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

RecruitingStatus 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

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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

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
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.

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