CA209-901 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Kidney<br/>CancersCancer LocationKidney
Cancers

Systemic therapy | Urinary systemBladder,Kidney,Urothelial

Trial Overview Read MoreRead more

This phase III trial is trying to determine whether the combination of two investigational immunotherapies (ipilimumab and nivolumab) or the combination of an investigational immunotherapy (nivolumab) and chemotherapy is better than recieveing chemotherapy alone in treating patients with urothelial cancer that has spread to other parts of their body.
 

This trial is treating patients with Urothelial Cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • 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, 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

Commercial Sponsor

Bristol-Myers Squibb (BMS)

Summary

In this trial, participants will be randomized into four arms. In the first arm (Arm A), participants will receive a specified dose of nivolumab and ipilimumab on specified days. In the second arm (Arm B), participants will receive a specified dose of gemcitabine / cisplatin or gemcitabine / carboplatin chemotherapy on specified days. In the third arm (Arm C), participants will receive a specified dose of nivolumab, plus gemcitabine-cisplatin chemotherapy, followed by nivolumab on specified days. In the final arm (Arm D), participants will receive a specified dose of gemcitabine-cisplatin chemotherapy only on specified days.

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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