Muscle-invasive Bladder Cancer study: Enfortumab Vedotin vs Pembrolizumab
Official title A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder
ClinicalTrials.gov ID: NCT07475806
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 drug 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 aims to find out how many people continue to respond well to the treatment and how many still have their bladder after 2 years.
- Who it's for
- Adults with muscle-invasive bladder cancer who are able to have surgery to remove the bladder.
- What's involved
- Participants receive infusions of enfortumab vedotin and pembrolizumab every 3 weeks, along with regular safety checks and tumor scans.
- Time commitment
- Treatment continues until the cancer changes or stops responding, followed by scans every 3 months for 2 years and every 6 months for up to 5 years.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
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
- Participant has histologically-confirmed MIBC, stage cT2-T4aN0M0 or T1-T4aN1M0.
- Participant has predominant UC histology (≥ 50%). NOTE: Participants with mixed histology are eligible provided the urothelial component is ≥ 50%...
- Participant is deemed eligible for radical cystectomy and pelvic lymph node dissection.
- Participant has accessible archival tumor tissue from the primary tumor, for which source and availability have been confirmed prior to study...
- Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
You likely can't join if
- Participant has preexisting sensory or motor neuropathy Grade ≥ 2.
- Participant has ≥ N2 disease or metastatic disease (M1) as identified by imaging
- Participant has a history of uncontrolled diabetes mellitus within 3 months prior to screening.
- Participant has a second malignancy diagnosed within 3 years before first dose of study intervention, or any evidence of residual disease from a...
- Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being...
- Participant has a history of (non-infectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
See the full eligibility criteria
- Participant has histologically-confirmed MIBC, stage cT2-T4aN0M0 or T1-T4aN1M0. NOTE: urothelial carcinomas (UCs) not originating from the bladder (e.g., upper tract [ureters, renal pelvis], urethra) are not eligible.
- Participant has predominant UC histology (≥ 50%). NOTE: Participants with mixed histology are eligible provided the urothelial component is ≥ 50% (participants whose tumors contain predominant [≥ 50%] plasmacytoid...
- Participant is deemed eligible for radical cystectomy and pelvic lymph node dissection.
- Participant has accessible archival tumor tissue from the primary tumor, for which source and availability have been confirmed prior to study intervention.
- Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Have a transurethral resection of a bladder tumor within 60 days (+14 days) prior to, or during screening (from the date of informed consent form signature).
- Participant has preexisting sensory or motor neuropathy Grade ≥ 2.
- Participant has ≥ N2 disease or metastatic disease (M1) as identified by imaging
- Participant has a history of uncontrolled diabetes mellitus within 3 months prior to screening. Uncontrolled diabetes (within 3 months before first dose) is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7% and...
- Participant has a second malignancy diagnosed within 3 years before first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
- Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being adequately treated.
- Participant has a history of (non-infectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
- Participant has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
- Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days...
- Participant has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Brief (\< 7 days) use of systemic corticosteroids is allowed when use is considered standard of care.
- Participant with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded.
- Participant requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded.
- Participant with hypothyroidism that is stable with hormone replacement therapy or Sjögren's syndrome will not be excluded.
- Participant has received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 agent or with an agent directed to another...
- Participant has received prior systemic anti-cancer therapy for MIBC/non-muscle invasive bladder cancer (NMIBC), or received prior systemic anti-cancer therapy including investigational agents (including enfortumab...
- Participant has received a partial cystectomy of the bladder to remove any NMIBC or MIBC.
- Participant has received any prior radiotherapy to the bladder.
The study team makes the final eligibility decision.
Where it is enrolling
- Little Rock, Arkansas, United States
- Orange, California, United States
- Stanford, California, United States
- Chicago, Illinois, United States
- Lisle, Illinois, United States
- Indianapolis, Indiana, United States
- Westwood, Kansas, United States
- Detroit, Michigan, United States
- Royal Oak, Michigan, United States
- Minneapolis, Minnesota, United States
- Cherry Hill, New Jersey, United States
- Washington Township, New Jersey, United States
- New York, New York, United States
- Bala-Cynwyd, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Willow Grove, Pennsylvania, United States
- Myrtle Beach, South Carolina, United States
- Houston, Texas, United States
- Round Rock, Texas, United States
- San Antonio, Texas, United States
+ 52 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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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; Orange, California, United States; Stanford, California, United States; Chicago, Illinois, United States; Lisle, Illinois, United States; Indianapolis, Indiana, United States and 66 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.