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A Phase III, Randomized, Open-label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Bladder Cancer

Status
Active
Cancer Type
Bladder Cancer
Trial Phase
Phase III
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT02516241
Protocol IDs
D419BC00001 (primary)
NCI-2015-02054
Study Sponsor
AstraZeneca Pharmaceuticals LP

Summary

A Phase III, Randomized, Open-label, Controlled, Multi-Center, Global Study of First-Line

MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care

Chemotherapy in Patients with Stage IV Urothelial Bladder Cancer

Objectives

This is a randomized, open-label, controlled, multi-center, global Phase III study to

determine the efficacy and safety of MEDI4736 monotherapy and MEDI4736 in combination with

tremelimumab versus SoC (cisplatin + gemcitabine or carboplatin + gemcitabine doublet)

first-line chemotherapy in treatment-naïve patients with histologically or cytologically

documented, unresectable, Stage IV transitional cell carcinoma (transitional cell and mixed

transitional/non-transitional cell histologies) of the urothelium. The patients will be

randomized in a 1:1:1 ratio to receive treatment with combination therapy, monotherapy, or

SoC (cisplatin + gemcitabine or carboplatin + gemcitabine, based on cisplatin eligibility).

Patients will be treated with MEDI4736 or MEDI4736 with tremelimumab for up to 12 months or

with SoC for up to 6 months. Patients will be followed for up to 2 years.

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