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.
| Disease | Trial name | Trial description | Hospital |
|---|---|---|---|
| Acute Leukaemia | ALLG NBCR | Australasian Leukaemia and Lymphoma Group National Blood Cancer Registry | RBWH |
| Acute Lymphoblastic Leukaemia | ALLG LS17 REGALLIA | Registry of acute lymphoblastic leukaemia in Australasia associated correlative studies | RBWH |
| Breast | TABITHA | Study of the clinical outcomes and analysis of anti-HER2 therapy in treatment of metastatic HER2 positive 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 |
| 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 |
| 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 |
| 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 |
| 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 | BLADDA Project | Bladder and Urothelial Cancer Data- and Biobank | RBWH |
| Genito-Urinary | KRAB | Kidney canceR Australian registry 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 | 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 | 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 | P3BEP | A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for participants with intermediate and poor-risk advanced germ cell tumours. | 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 | TheraPb | Phase I Biodistribution and Dosimetry Study of Pb-ADVC001 in Metastatic Prostate Adenocarcinoma | RBWH |
| Genito-Urinary | CLIMATE | CLIMATE: Assessing the Clinical utility of miR-371a-3p as a marker of residual disease in Clinical Stage 1 Testicular Germ Cell Tumour, following orchidectomy (ANZUP 1906). | RBWH |
| Genito-Urinary | KEYNOTE-365 | Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) | RBWH |
| Gynaecological | PARAGON-II | A Phase 2 basket study of an ARomatase inhibitor plus PI3KCA inhibitor or CDK4/6 inhibitor in women with hormone receptor positive recurrent/metastatic Gynaecological Neoplasms – PARAGON-II | RBWH |
| Gynaecological | ZOvCa | A phase 1 PET-CT study of 89Zr-hu/mo-10D7 in patients with advanced epithelial Ovarian Cancer | RBWH |
| Gynaecological | ADELE | ADELE: ADjuvant tislelizumab plus chemotherapy after post-operative pelvic chemoradiation in high risk EndometriaL cancEr. | RBWH |
| Gynaecological | EPOCH | Eribulin and Pembrolizumab in Ovarian/uterine Carcinosarcoma and sarcoma: Phase II open labelled study comparing the use of single agent Eribulin versus Eribulin in combination with pembrolizumab in relapsed tubo-ovarian or uterine carcinosarcoma. | RBWH |
| Gynaecological | TroFuse (MK-2870-020) | A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice as Second-Line or Third-Line Treatment for Participants with Recurrent or Metastatic Cervical Cancer | RBWH |
| Haem - Other | INCYTE INCA33989-101 | A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms | 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 | 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 |
| Haemophilia | Vega Therapeutics VGA039-CP001 | A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of VGA039 Following Intravenous or Subcutaneous Administration of Single Ascending Doses in Healthy Adults and Adult Patients with von Willebrand Disease | 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 | SAHMRI PREACH-M CMML | Precision Medicine for Chronic Myelomonocytic Leukaemia: A phase II Trial Studying the Efficacy of Lenzilumab and High Dose Ascorbate with Azacitidine Based on Molecular Profiling (PREACH-M). | 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 | 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 | AURORA | AUstralasian thoRacic cancers lOngitudinal cohoRt study and biobAnk | 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 | eVOLVE-Meso | A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination with Carboplatin plus Pemetrexed Versus Platinum plus Pemetrexed or Nivolumab plus Ipilimumab in Participants with Unresectable Pleural Mesothelioma | 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 | SHERLOCK | Sotorasib witH bEvacizumab fiRst Line cOmbined with Chemotherapy for KRAS G12C NSCLC (SHERLOCK) Phase 2 trial of sotorasib in combination with carboplatin-pemetrexed and bevacizumab-biosimilar as first line treatment for advanced non-squamous non-small cell lung cancer with KRAS G12C mutation | 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 |
| Lymphoma | Kite Pharma KT-US-656-0601 | A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects with Relapsed or Refractory Large B-cell Lymphoma | RBWH |
