Clinical trial for Bladder Cancer
Official title Risk-Enabled Therapy After Initiating EV/Pembro for Bladder Cancer
ClinicalTrials.gov ID: NCT07908979
What this study is testing
What is Enfortumab vedotin?
This is an investigational medicine being studied as a potential treatment for bladder cancer. It is designed to attach to a specific protein on the surface of cancer cells and deliver a drug directly into them to help stop their growth.
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 giving enfortumab vedotin and pembrolizumab before surgery helps control bladder cancer.
- Who it's for
- You may be able to join if you have muscle‑invasive bladder cancer that has not spread to lymph nodes or other organs.
- What's involved
- You would receive two medicines before surgery, then doctors will check your cancer and blood to decide next steps.
- Time commitment
- The study lasts about a few weeks before surgery, with a few visits for blood tests and scans.
- 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
- Primary urothelial or predominantly urothelial carcinoma of the bladder confirmed from pathology report.
- Urothelial carcinoma of the prostatic urethra in men is allowed
- Histologic evidence of muscularis propria invasion.
- AJCC(22) clinical stage T2-T3 N0M0.
- No radiographic evidence of lymph node positive disease as per RECIST 1.1 (≥15 mm short axis diameter).
You likely can't join if
- Any component of small cell histology.
- Prior systemic chemotherapy for muscle-invasive urothelial cancer of the bladder.
- Uncontrolled diabetes (HbA1c \>8.5%)
- Pre-existing sensory or motor neuropathy grade \> 2
- Has a known additional malignancy that has had progression or has required active treatments in the last two years except for locally curable cancers...
- Patients who have received experimental agents within 4 weeks of study entry.
See the full eligibility criteria
- Primary urothelial or predominantly urothelial carcinoma of the bladder confirmed from pathology report. Patients with some component of variant histology mixed with predominant urothelial carcinoma will be allowed.
- Urothelial carcinoma of the prostatic urethra in men is allowed
- Histologic evidence of muscularis propria invasion.
- AJCC(22) clinical stage T2-T3 N0M0.
- No radiographic evidence of lymph node positive disease as per RECIST 1.1 (≥15 mm short axis diameter). If a lymph node is greater than 1.5 cm, it must be biopsy proven negative for the patient to be eligible.
- No metastatic disease (M0).
- ECOG performance status 0, or 1.
- Negative pregnancy test in women of child bearing potential within 72 hours of the first dose of study treatment.
- Normal organ and bone marrow function
- Any component of small cell histology.
- Prior systemic chemotherapy for muscle-invasive urothelial cancer of the bladder.
- Uncontrolled diabetes (HbA1c \>8.5%)
- Pre-existing sensory or motor neuropathy grade \> 2
- Has a known additional malignancy that has had progression or has required active treatments in the last two years except for locally curable cancers that have been apparently cured.
- Patients who have received experimental agents within 4 weeks of study entry.
- Patients who have received enfortumab vedotin based treatment in the past.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined by current oral or intravenous antibiotic therapy), symptomatic congestive heart failure, unstable angina pectoris...
- Pregnant women are excluded from this study due to the potential for teratogenic or abortifacient effects of cytotoxic therapy.
- HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load are eligible
- Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 7 days prior to first dose of study drug.
- History of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis...
- Prior treatment with CD137 agonists, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents. Has had an allogenic tissue/solid organ transplant.
- Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment.
- Allergy to EV, pembrolizumab or any excipient in the products
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, 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 Philadelphia, Pennsylvania, 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.