Study Summary
This trial will test a drug, given through a catheter, for side effects and efficacy in treating non-muscle invasive bladder cancer.
- Non-muscle Invasive Bladder Cancer
- Bladder Cancer
- Carcinoma in Situ
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
3 Primary · 11 Secondary · Reporting Duration: Up to 5 years
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Enfortumab vedotin: Dose expansion cohort
1 of 2
Enfortumab vedotin: Dose escalation cohort
1 of 2
Experimental Treatment
58 Total Participants · 2 Treatment Groups
Primary Treatment: Enfortumab vedotin · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Ohio | 100.0% |
What site did they apply to?
| Johns Hopkins Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "I have had 3 6 week treatments 1st was BCG, second was Gemcitabine and Taxotere as was the 3rd which finished in April. Now they do not want to treat me any longer here in Ohio."
What questions have other patients asked about this trial?
- "1. Will I be taking a medication or will it be intravesicular?"
How many prior treatments have patients received?
| 3+ | 100.0% |
Frequently Asked Questions
Is there an ongoing recruitment process for this clinical experiment?
"The information on clinicaltrials.gov confirms that this investigation is in the midst of recruiting subjects. It was initially listed on December 7th 2021 and revised most recently on November 1st 2022." - Anonymous Online Contributor
In what scenarios is Enfortumab vedotin utilized most often?
"Enfortumab vedotin can be utilized in therapeutic operations, to combat metastatic urothelial cancer, and as an immunotherapeutic drug." - Anonymous Online Contributor
How many facilities are administering this research?
"This trial is being hosted at 8 different medical centres, such as Laura & Isaac Perlmutter Cancer Center at NYU Langone Health in New York, University of Texas Southwestern Medical Center in Dallas, and Site CA11001 in Toronto. A few other locations are also available for participants." - Anonymous Online Contributor
Are there any precedential experiments conducted with Enfortumab vedotin?
"The first clinical trial of enfortumab vedotin began in 2014 at US00019. Since then, 2 trials have concluded successfully and there are currently 18 ongoing studies recruiting patients, many located in the bustling city of New York." - Anonymous Online Contributor
What are the main goals of this research endeavor?
"The primary goal of this trial, which will be assessed over a roughly 1 year timeline, is to study the rate of dose-limiting toxicities. Secondary objectives include examining the trough concentration and area under the curve for enfortumab vedotin as well as investigating any antitherapeutic antibodies towards it." - Anonymous Online Contributor
Is this investigation pioneering in its approach?
"Presently, there are 18 Enfortumab vedotin clinical trials taking place worldwide in 377 cities and 44 countries. Seagen Inc. initiated the first study of this drug back in 2014 with 213 participants. In the years since then, two further investigations have finalised their Phase 1 stages." - Anonymous Online Contributor
How many participants are included in this investigation?
"Seagen Inc., the sponsor of this trial, requires 58 participants who meet the inclusion criteria in order to run it. The study will be conducted at Laura & Isaac Perlmutter Cancer Center at NYU Langone Health and University of Texas Southwestern Medical Center, among other locations." - Anonymous Online Contributor
Has Enfortumab vedotin been granted regulatory clearance to be marketed?
"Due to its Phase 1 status, the safety of enfortumab vedotin was estimated at a score of 1 as only minimal data exists regarding efficacy and safety." - Anonymous Online Contributor