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.

 

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

FSH - 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

Sir Charles Gairdner Hospital Logo

SCGH Medical Oncology
Ph. (08) 6383 3000

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

JAVELIN Bladder 100

Registered Title

A Phase 3, Multicenter, Multinational, Randomized, Open-Label, Parallel-Arm Study Of Avelumab* (MSB0010718C) Plus Best Supportive Care Versus Best Supportive Care Alone As A Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion Of First-line Platinum-containing Chemotherapy.

Purpose

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

Lay Summary

N/A

WA Trial Sites

St John of God Murdoch Logo

Tamsyn Whitcher
Murdoch Oncology Clinical Trials Unit
Ph. (08) 9428 8539
oncologytrials.murdoch@sjog.org.au

Fiona Stanley Hospital Logo

Caroline Stone
Clinical Trials Manager, Cancer Centre Clinical Trials Unit
Phone 08 615 26530 Fax 08 615 20954
caroline.stone@health.wa.gov.au

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

 

UNISoN

Registered Title
A Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602). 
 Purpose  The purpose of this study is to test the effectiveness, safety, and tolerability of Nivolumab (also known as Opdivo or BMS-936558) and Ipilumumab (also known as MDX-010 or Yervoy). Nivolumab and ipilimumab are antibodies (a type of human protein) that are being tested to see if they will allow the body's immune system to work against tumour cells. The immune system is the body's defence against cancer, bacteria and viruses. The effectiveness of nivolumab and ipilimumab in cancer of the kidney will be assessed by measuring the size of patient tumours via CT scans.
 Lay Summary
This study aims to evaluate the safety, tolerability and effectiveness of new treatments for kidney cancer called Nivolumab and Ipilimumab. The study is in two parts; in the first instance patients receive nivolumab alone. If this treatment is not effective patients may move onto the second part of the trial, where they receive nivolumab + ipilimumab. There is no placebo.

The reason to offer one treatment alone, followed by two treatments together is that it is thought that the double treatment may have more side-effects, but also may be effective in people in whom the single first treatment (nivolumab alone) has not helped.

Nivolumab and ipilimumab are experimental treatments. This means that they are not an approved treatment for non-clear cell kidney cancer in Australia.

 WA Trial Sites

 

FSH - Cancer Centre Clinical Trials Unit (08) 615 26530

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

Esai E7080-G000-218

Registered title
A Randomized, Double-blind, Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment 
 Purpose  Study E7080-G000-218 is a Randomized, Double-blind, Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate [ORR] at 24 weeks [ORR24W]) with an improved safety profile compared to lenvatinib 18 mg in combination with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any ≥ Grade 3 adverse events (AEs) in the first 24 weeks after randomization).
 Lay Summary
N/A
 WA Trial Sites
 FSH - Cancer Centre Clinical Trials Unit (08) 615 26530
 Links  Acknowledgements: US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

KEYNOTE-564

Registered Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564) 
 Purpose The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component.

The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.

 Lay Summary
 N/A
 WA Trial Sites

FSH - Cancer Centre Clinical Trials Unit (08) 615 26530

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

Checkmate-274

Registered Title
A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274) 
 Purpose  An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer (CheckMate 274)
 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


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

 

JAVELIN RENAL 101

Registered Title
 A Phase 3, Multinational, Randomized, Open-label, Parallel-arm Study Of Avelumab (msb0010718c) In Combination With Axitinib (Inlyta(Registered)) Versus Sunitinib (Sutent(Registered)) Monotherapy In The First-line Treatment Of Patients With Advanced Renal Cell Carcinoma
 Purpose  This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma
 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

 

 

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