Actively Recruiting
A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-12
24
Participants Needed
8
Research Sites
208 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
A
Astellas Pharma US, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to find out whether the study drug, enfortumab vedotin, is an effective and safe treatment for people who have urothelial carcinoma of the upper urinary tract. Study participants will be people who are not eligible to receive or have chosen not to receive the chemotherapy drug cisplatin for treatment of their cancer. In addition, all participants will be planning on having standard surgery to remove their tumor.
CONDITIONS
Official Title
A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed high-grade urothelial carcinoma of the upper urinary tract with tumor stage T2-T4a N0/x M0 and positive selective urinary cytology
- Ineligible for cisplatin chemotherapy due to creatinine clearance between 30 and 60 ml/min, grade 2 or higher hearing loss, or patient declined cisplatin treatment
- Availability of tumor specimen block or at least 30 unstained slides from diagnosis
- Karnofsky performance status of 70% or higher
- Medically suitable candidate for radical surgery such as nephroureterectomy, nephrectomy, or ureterectomy
- Age 18 years or older
- Laboratory values meeting specific thresholds: absolute neutrophil count ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, bilirubin ≤ 1.5 times upper limit of normal, AST and ALT ≤ 2.5 times upper limit of normal, and coagulation parameters within specified limits
- If HIV positive, must have CD4 count > 200, undetectable viral load, and be on HAART therapy
You will not qualify if you...
- Presence of metastatic disease
- Prior systemic chemotherapy or radiotherapy for urothelial cancer of the bladder within the last 2 years (prior intravesical treatment allowed)
- Grade 2 or higher peripheral neuropathy
- Active keratitis or corneal ulcerations (superficial punctate keratitis allowed if adequately treated)
- Uncontrolled diabetes with HbA1c ≥ 8% or HbA1c 7% to <8% with symptoms
- Unstable angina
- New York Heart Association Grade II or greater congestive heart failure
- History of myocardial infarction or stroke within 6 months
- Bleeding disorders or coagulopathy unless on stable therapeutic anticoagulation
- Major surgery within 28 days prior to study (except transurethral resection of bladder tumor)
- Serious non-healing wounds, ulcers, or bone fractures
- Active tuberculosis
- Other active malignancies within the past 2 years except certain treated early-stage cancers
- Prior treatment with enfortumab vedotin or similar antibody-drug conjugates
- Active hepatitis B or hepatitis C infection
- Pregnant or breastfeeding women
- Severe hypersensitivity to enfortumab vedotin or its components
- Male subjects unwilling to use contraception during and after treatment
- Women of childbearing potential not using acceptable contraception during and after treatment
- Subjects compulsorily detained for psychiatric or physical illness
- Inability to comply with study and follow-up procedures
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
University of Rochester Medical Center (Data Collection Only)
Rochester, New York, United States, 14642
Actively Recruiting
8
Memorial Sloan Kettering Nassau (Limited protocol activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
S
Scot Niglio, MD, MS
CONTACT
J
Jonathan Rosenberg, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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