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Virus Therapy

ADSTILADRIN for Bladder Cancer

Phase 3

Waitlist Available

Led By Stephen Boorjian, MD

Research Sponsored by Ferring Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

Study Summary

This trial is testing a new, high-dose treatment for patients with a type of bladder cancer that doesn't respond well to other treatments.

Eligible Conditions

Superficial Bladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients With a Complete Response Rate in Patients With Carcinoma in Situ (CIS), With or Without Concomitant High-grade Ta or T1 Papillary Disease.

Secondary outcome measures

Anti-adenoviral Antibody Levels for Correlation to Response Rate

Durability of Complete Response in Patients With CIS (With or Without Concomitant Ta or T1 Papillary Disease) Who Achieve a Complete Response.

Durability of Event-free Survival in Patients With High-grade Ta or T1 Papillary Disease (Without Concomitant CIS), Who Have no Recurrence of High-grade Ta or T1 Papillary Disease.

+5 more

Side effects data

From 2023 Phase 3 trial • 157 Patients • NCT02773849

35%

Instillation site discharge

27%

Fatigue

21%

Bladder spasm

18%

Haematuria

18%

Micturition urgency

17%

Chills

17%

Pyrexia

15%

Headache

14%

Dysuria

Diarrhoea

Urinary tract infection

Pain

Bladder pain

Nausea

Pollakiuria

Hypertension

Nasopharyngitis

Myalgia

Dizziness

Urinary incontinence

Arthralgia

Back pain

Influenza like illness

Vomiting

Sinusitus

Decreased appetite

Abdominal pain

Malaise

Sepsis

Dehydration

Brain oedema

Cough

Acute coronary syndrome

Arrhythmia

Atrial fibrillation

Coronary Artery Disease

Bronchitis

Hypoaesthesia

100%

80%

60%

40%

20%

Study treatment Arm

Carcinoma in Situ

Ta/T1 High-grade Disease Without Concomitant CIS

TEAE Total Study

Trial Design

1Treatment groups

Experimental Treatment

Group I: ADSTILADRINExperimental Treatment1 Intervention

Intravesical administration of ADSTILADRIN into the bladder

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ADSTILADRIN

2016

Completed Phase 3

~160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ferring PharmaceuticalsLead Sponsor

313 Previous Clinical Trials

440,701 Total Patients Enrolled

FKD Therapies OyIndustry Sponsor

1 Previous Clinical Trials

40 Total Patients Enrolled

Society of Urologic Oncology Clinical Trials ConsortiumOTHER

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a potential for INSTILADRIN to have adverse effects on people?

"There is existing data from earlier trials to support the efficacy of INSTILADRIN as well as multiple rounds of data affirming its safety, so it received a score of 3."

Answered by AI

What are the researchers investigating in this clinical trial?

"According to the sponsor of the clinical trial, FKD Therapies Oy, the primary outcome of the study will be the complete response rate in patients with Carcinoma in situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease, over a 12-month period. Additionally, the study will assess secondary outcomes including the safety of ADSTILADRIN, which will be monitored for treatment emergent adverse events, the incidence of cystectomy, and the durability of response during the long term follow up period."

Answered by AI

Are volunteers being accepted for this research project at this time?

"From what is publicly available on clinicaltrials.gov, it seems as if this trial is not currently looking for new participants. Although, this could change in the future as the last update was on September 20th, 2022. There are 327 other trials that are actively recruiting patients."

Answered by AI

Are there different research facilities overseeing this project?

"This trial has 35 different locations where it is currently operational, these locations include The Urology Center of Colorado in Denver, Carolina Urologic research Center in Myrtle Beach, University of Virginia Health System in Charlottesville, and 32 others."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Intravesical Nadofaragene Firadenovec Gene Therapy for Bcg-unresponsive Non-muscle-invasive Bladder Cancer: A Single-arm, Open-label, Repeat-dose Clinical Trial

Boorjian, Stephen A, Mehrdad Alemozaffar, Badrinath R Konety, Neal D Shore, Leonard G Gomella, Ashish M Kamat, Trinity J Bivalacqua, et al.. 2021. “Intravesical Nadofaragene Firadenovec Gene Therapy for Bcg-unresponsive Non-muscle-invasive Bladder Cancer: A Single-arm, Open-label, Repeat-dose Clinical Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(20)30540-4.

The Lancet OncologyJournal

Intravesical Nadofaragene Firadenovec Gene Therapy for Bcg-unresponsive Non-muscle-invasive Bladder Cancer: A Single-arm, Open-label, Repeat-dose Clinical Trial

clinicaltrials.govStudy

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

2016. "ADSTILADRIN (=INSTILADRIN) in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02773849.