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Bladder and Renal

The following list provides a brief description of bladder and renal cancer trials that are recruiting participants in Western Australia. If you would like more information please follow the links provided, contact one of the trial sites or speak with your doctor.

Please note that this list is based on information provided to the Cancer Council by WA hospitals and may not include all clinical trials that are running in WA.

Where ‘N/A' appears - this means the lacking information has not been provided to date to the Cancer Council.

NIAGARA / D933RC00001

Registered Title	A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer.
Purpose	A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer
Lay Summary	N/A
WA Trial Sites	Cancer Centre Clinical Trials Unit Ph. 08 615 26530
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

FIGHT-205 - (ON HOLD)

Registered Title	A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement (FIGHT-205)
Purpose	The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment.
Lay Summary	N/A
WA Trial Sites	Affinity Clinical Research Ph. (08) 9242 7640
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

ROAM

Registered Title	Radiation versus Observation following surgical resection of Atypical Meningioma: a randomised controlled trial
Purpose	Atypical meningioma is a tumour that arises from the lining of the brain. It mostly affects adults, with most patients in the 40-60 year age group. The primary treatment for atypical meningioma is surgical removal, but with surgery alone up to 40% of patients will experience recurrence. Because of this risk, some clinicians give early radiotherapy, whilst others advise regular monitoring with radiotherapy given only at recurrence. Currently there is no consensus as to which of these two approaches is best. This randomised controlled trial will compare the two approaches, and aims to determine whether early radiotherapy reduces the risk of tumour recurrence compared to regular monitoring in newly diagnosed atypical meningioma.
Lay Summary	N/A
WA Trial Sites	Radiation Oncology Ph.(08)6383 3204
Links	ISRCTN Registry

CA224-020

Registered Title	A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Purpose	The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.
Lay Summary	N/A
WA Trial Sites	Linear Clinical Research Ph. 08 6382 5513
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

BGB-900-103

Registered Title	A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Purpose	This is an open-label, multicenter, non-randomized Phase 1b clinical trial for patients with histologically or cytologically confirmed locally advanced or metastatic tumors including non-squamous or squamous NSCLC, RCC, OC, or melanoma.
Lay Summary	N/A
WA Trial Sites	Linear Clinical Research Ph. 08 6382 5513
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

PCR-MIB (ANZUP1502)

Registered Title	Pembrolizumab With Chemoradiotherapy as Treatment for Muscle Invasive Bladder Cancer
Purpose	This study will enrol patients with maximally resected (via transurethral resection (TURBT) non-metastatic muscle invasive bladder cancer, who either wish to attempt bladder preservation therapy or are ineligible for cystectomy
Lay Summary	N/A
WA Trial Sites	SCGH Medical Oncology Ph. (08) 6383 3000
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

KEYPAD (ANZUP1601)

Registered Title	Denosumab and Pembrolizumab in Clear Cell Renal Carcinoma: a Phase II Trial (ANZUP 1601)
Purpose	This Single-arm, multicentre, phase 2 trial aims determine the activity and safety of pembrolizumab and denosumab in advanced clear cell renal cell carcinoma (ccRCC).
Lay Summary	N/A
WA Trial Sites	Cancer Centre Clinical Trials Unit Ph.08 615 26530
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

NILE

Registered Title	A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer
Purpose	This is a study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).
Lay Summary	N/A
WA Trial Sites	FSH (oncology) Cancer Centre Clinical Trials Unit Ph. 08 615 26530
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

CA017-078

Registered Title	A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer
Purpose	A study to evaluate nivolumab + chemotherapy or nivolumab/ BMS-986205 + chemotherapy followed by continued Immuno-Oncology therapy after radical cystectomy (RC) compared with neoadjuvant standard of care (SOC) chemotherapy alone in patients with muscle-invasive bladder cancer (MIBC)
Lay Summary	N/A
WA Trial Sites	Murdoch Oncology Clinical Trials Unit Ph. (08) 9428 8539
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

PIVOT-10 / CA045-012

Registered Title	A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients
Purpose	The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.
Lay Summary	N/A
WA Trial Sites	Murdoch Oncology Clinical Trials Unit Ph.(08) 9428 8539
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

P3BEP

Registered Title	In patients with intermediate and poor-risk metastatic germ cell tumours is an accelerated BEP chemotherapy regimen as good as, or better than, the standard BEP chemotherapy regimen for response rate.
Purpose	The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males and females with intermediate and poor-risk metastatic germ cell tumours.
Lay Summary	N/A
WA Trial Sites	Cancer Centre Clinical Trials Unit Ph. 08 615 26530
Links	Australian New Zeland Clinical Trial Registry

