NILE : A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18-99Age 18-99

Kidney<br/>CancersCancer LocationKidney
Cancers

Systemic therapy | Urinary systemBladder,Kidney,Urinary tract,Urothelial

Trial Overview Read MoreRead more

This phase III trial is assessing a first line treatment combining immunotherapy and chemotherapy, versus chemotherapy alone, in patients with locally advanced or metastatic urothelial cancer.
 

This trial is treating patients with urothelial cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • 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

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Scientific Title

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

Commercial Sponsor

AstraZeneca

Summary

In this trial, participants will be randomised into one of three arms. In Experimental Arm 1, participants will receive Durvalumab (intravenously every three weeks)in combination with standard of care chemotherapy (SoC), followed by Durvalumab monotherapy every four weeks. In Experimental Arm 2, participants will receive Durvalumab and Tremelimumab (intravenously every three weeks) in combination with SoC, followed by Durvalumab monotherapy every four weeks. In this Arm, Tremelimumab will be administered over four cycles. In the Active Comparator Arm, participants will receive SoC (with either cisplatin + gemcitabine OR carboplatin + gemcitabine) every three weeks for six cycles.

Recruiting Hospitals Read MoreRead more

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167

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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