Clinical trial for Urothelial Cancer
Official title Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
ClinicalTrials.gov ID: NCT07566156
What this study is testing
What is Enfortumab vedotin?
This is an investigational medicine being studied as a potential treatment for muscle-invasive bladder cancer. It is designed to attach to a specific protein on the surface of cancer cells and deliver a toxic payload directly into them.
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 is testing whether two drugs work together to treat bladder cancer. It compares this new mix to the standard treatment of chemo and radiation.
- Who it's for
- You may be able to join if you have bladder cancer that has not spread outside the bladder.
- What's involved
- You would get either two new drugs or the standard chemo and radiation. You would also have regular check-ups and tests to see how you are doing.
- Time commitment
- The study lasts for a set time with regular visits to the clinic for care and tests.
- Phase 3: a large, late-stage study
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
- Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0
- Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline
- Eligible for and agree to receive chemoradiotherapy and one of the protocol-specified radiosensitizing chemotherapy regimens
- Fit for systemic therapy and elect bladder preservation, including participants who are ineligible for or have elected not to undergo cystectomy
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
You likely can't join if
- Advanced or metastatic disease (N+, M1), non-urothelial carcinoma, diffuse or multifocal CIS, urothelial carcinoma or histological variant at any...
- Has received any prior systemic treatment, chemoradiation, and/or radiation for MIBC or NMIBC
- Prior pelvic radiation for any reason
- Inadequate bladder function
- Other active malignancies within 3 years prior to randomization
- Previously treated with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs)
See the full eligibility criteria
- Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0
- Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline
- Eligible for and agree to receive chemoradiotherapy and one of the protocol-specified radiosensitizing chemotherapy regimens
- Fit for systemic therapy and elect bladder preservation, including participants who are ineligible for or have elected not to undergo cystectomy
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Advanced or metastatic disease (N+, M1), non-urothelial carcinoma, diffuse or multifocal CIS, urothelial carcinoma or histological variant at any site outside the urinary bladder within previous 24 months prior to...
- Has received any prior systemic treatment, chemoradiation, and/or radiation for MIBC or NMIBC
- Prior pelvic radiation for any reason
- Inadequate bladder function
- Other active malignancies within 3 years prior to randomization
- Previously treated with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs)
- Previously treated with a PD(L)-1 inhibitor, defined as a PD-1 inhibitor or PD-L1 inhibitor
- Uncontrolled diabetes
- Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted
- Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection
- Received major surgery (defined as requiring general anesthesia and \>24 hour inpatient hospitalization) within 4 weeks prior to randomization
- Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin
- Known genetic disorders associated with radiosensitivity (eg, ataxia telangiectasia, Nijmegen breakage syndrome, Fanconi syndrome)
- Active keratitis or corneal ulcerations
- History of autoimmune disease that has required systemic treatment in the past 2 years
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Prior allogeneic stem cell or solid organ transplant
- Received a live attenuated vaccine within 30 days prior to randomization
The study team makes the final eligibility decision.
Where it is enrolling
- Little Rock, Arkansas, United States
- Santa Barbara, California, United States
- Aurora, Colorado, United States
- Newark, Delaware, United States
- Hinsdale, Illinois, United States
- New Lenox, Illinois, United States
- Niles, Illinois, United States
- Fort Wayne, Indiana, United States
- Royal Oak, Michigan, United States
- Columbia, Missouri, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- Fairfield, Ohio, United States
- Eugene, Oregon, United States
- Tigard, Oregon, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Tyler, Texas, United States
- Charlottesville, Virginia, United States
+ 7 more site(s).
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 Little Rock, Arkansas, United States; Santa Barbara, California, United States; Aurora, Colorado, United States; Newark, Delaware, United States; Hinsdale, Illinois, United States; New Lenox, Illinois, United States and 21 more locations. 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.