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.

 

#UpFrontPSMA

Registered Title   #UpFrontPSMA : A Randomised Phase 2 Study of Sequential 177Lu-PSMA617 and Docetaxel Versus Docetaxel in Metastatic Hormone-Naive Prostate Cancer
Purpose  This phase 2 randomised clinical trial will compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own in patients with newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC).
Lay Summary   N/A
WA Trial Sites   (oncology) Ph. 08 615 26530
 Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

ENZA-p (ANZUP1901)

Registered Title  ENZA-p: A Randomised Phase II Trial Using PSMA as a Therapeutic Agent and Prognostic Indicator in Men With Metastatic Castration-resistant Prostate Cancer Treated With Enzalutamide
Purpose  This phase 2 randomised clinical trial will investigate the activity and safety of adding
Lu-PSMA to enzalutamide in patients with metastatic castrate resistant prostate cancer
(mCRPC) not previously treated with chemotherapy.
Lay Summary  N/A
WA Trial Sites  (oncology) Ph. 08 615 26530
 Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

COSMIC-313 / XL184-313

Registered Title  Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
Purpose  This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 676 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio (~338 per treatment arm) at approximately 150 sites.
Lay Summary  N/A
WA Trial Sites    Ph. (08) 6465 9204
Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

CheckMate 901

Registered Title  A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer
Purpose  The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating patients with previously untreated inoperable or metastatic urothelial cancer.
Lay Summary  N/A
WA Trial Sites   Ph. (08) 9242 7640
Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

BCG+MM (ANZUP1301)

Registered Title Adding Mitomycin to Bacillus of Calmette-Guerin (BCG) as Adjuvant Intravesical Therapy for High-risk, Non-Muscle-invasive Bladder Cancer: a Randomised Phase 3 Trial
Purpose  Open label, randomised phase 3 trial of the addition of Mitomycin to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer. The study aim is to compare disease-free survival between treatment arms: BCG alone versus Mitomyicn in addition to BCG.
Lay Summary  N/A
WA Trial Sites  Urology
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

APOLLO

Registered Title  A Phase 1/2 Dose Escalation and Expansion Study of Combination APL-501 or Nivolumab With APL-101 in Locally Advanced or Metastatic Hepatocellular and Renal Cell Carcinoma
Purpose

This is an open-label Phase 1/2 study to assess the safety and tolerability of combination
PD-1 inhibitor (APL-501 or nivolumab) administered concomitantly with c-Met inhibitor
(APL-101), to determine the recommended Phase 2 dose of the combination, and to obtain
preliminary efficacy in HCC or RCC subjects with advanced or metastatic disease that have not
been previously treated with a PD 1 inhibitor or a c-Met inhibitor. 

Lay Summary  N/A
WA Trial Sites

 Ph. (08) 9242 7640

Ph. 08 615 26530

Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

NINJA

Registered Title The NINJA Clinical Trial: Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation (TROG 18.01 NINJA)
Purpose "The NINJA clinical trial aims to compare two emerging schedules of radiotherapy in the treatment of prostate cancer.
Lay Summary  N/A
WA Trial Sites  Ph. (08) 6383 3204
Links Australian New Zealand Clinical Trial Registry 

Acknowledgments: Australian New Zealand Clinical Trial Registry

 

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

 

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

 

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

 

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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