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

NCT03682068 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1246

Last updated 2026-02-03

No results posted yet for this study

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).

Conditions

  • Unresectable Locally Advanced Urothelial Cancer
  • Metastatic Urothelial Cancer

Interventions

DRUG

Durvalumab

Durvalumab IV (intravenous infusion)

DRUG

Tremelimumab

Tremelimumab IV (intravenous infusion)

DRUG

Cisplatin + Gemcitabine

Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.

DRUG

Carboplatin + Gemcitabine

Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-27
Primary Completion
2026-04-29
Completion
2026-04-29
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Philippines
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682068 on ClinicalTrials.gov