Acknowledgments: Australian New Zeland Clinical Trial Registry

CA045-009

Registered Title	A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus NKTR-214, Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible
Purpose	The purpose of the study is to see if treatment with nivolumab plus NKTR-214 or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.
Lay Summary	N/A
WA Trial Sites	Murdoch Oncology Clinical Trials Unit Ph. (08) 9428 8539
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

Pivot -09

Registered Title	A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma
Purpose	The main purpose of this study is to compare the overall response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).
Lay Summary	N/A
WA Trial Sites	Murdoch Oncology Clinical Trials Unit Ph. (08) 9428 8539
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

THOR (ST-617)

Registered Title	A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
Purpose	The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).
Lay Summary	N/A
WA Trial Sites	Cancer Centre Clinical Trials Unit (08) 615 26530
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

ANZUP - FASTRACK II

Registered Title	A Multicentre Phase II clinical Trial of STereotactic Ablative Body Radiotherapy for Primary Kidney Cancer (TROG 15.03 FASTRACK II)
Purpose	This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers.
Lay Summary	N/A
WA Trial Sites	SCGH Medical Oncology Ph. (08) 6383 3000
Links	Australian New Zealand Clinical Trial Registry

Acknowledgments: Australian New Zeland Clinical Trial Registry

KEYPAD

Registered Title	KidnEY cancer Pembrolizumab And Denosumab. Denosumab and Pembrolizumab in clear cell renal carcinoma: a phase II trial
Purpose	This study is designed to test the safety and potential benefit of adding an existing drug used for bone protection (denosumab) to a new immune stimulating drug (pembrolizumab).
Summary	Who is it for? You may be eligible for this study if you have a confirmed unresectable or metastatic clear cell renal carcinoma, and you have adequate liver and bone function. Study details All participants will receive the two study drugs, along with vitamin D and calcium (mode of administration up to the discretion of the treating clinician). Treatment will continue until disease progression or toxicity. Patients will be monitored for tumour response and skeleton health. It is hoped this combination of medications will be as safe, and provide more benefit than the immune stimulating drug alone in treating kidney cancer.
WA Trial Sites	Cancer Centre Clinical Trials Unit (08) 615 26530
Links	Australian New Zealand Clinical Trial Registry

Acknowledgments: Australian New Zeland Clinical Trial Registry

ANZUP 1502 Bladder Study

Registered Title	Pembrolizumab With Chemoradiotherapy as Treatment for Muscle Invasive Bladder Cancer.
Purpose	The objective of the study is to assess the safety and feasibility of combining pembrolizumab with chemoradiotherapy. The primary endpoint assessed will be safety, as defined by a satisfactorily low rate of unacceptable toxicity (G3-4 adverse events or failure of completion of planned chemotherapy and radiotherapy according to defined parameters). The secondary endpoint will be efficacy, as assessed by complete response rate of the primary tumour at first post chemoradiotherapy cystoscopic assessment. Exploratory analysis will include assessment of tumour histopathological, molecular, genetic and immunological parameters.
Lay Summary	N/A
WA Trial Sites	SCGH Medical Oncology Ph. (08) 6383 3000
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

RAIDER

Registered Title	A Randomised Phase II Trial of Adaptive Image Guided Standard or Dose Escalated Tumour Boost Radiotherapy in the Treatment of Transitional Cell Carcinoma of the Bladder
Purpose	Bladder cancer is the seventh most common cancer in the UK, with 10,399 new cases diagnosed in 2011. In a quarter of these cases the cancer has infiltrated the muscular wall of the bladder (muscle invasive) and is life threatening. This type of bladder cancer is usually treated either with surgical removal of the bladder, or daily radiotherapy treatment (high strength xrays which kill cells), given every day for 4 or 7 weeks. RAIDER will investigate methods which have the potential to improve how well this radiotherapy works.
Lay Summary	N/A
WA trial Sites	SCGH - Radiation Oncology (08) 6383 3204
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

Checkmate-914

Registered Title	A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
Purpose	The purpose of this study is to determine whether the combination of nivolumab and ipilimumab is safe and effective for delaying or preventing recurrence of cancer in patients who have experienced the partial or entire removal of a kidney
Lay Summary	N/A
WA Trial Sites	Murdoch Oncology Clinical Trials Unit (08) 9428 8556
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

CANTATA

Registered Title	A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) - CANTATA
Purpose	This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma.
Lay Summary	N/A
WA Trial Sites	Ph. 08 9346 6637
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

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