Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer

Summary

This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

Timeline

Start

2018-09-27

Primary completion

2026-06-01

Completion

2027-06-01

Publications

• Mamede I, Escalante-Romero L, Celso DSG, Reis PCA, Dacoregio MI, Alves AC, Stecca C. Immunotherapy Plus Chemotherapy Versus Chemotherapy Alone as First-Line Treatment for Advanced Urothelial Cancer: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials. Clin Genitourin Cancer. 2024 Oct;22(5):102154. doi: 10.1016/j.clgc.2024.102154. Epub 2024 Jul 11.

Drugs

Indications