Study of Durvalumab Given with Chemotherapy, Durvalumab in Combination with Tremelimumab Given with Chemotherapy, or Chemotherapy in Patients with Unresectable Urothelial Cancer - NILE

Study identifier:D933SC00001

ClinicalTrials.gov identifier:NCT03682068

EudraCT identifier:2018-001883-48

CTIS identifier:2024-510976-19-00

Recruitment Complete

Official 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.

Medical condition

Unresectable Locally Advanced Urothelial Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Durvalumab, Tremelimumab, Cisplatin + Gemcitabine, Carboplatin + Gemcitabine

Sex

All

Actual Enrollment

1244

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 27 Sept 2018
Estimated Primary Completion Date: 30 Aug 2024
Estimated Study Completion Date: 30 Jun 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria