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

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)

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)

Acknowledgements: US National Library of Medicine

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