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.

 

MK6482-012

Registered Title   An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Purpose   The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus
belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab
plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell
carcinoma (ccRCC).
Lay Summary   N/A
WA Trial Sites   
Links  US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

3475-B61

Registered Title   A Phase 2, Single-arm, Open-label Clinical Trial of Pembrolizumab Plus Lenvatinib in Participants With First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (nccRCC) (KEYNOTE-B61)
Purpose  This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival. 
Lay Summary   N/A
WA Trial Sites   Oncology Ph.08 615 26530
Links  US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

KEYNOTE-992

Registered Title  A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Participants With Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)
Purpose   This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.
Lay Summary   
WA Trial Sites   Radiation Oncology Ph.(08) 6383 3204
Links   US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

P3BEP (ANZUP1302)

Registered Title   Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
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  Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current gold standard treatment for germ cell tumours, which is a chemotherapy combination called BEP (bleomycin, etoposide and cisplatin) administered on a 3 weekly cycle. BEP is given with a drug called pegfilgrastim which encourages white blood cell production and prevents blood cell complications of chemotherapy. Participants in the other group will receive the same dose of BEP but on a 2 weekly schedule. This is called 'accelerated BEP'.
WA Trial Sites   Oncology Ph. O8 615 26530
 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

 

#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

 

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

 

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

 

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

 

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

 

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

 

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

 

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