - Myeloma - MM	BMS CA088-1000 QUINTESSENTIAL	A Phase 2, Open-Label, Multicenter Study of Arlocabtagene Autoleucel (BMS 986393), a GPRC5D-directed CAR T Cell Therapy in Adult Participants with Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)	RBWH
Endometrial	GSK BEHOLD	A randomized, multicenter, open-label, Phase 3 study to evaluate GSK5733584 in comparison with chemotherapy in participants with recurrent endometrial cancer (BEHOLD-Endometrial01)	RBWH
Gastric	Gilead GS-US-742-7757 Gastric	Evaluate Denikitug as Monotherapy or in Combination with Nivolumab or Chemotherapy in Participants with HER2-negative, Unresectable, Recurrent, and/or Metastatic Gastric,Esophagogastric Junction (GEJ) and Esophageal Adenocarcinomas	RBWH
GBM	GBM AGILE	An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma	RBWH
GBM	FIG	Prospective, multicenter trial evaluating FET-PET in Glioblastoma	RBWH
Genito-Urinary	OMAHA-4 (MK-5684-004)	A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment with One Next-generation Hormonal Agent (NHA)	RBWH
Genito-Urinary	ePAD	Electronic Prostate Cancer Australian Database (ePAD): Analyzing Treatment Patterns and Outcomes from Real-World Patients with Advanced Prostate Cancer	RBWH
Genito-Urinary	iTestis	Bioinformatics for Testis Cancer	RBWH
Genito-Urinary	PREDICT-RCC	PREDICTing treatment response to first-line immunotherapy-based combinations with PSMA and FDG PET in advanced clear cell Renal Cell Carcinoma	RBWH
Genito-Urinary	TheraPb	Phase I Biodistribution and Dosimetry Study of Pb-ADVC001 in Metastatic Prostate Adenocarcinoma	RBWH
Genito-Urinary	BLADDA Project	Bladder and Urothelial Cancer Data- and Biobank	RBWH
Genito-Urinary	PSMAcTION (CAAA817A12201)	A phase II/III, open-label, international, multicenter, randomized study of AAA817 versus standard of care in the treatment of adult participants with PSMApositive metastatic castration-resistant prostate cancer who progressed on or after Lu-PSMA targeted therapy.	RBWH
Genito-Urinary	KRAB	Kidney canceR Australian registry and Biobank	RBWH
Genito-Urinary	P3BEP	A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for participants with intermediate and poor-risk advanced germ cell tumours.	RBWH
Gynaecological	MK-2870-033	A Phase 3 Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan in Combination with Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants with Mismatch Repair Proficient Endometrial Cancer (TroFuse-033)	RBWH
Gynaecological	ZOvCa	A phase 1 PET-CT study of⁸⁹Zr-hu/mo-10D7 in patients with advanced epithelial Ovarian Cancer	RBWH
Haem - Other	CARTey1 Phase 1 MB.CART19.1 CarT	Phase I Clinical Trial of MB.CART19.1 CD19 Chimeric Antigen Receptor (CAR) T Cells in Relapsed or Refractory CD19-Positive Haematological Malignancy	RBWH
Haemophilia	VEGA/STAR VGA039-CP002 VIVID-6	A Prospective, Multicenter, Open-label, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Prophylactic VGA039 in Adolescent and Adult Patients with von Willebrand Disease (VIVID-6)	RBWH
Haemophilia	CSL222_3005 IX-TEND	A Phase 3b, Open label, Multicenter, Single-dose Study Investigating Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy Administered to Adult Subjects with Severe or Moderately Severe Hemophilia B with Detectable Pretreatment AAV5 Neutralizing Antibodies	RBWH
Head and Neck	P2191	Development of an Adoptive T Cell Therapy for HPV-Associated Malignancies	RBWH
Head and Neck	OPC P16	A simple saliva test to diagnose head and neck cancer at an early stage - head and neck cancer detection is a spitting distance away	RBWH
Leukaemia	Geron MYF3001 Imetelstat in MF IMPACT	A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat (GRN163L) Versus Best Available Therapy (BAT) in Patients with Intermediate-2 or High-risk Myelofibrosis (MF) Refractory to Janus Kinase (JAK) Inhibitor	RBWH
Leukaemia - AML	ALLG AMLM26 INTERCEPT	Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Preemptive Therapy in AML): A Multi-arm, Precision-based, Recursive, Platform Trial Dr Steven	RBWH
