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

ACTIVE NOT RECRUITING Phase 3

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

NCT03682068 · View on ClinicalTrials.gov ↗

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).

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

1,053 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03682068 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, New York, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03682068?

The interventions under investigation include: Durvalumab (DRUG), Tremelimumab (DRUG), Cisplatin + Gemcitabine (DRUG), Carboplatin + Gemcitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03682068?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial