ClinicalTrials.gov record
Completed Phase 1 Interventional Results available

Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)

ClinicalTrials.gov ID: NCT03258593

Public ClinicalTrials.gov record NCT03258593. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 5:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I Single-Arm Study of the Combination of Durvalumab (MEDI4736) and Vicineum (Oportuzumab Monatox, VB4-845) in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)

Study identification

NCT ID
NCT03258593
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
National Cancer Institute (NCI)
NIH
Enrollment
15 participants

Conditions and interventions

Interventions

  • Acetaminophen Drug
  • Antihistamine Drug
  • Bladder Biopsy Procedure
  • CT Diagnostic Test
  • Cystoscopy Procedure
  • Durvalumab Drug
  • Electrocardiogram Diagnostic Test
  • MRI Diagnostic Test
  • TURBT Procedure
  • Urine cytology Diagnostic Test
  • Vicineum Drug

Drug · Procedure · Diagnostic Test

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 6, 2018
Primary completion
Jul 31, 2022
Completion
Oct 16, 2022
Last update posted
Mar 16, 2026

2018 – 2022

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03258593, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 16, 2026 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03258593 live on ClinicalTrials.gov.

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