Leukaemia - AML	ALLG AMLM30/HOVON-177 - EVOLVE II	Randomized study to assess revumenib in combination with azacitidine + venetoclax in adult patients with newly diagnosed NPM1-mutated or KMT2A-rearranged AML ineligible for intensive chemotherapy	RBWH
Leukaemia - AML	ALLG AMLM31/HOVON-181	Bleximenib or Placebo in Combination with Standard Induction and Consolidation Therapy followed by Maintenance for the Treatment of Patients with Newly Diagnosed KMT2A rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a double-blind phase 3 study	RBWH
Lower GI	RBWH & TPCH Colorectal Cancer Database	The Royal Brisbane and Prince Charles Hospital metastatic Colorectal Cancer database: A prospective observational cohort study examining clinical and molecular biomarkers	RBWH
Lower GI	BMS ROSETTA	A Randomized Phase 2/3 Study of BMS-986545 (BNT327) in combination with Chemotherapy Versus Bevacizumab in combination with Chemotherapy in Participants with Previously Untreated Unresectable, Recurrent, or Metastatic Colorectal Cancer	RBWH
Lower GI	TRACC	TRACC: Study of Clinical Outcomes and Analysis of Bevacizumab use in Metastatic Colorectal Cancer	RBWH
Lower GI	RBWH & TPCH Colorectal Cancer Database	The Royal Brisbane and Prince Charles Hospital metastatic Colorectal Cancer database: A prospective observational cohort study examining clinical and molecular biomarkers	NLH-COHD
Lower GI	RBWH & TPCH Colorectal Cancer Database	The Royal Brisbane and Prince Charles Hospital metastatic Colorectal Cancer database: A prospective observational cohort study examining clinical and molecular biomarkers	TPCH
Lung	ASPIRATION-2 Liquid	An observational cohort study to assess the impact of longitudinal molecular profiling using circulating tumour DNA (ctDNA) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) after failure of genomically targeted therapy	TPCH
Lung	AURORA	AUstralasian thoRacic cancers lOngitudinal cohoRt study and biobAnk	TPCH
Lung	OCEANiC	A phase 2, open-label, Multi-centre Clinical Trial of Osimertinib With or Without Adjuvant Chemotherapy Guided by Tumour NGS Co-mutation Status and ctDNA Detection in Patients With Stage 2A-3A EGFR-Mutant Non Small Cell Lung Cancer Following Complete Surgical Resection	TPCH
Lung	CA224-1093 NSCLC	A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy as First-line Treatment for Participants with Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and with Tumor Cell PD-L1 Expression ≥ 1%	TPCH
Lung	MK-1084-007 MSD KANDLELIT-007	MK-1084-007 MSD KANDLELIT-007A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)	TPCH
Lung	MK-2870-019	A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab with or without MK-2870 in Resectable Stage II to IIIB (N2) NSCLC for Participants not Achieving pCR after Receiving Neoadjuvant Pembrolizumab with Platinum based Doublet Chemotherapy Followed by Surgery	TPCH
Lung	CONVERGE	A Phase 2, randomized, open-label, active-controlled study of JNJ-90301900 in combination with chemoradiation followed by durvalumab in locally advanced and unresectable Stage III non-small cell lung cancer	RBWH
Lymphoma - Other	ALLG HD13 RADAR	A randomised phase III trial with a PET response adapted design ABVD +/- ISRT and A2VD +/- ISRT in patients with previously untreated stage IA/IIA Hodgkin lymphoma	RBWH
Lymphoma - Other	ALLG NHL37 GOLDiLOX	An open-label, single-arm, phase 2 trial of GlOfitamab anD pIrtobrutinib (LOXo-305) in patients with mantle cell lymphoma and prior exposure to a BTK inhibitor	RBWH
Lymphoma - Other	ALLG NHL34 Clarify	An ALLG National Platform Study for Identification and Early Intervention in Ultra-High-Risk Large B Cell Lymphoma	RBWH
Multi-Tumour Stream	Syneos 3BP-FO-004 (LuFOSTaR)	A Phase 1, Multicentre, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of FO-004 in Patients with Advanced Solid Tumours Theranostics	RBWH
Multi-Tumour Stream	INVITE	INVITE: In vitro testing of a novel immunotherapy for advanced cancer.	RBWH
Myeloma	Pfizer C1071032 MAGNETISMM	A Phase 3, Open-Label Study of Elranatamab Monotherapy Versus Elotuzumab, Pomalidomide, Dexamethasone (EPd) or Pomalidomide, Bortezomib	RBWH
NETs	Exelixis STELLAR	A phase 2/3, multicenter, randomized open-label study of zanzalintinib vs everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors	RBWH
NETs	AUS-NET	Implementing a Nurse-Enabled, Shared-Care Model to Address Unmet Needs of People with Neuroendocrine Tumours – a randomised-controlled type II hybrid effectiveness-implementation trial (the AUS-NET trial).	RBWH
NETs	PLANET Registry	An Observational, Multi-centre, Non-Interventional Programme to Register Patients Diagnosed With Neuroendocrine Neoplasms (NENs) and Monitor Their Patterns of Care in Australian Hospitals	RBWH
NETs	STOPNET	A randomised study of cessation of somatostatin analogues after Peptide Receptor Radionuclide Therapy in Mid, Hind-Gut and Pancreatic Neuroendocrine tumours	RBWH
Non CT - Leukaemia - MPN	Kartos Therapeutics KRT 232-115	A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib	RBWH
Oesophageal	PALEO	Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation	RBWH
Other	GeneScreen 5-FU	DPYD Genotype-guided dose Personalisation for Fluoropyrimidine prescribing in Cancer	RBWH
Other	SUPER-ED	Solving Unknown Primary cancER Earlier Diagnosis (SUPER-ED): A stepped wedge cluster randomised controlled trial implementing a Model of Care to support earlier diagnosis	RBWH
Other	GeneScreen 5-FU	DPYD Genotype-guided dose Personalisation for Fluoropyrimidine prescribing in Cancer	NLH-COHD
Other	GeneScreen 5-FU	DPYD Genotype-guided dose Personalisation for Fluoropyrimidine prescribing in Cancer	TPCH
Other	KEYNOTE-587	A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants who are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab	RBWH
Pancreas	PURPLE	Pancreatic cancer: Understanding Routine Practice and Lifting End results (PURPLE) Registry. A Prospective Pancreatic Cancer clinical registry.	RBWH
Prostate	Roche InavoPC CO45813	A phase II, randomized, multicenter, open-label study evaluating the efficacy and safety of the combination of inavolisib plus enzalutamide versus physician's choice of arpi or docetaxel in patients with metastatic castration-resistant prostate cancer.	RBWH
Prostate	NINJA	Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation	RBWH
Prostate	PSMA-DC	An International, Prospective, Open-label, Multi-centre, Randomized Phase III Study comparing lutetium (177Lu) vipivotide tetraxetan (AAA617) versus Observation to delay castration or disease recurrence in adult male patients with prostate-specific membrane antigen (PSMA) positive Oligometastatic Prostate Cancer (OMPC)	RBWH
Skin	DESQUAMATE	A phase 2 study of de-escalation in resectable, locally advanced cutaneous squamous cell carcinoma with the use of neoadjuvant Pembrolizumab	RBWH
Skin	I-MAT	MASC 03.18 I-MAT Trial - A randomised, placebo-controlled, phase II trial of adjuvant Avelumab in patients with stage I-III Merkel cell carcinoma	RBWH
Transplant	Novartis CCTL019A2205B - PAVO	Long term follow-up of patients exposed to Lentiviral-Based CD19 directed CAR T-Cell therapy	RBWH
Transplant	PACH-68	68Ga FAPI PET Assessment of Pulmonary Chronic Graft Versus Host Disease (PACH-68)	RBWH
Transplant	ANZHIT-2 SVHS	A multi-centre phase II, Australian and New Zealand, exploratory study of amendments to conditioning regimens in haplo-identical stem cell transplantation – The ANZHIT-2 study	RBWH
Transplant - aGVHD	MODULAATE – CSL964_2001	Phase 2/3, Multicenter, randOmized, Double-blind, placebo-controlled, stUdy to evaLuate the safety and efficacy of Alpha-1 AntiTrypsin for the prEvention of graft-versushost disease in patients receiving hematopoietic cell transplant (MODULAATE Study)	RBWH
Upper GI	EXPAN	Exercise medicine as chemotherapy adjunct: a multicomponent program in pancreatic cancer patients receiving neoadjuvant therapy	TPCH
Upper GI	CA240-0030	Phase 2/3 study with BMS-986504, Gemcitabine & Nab-Paclitaxel in participants with untreated Metastatic PDAC with homozygous MTAP Deletion.	RBWH

Clinical Trials

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