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ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

NCT02773849 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2024-07-29

Study results available
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Summary

Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III study is designed to expand those observations using a high dose of ADSTILADRIN in patients that are "BCG Unresponsive" which refers to patients with high-grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG.

Conditions

  • Superficial Bladder Cancer

Interventions

BIOLOGICAL

ADSTILADRIN

Sponsors & Collaborators

  • FKD Therapies Oy

    collaborator INDUSTRY

  • Society of Urologic Oncology Clinical Trials Consortium

    collaborator OTHER

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Stephen Boorjian, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-19
Primary Completion
2019-05-24
Completion
2023-05-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02773849 on ClinicalTrials.gov