Bladder Cancer study: Enfortumab vedotin
Official title Enfortumab Vedotin and Stereotactic Radiation for Localized Bladder Cancer
ClinicalTrials.gov ID: NCT06394570
What this study is testing
What is Enfortumab vedotin?
An investigational antibody‑drug conjugate being studied as a potential neoadjuvant treatment for bladder cancer. It is designed to bind to the Nectin‑4 protein on cancer cells and deliver a cell‑killing chemotherapy payload.
Also referred to as PADCEV.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if giving a cancer drug and radiation before surgery is safe and effective. It tests three different timing schedules for the treatment.
- Who it's for
- People with bladder cancer who are planning to have surgery to remove the bladder.
- What's involved
- Participants will receive a drug called enfortumab vedotin and radiation therapy. After finishing these treatments, they will have surgery as part of their normal care.
- Time commitment
- The study involves a period of drug and radiation treatment followed by surgery, but the total duration is not specified.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Urothelial carcinoma of the urinary bladder stage cT1-4a (AJCC 8th edition) N0M0 planned for radical cystectomy.
- For cR1 staged patients. the patient must have high grade disease AND be appropriate for cystectomy.
- Mixed cell types with variant histologies (including squamous, plasmacytoid, adenocarcinoma, sarcomatoid, micropapillary, nested, and lipid cell...
- Age \>=18.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
You likely can't join if
- No prior systemic therapy (except prior therapy for non-muscle invasive bladder cancer \>12 prior to registration) for bladder cancer or prior pelvic...
- Baseline \>= Grade 2 sensory or motor neuropathy
- people may not be receiving any other investigational agents for the treatment of the cancer under study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to enfortumab vedotin or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- people must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
See the full eligibility criteria
- Urothelial carcinoma of the urinary bladder stage cT1-4a (AJCC 8th edition) N0M0 planned for radical cystectomy.
- For cR1 staged patients. the patient must have high grade disease AND be appropriate for cystectomy.
- Mixed cell types with variant histologies (including squamous, plasmacytoid, adenocarcinoma, sarcomatoid, micropapillary, nested, and lipid cell variants) are allowed as long as any urothelial histology is present (i.e.
- Age \>=18.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
- Adequate organ and marrow function as defined below: Hematologic: -Absolute neutrophil count (ANC) \>=1500/mm3
- Platelet count \>=100x109/L
- Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for people with Gilbert's disease
- No end stage renal disease requiring dialysis allowed
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 8\.
- No prior systemic therapy (except prior therapy for non-muscle invasive bladder cancer \>12 prior to registration) for bladder cancer or prior pelvic radiotherapy.
- Baseline \>= Grade 2 sensory or motor neuropathy
- people may not be receiving any other investigational agents for the treatment of the cancer under study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to enfortumab vedotin or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- people must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.