| Lymphoma | Janssen 90009530LYM1001 CD20 Mono CAR | A Phase 1b Multicenter, Open-Label, Study of JNJ-90009530, an Autologous Anti-CD20 CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (90009530LYM1001) | RBWH |
| Lymphoma | ALLG NHL38 Epcor-Sandwich | A phase II multicentre, single arm, open-label trial of epcoritamab-containing combination salvage therapy followed by autologous stem cell transplantation and epcoritamab consolidation in patients with first relapse of large B-cell lymphoma | RBWH |
| Lymphoma | CARTRW | Clinical, laboratory and radiological predictive factors for safety and efficacy of chimeric antigen receptor (CAR) T-cell therapy in Australia: A multi-centre real-world study | RBWH |
| Lymphoma | AbbVie M22-003 EPCOR FL-2 | A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2) | 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 | Kite Pharma KT-US-484-0136 ZUMA-23 | An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Treatment as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma (ZUMA-23) Hospital: RBWH | RBWH |
| Multiple Myeloma – MM | EMN28 CARTITUDE 6 E-magine | A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible | RBWH |
| Multiple Solid Tumours | KEYNOTE-158 | A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors | RBWH |
| Myeloma | MRDR | Myeloma and Related Diseases Registry | RBWH |
| Myeloma - MM | Regeneron LINKER RGN5458-ONC-2245 | Open-Label Randomized study to evaluate linvoseltamab versus EPd in Relapsed/Refractory Multiple Myeloma - RGN5458-ONC-2245 LINKER-MM3 | RBWH |
| Myeloma - MM | AMaRC RIDDLE-M-X | Risk Directed Front-Line Therapy for Multiple Myeloma incorporating Selinexor: The RIDDLE-M-X 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 | 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 | STOPNET | A randomised study of cessation of somatostatin analogues after Peptide Receptor Radionuclide Therapy in Mid, Hind-Gut and Pancreatic Neuroendocrine tumours | 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 | GeneScreen 5-FU | DPYD Genotype-guided dose Personalisation for Fluoropyrimidine prescribing in Cancer | TPCH |
| Other | GeneScreen 5-FU | DPYD Genotype-guided dose Personalisation for Fluoropyrimidine prescribing in Cancer | NLH-COHD |
| 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 | 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 | ARASTEP | A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of 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 |
| Prostate | DECREASE | Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer detected by PSMA | 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 | Alpha-9 (A9T-3202-3308-01) | A Multicentre, Phase 1 Study Investigating the Safety, Tumor Uptake, Biodistribution, and Dosimetry of ⁶⁸Ga-A9T-3202 in Participants with Locally Advanced or Metastatic Melanoma | 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 |
| Skin | V940-007 (INTerpath-007) | A Phase 2/3, adaptive, randomized, open-label, clinical study to evaluate neoadjuvant and adjuvant V940 (mRNA-4157) in combination with pembrolizumab (MK-3475) versus standard of care, and pembrolizumab monotherapy in participants with resectable locally advanced cutaneous squamous cell carcinoma (LA cSCC) | RBWH |
| Skin | GoTHAM | TarGeted THerapy and Avelumab in Merkel Cell Carcinoma - A phase Ib/II study of combination avelumab with peptide receptor radionuclide therapy or conventional fractionated radiotherapy in patients with metastatic Merkel cell carcinoma | 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 | R3ACT Randomised | A randomised trial of most closely HLA-matched third-party donor-derived virus-specific cytotoxic T-lymphocytes in patients with untreated viral infection post-allogeneic stem cell transplantation (R3ACT Randomised (R3R)) | RBWH |
| Transplant - aGVHD | Cynata Therapeutics CYP-GVHD-P2-01 | CYP-GVHD-P2-01 - Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of CYP-001 in Combination with Corticosteroids vs Corticosteroids Alone for the Treatment of High-Risk Acute Graft Versus Host Disease | 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 |
| Transplant - cGVHD | SANOFI EFC17757 cGVHD ROCKnrol-1 | A randomized, double-blind, multicenter, Phase 3 study to evaluate efficacy and safety of belumosudil in combination with corticosteroids versus placebo in combination with corticosteroids in participants at least 12 years of age with newly diagnosed chronic graft versus host disease (cGVHD) | RBWH |
| Upper GI | MK-9999-02A | A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers | RBWH |