Our Trials

Endocrinology and Diabetes

For more information please contact:

Elizabeth Mulrooney - Clinical Trial's Endocrinology and Diabetes 
4th Floor Daly Wing
Ph: (03) 9231 4765

Chronic Kidney Disease

TRCA-303 (VALOR-CKD)

A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safetu of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis

Recruitment on hold


Type 2 Diabetes & CKD

NovoNordisk NN9535-4321

FLOW - Effect of semaglutide versus placebo on the progression of renal impairement in subjects with type 2 diabetes and chronic kidney disease

Recruitment on hold 

 Type 1 Diabetes

Baker Heart and Diabetes - Nox 1 and 4 inhibition in type 1 diabetic kidney disease T1DGKT137831

A physician-initiated double-blind, randomised, placebo-controlled, phase 2 study evaluating the efficacy and safety of inhibition of NADPH Oxidase with the first-in-class Nox-1/4 inhibitor, GKT137831, in adults with type 1 diabetes and persistently elevated urinary albumin excertion

Recruitment on hold 
 Type 1 Diabetes
BANDIT (baricitinib in new onset type 1 diabetes)

BANDIT trial will test a treatment (baricitinib) intended to stop the immune system from destroying the insulin-producing cells of people aged 10 - 30 years old with newly diagnosed type 1 diabetes.

Recruitment open

Haematology

To view the current recruiting trials at the Haematology Clinical Trial Unit please click here.

Neurosciences

For more information please contact:
Alan Lai
Study Coordinator
alan.lai@unimelb.edu.au

Karen Sweerts
karen.mclean@svha.org.au

Epilepsy

A prospective study to assess the safety of a sub-scalp monitoring device for the recording of brain electrical activity associated with the occurrence of epileptic seizures

Open to recruitment

Neurosurgery

For more information please contact:
Emma Priest
Clinical Research Nurse
emma.priest@svha.org.au

Ph: (03) 9231 3551

Glioma Associated Seizures

Pegasus: Perampanel in glioma associated seizures – efficacy and safety: a pilot phase II randomised controlled trial

Open to recruitment

Oncology

For more information please contact:
oncologytrialcoordinators@svha.org.au

Lung

MK-7684A-006

Open-label phase 3 study of MK-7684A (vibostolimab with pembrolizumab) in combination with concurrent chemoradiotherapy followed by MK-7684A versus concurrent chemoradiotherapy followed by durvalumab in participants with unresectable, locally advanced, stage III NSCLC.

Recruitment open

SPARTA

Phase 1/2 multicentre study of the safety, pharmacokinetics, and preliminary efficacy of APL-101 in subjects with non-small cell lung cancer with c-Met EXON 14 skip mutations.

Recruitment open

TROG 20.01 – CHEST RT

A phase 2 study of platinum and etoposide chemotherapy, durvalumab with thoracic radiotherapy in the first-line treatment of patients with extensive-stage small-cell lung cancer (SCLC).

Recruitment open

eVOLVE-Lung02

A phase 3, two-arm, parallel, randomised, multi-centre, open-label, global study to determine the efficacy of volrustomig (MEDI5752) plus chemotherapy versus pembrolizumab plus chemotherapy for first-line treatment of patients with metastatic non-small cell lung cancer (mNSCLC).

Recruitment open

MoST 8

Single-arm, open-label, signal-seeking phase 2a trial of the activity of trastuzumab emtansine (T-DM1) in patients with tumours harbouring HER2 amplifications or mutations.

Recruitment open

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 IIA-IIIA EGFR-mutant non-small cell lung cancer following complete surgical resection.

Recruitment open

R3767-ONC-2236

A randomised, double-blind phase 2/3 study of fianlimab (anti-LAG-3 antibody), cemiplimab (anti-PD-1 antibody), and chemotherapy versus cemiplimab and chemotherapy in first-line treatment of patients with advanced NSCLC irrespective of PD-L1 expression levels.

Recruitment open

Breast

CELC-G-301

A phase 3, open-label, randomised, two-part study comparing gedatolisib in combination with palbociclib and fulvestrant to standard-of-care therapies in patients with HR-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor in combination with non-steroidal aromatase inhibitor therapy.

Recruitment open

EMBER-4

A randomised, open-label, phase 3 study of adjuvant imlunestrant vs standard adjuvant endocrine therapy in patients who have previously received 2 to 5 years of adjuvant endocrine therapy for ER-positive, HER2-negative early breast cancer with an increased risk of recurrence.

Recruitment open

EXPERT

Randomised phase 3 trial of adjuvant radiotherapy versus observation following breast-conserving surgery and endocrine therapy in patients with molecularly characterised luminal A early breast cancer.

