Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03682068 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Metastatic Urothelial Cancer and Unresectable Locally Advanced Urothelial Cancer, sponsored by AstraZeneca.

Active
Registry status
Phase 3
Development phase
1,246
Enrollment target
20
Study locations

NCT03682068 is a Phase 3 study of Metastatic Urothelial Cancer and Unresectable Locally Advanced Urothelial Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 1,246 participants, above the 403-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (209% higher). The trial reports 20 study locations across 13 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03682068, a Phase 3 study of Metastatic Urothelial Cancer and Unresectable Locally Advanced Urothelial Cancer, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,246 participants
Enrollment target
20
Study locations

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 Studied

Metastatic Urothelial Cancer Unresectable Locally Advanced Urothelial Cancer

Interventions

  • DRUG Durvalumab
  • DRUG Tremelimumab
  • DRUG Cisplatin + Gemcitabine
  • DRUG Carboplatin + Gemcitabine

Study Locations (20)

California

  • Research Site - Bakersfield
  • Research Site - Fullerton
  • Research Site - Los Angeles
  • Research Site - Salinas
  • Research Site - Santa Barbara
  • Research Site - Truckee

New York

  • Research Site - New Hyde Park
  • Research Site - New York
  • Research Site - New York

Alabama

  • Research Site - Birmingham

Connecticut

  • Research Site - New Haven

District of Columbia

  • Research Site - Washington D.C.

Florida

  • Research Site - Orlando

Illinois

  • Research Site - Chicago

Indiana

  • Research Site - Fort Wayne

Trial Details

FieldValue
Enrollment Target 1,246 participants
Start Date 2018-09-27
Est. Completion 2026-04-29
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03682068

The ClinicalTrials.gov registry entry for NCT03682068 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,246 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 403-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (209% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Metastatic Urothelial Cancer appearing as the primary indexed condition, and to 4 interventions - of which Durvalumab is the first listed.

NCT03682068 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, New York, Alabama.

Frequently Asked Questions

What is clinical trial NCT03682068 about?

NCT03682068 is a clinical study titled "Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer". 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 ve...

What is the current status of trial NCT03682068?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,246 participants. The study started on 2018-09-27. Estimated completion is 2026-04-29.

What conditions does trial NCT03682068 study?

This clinical trial studies the following conditions: Metastatic Urothelial Cancer, Unresectable Locally Advanced Urothelial Cancer.

What interventions are being tested in trial NCT03682068?

The interventions under investigation include: Durvalumab (DRUG), Tremelimumab (DRUG), Cisplatin + Gemcitabine (DRUG), Carboplatin + Gemcitabine (DRUG).

Who is sponsoring clinical trial NCT03682068?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03682068 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Urothelial Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Metastatic Urothelial Cancer

All registered trials for this condition

Unresectable Locally Advanced Urothelial Cancer

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.