Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

CA045-009 : 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

Male or<br/>FemaleGender Male or
Female

Closed (no longer recruiting)Status Closed (no longer recruiting)

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Urinary System<br/>CancersCancer LocationUrinary System
Cancers

Systemic therapy | Urinary systemBladder

Trial Overview Read MoreRead more

This phase III trial is comparing pre- and post- surgical immunotherapy (Nivolumab alone or in combination with NKTR-214) with standard of care therapy in patients with muscle invasive bladder cancer who are unable to have a certain type of chemotherapy (Cisplatin).
 

This trial is treating patients with bladder cancer.

This is a systemic therapy trial.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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

Commercial Sponsor

Bristol-Myers Squibb (BMS)

Summary

Eligible patients will be randomised to receive: (1) Neoadjuvant nivolumab + NKTR-214, followed by radical cystectomy (RC), followed by adjuvant nivolumab + NKTR-214. (2) Neoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab. Or, (3) RC alone, without neoadjuvant or adjuvant therapy

Not Recruiting Hospitals Read MoreRead more

Closed

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

Next