Recruitment open

GS-US-586-6144

A phase 2, randomised, open-label study evaluating the safety and efficacy of magrolimab in combination with nab-paclitaxel or paclitaxel versus nab-paclitaxel or paclitaxel in previously untreated patients with metastatic triple-negative breast cancer.

Recruitment open

OPTIMA

Optimal personalised treatment of early breast cancer using multiparameter analysis.

Recruitment open

Head & Neck

BNT113-01 (AHEAD-MERIT)

An open-label, phase 2, randomised trial of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line therapy in patients with unresectable recurrent, or metastatic head & neck squamous cell carcinoma (HNSCC) which is positive for human papilloma virus 16 (HPV16+) and expresses PD-L1.

Recruitment open

Skin

C-POST

A randomised, placebo-controlled, double-blind study of adjuvant cemiplimab versus placebo after surgery and radiation therapy in patients with high-risk cutaneous squamous cell carcinoma.

Recruitment open

Upper GI

PALEO

Phase 2 clinical trial of chemoradioimmunotherapy for the alleviation of oesophageal cancer complications.

Recruitment open

ProvIDHe

An open-label, early access, phase 3b study of ivosidenib in patients with a pretreated locally advanced or metastatic cholangiocarcinoma.

Recruitment open

ZAP

A phase 2, open-label study to assess the antitumour activity and safety of zolbetuximab (IMAB362) in combination with chemotherapy as first-line treatment in metastatic pancreatic adenocarcinoma.

Recruitment open

PURPLE

Pancreatic cancer: understanding routine practice & lifting end results (PURPLE). A prospective pancreatic cancer clinical registry.

Recruitment open

Lower GI

MOUNTAINEER-03

An open-label, randomised, phase 3 study of tucatinib in combination with trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either cetuximab or bevacizumab as first-line treatment for subjects with HER2+ metastatic colorectal cancer.

Recruitment open

ALT-TRACC

Alternating oxaliplatin and irinotecan doublet schedules versus continuous doublet chemotherapy in previously untreated metastatic colorectal cancer: A treatment of recurrent and advanced colorectal cancer registry-based prospective randomised trial.

Recruitment open

TRACC-SELECT

Treatment of Australian colorectal cancer – selecting biomarkers of interest registry.

Recruitment open

Solid Tumours

CA052-002

A phase 1/2 study of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumours.

Recruitment open

CF33-hNIS-002

A phase 1, dose-escalation safety and tolerability study of VAXINIA (CF33-hNIS), administered intratumorally or intravenously as a monotherapy or in combination with pembrolizumab in adult patients with metastatic or advanced solid tumors (MAST).

Recruitment open

Brain

BRAIN registry

Brain registry Australia: Innovation and translation (BRAIN)

Recruitment open

LUMOS2

Low & anaplastic grade glioma umbrella study of molecular guided therapies.

Recruitment open

Other

IMPARP-HRD

An open-label, signal-seeking, translational phase 2 trial of pamiparib in combination with tislelizumab in patients with advanced tumours with homologous recombination repair defects.

Recruitment open

KEYNOTE-587

A multicentre, open-label, phase 3 extension trial to study the long-term safety and efficacy in participants with advanced tumours who are currently on treatment or in follow-up in a pembrolizumab trial.

Recruitment open

 

Palliative Care

For more information please contact:

Prof Jennifer Philip
jphilip@unimelb.edu.au

Indy Khera (for trials ANAM, STEP, and enhance)

indy.khera@svha.org.au

ANAM

A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Recruitment open


Care Plus

The Enhance care study: multi-site implementation of early palliative care in routine practice to improve health outcomes

Recruitment open

CHOICE

A phase II online randomised trial to assess the acceptability and feasibility of delivering online educational content involving different messages about palliative care

Recruitment open

ENhANCE

A multi-centre, randomised, phase IV study to compare the efficacy of oxycodone/naloxone vs oxycodone prolonged release tablets in patients with advanced cancer

Recruitment open

Lung Pro

Evaluating the symptoms and quality of life of advanced lung cancer patients in the Victorian Comprehensive Cancer Centre (VCCC) using patient reported outcome measures (PROMS) - A prospective, cross sectional study

Recruitment closed

PEARL

A randomised phase 3 trial of Palliative care Early in Advanced Lung Cancers

Recruitment open

StepCare

A Randomised Phase II Trial to Examine Feasibility of Standardised, Early Palliative Care (STEP Care) for Patients with Advanced Cancer and their Carers

Recruitment open