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Enfortumab Vedotin for Upper Urinary Tract Urothelial Carcinoma

This study is looking at whether enfortumab vedotin is a safe and effective treatment for people with urothelial carcinoma (a type of cancer) in the upper urinary tract. You may be eligible if you have high-grade urothelial carcinoma that is T2-T4a N0/x M0 stage and are not able to receive or have chosen not to receive cisplatin chemotherapy. All participants will also be planning to have surgery to remove their tumor. The study will measure success by seeing how many patients have a complete response to the treatment, meaning no signs of cancer are found after surgery. The current status of this study is unclear.

Study design
This study is interventional and plans to enroll 9 participants. All participants will receive the same treatment.
What's involved
You will receive enfortumab vedotin on days 1 and 8 of a 21-day cycle, for a total of three cycles. Radical surgery to remove the tumor will take place within 60 days after your last dose of treatment.
Compensation
Not stated in the trial record.
Follow-up
The study will measure your response to treatment for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05868265

A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~9 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Enfortumab VedotinRadical surgery

At a glance

Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients who achieve pathologic complete response
Measured over up to 2 years

Conditions

Urothelial Carcinoma

Explore related trials

Urothelial Carcinoma

Where it's being run

8 sites across 2 states
New York5
New Jersey3

Study leadership

  • Scot Niglio, MD, MS · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically confirmed high grade urothelial carcinoma of the upper tract and/or radiographically visible tumor stage T2-T4a N0/x M0 disease with positive selective urinary cytology. Hydronephrosis associated with tumor on imaging or biopsy will be considered invasive by definition. (Variant histology is acceptable if there is a predominant urothelial component. Discussion with PI strongly encouraged.) Retroperitoneal lymph nodes \<15 mm in the short axis will be eligible.
Patients who are
Estimated or calculated creatinine clearance ≥ 30ml/min but \< 60 ml/min
Grade 2 or above audiometric hearing loss (per CTCAE v5.0) or
Declined cisplatin-based neoadjuvant chemotherapy, as documented in medical chart
Availability of tumor specimen block, cell block or 30 unstained slides from diagnosis. Patients with fewer than 30 slides available may be enrolled after discussion with the Principal Investigator.Additional research biopsy is not required.
Karnofsky performance status ≥ 70%.
Medically appropriate candidate for radical surgery (nephroureterectomy, nephrectomy, or ureterectomy), as per treating Attending Urologic Oncologist
Age ≥ 18 years.
Required initial laboratory values:
Absolute neutrophil count ≥ 1.5 x 10\^9 /L
Platelets ≥ 100 x 109 /L
Bilirubin ≤1.5 times the upper limit of normal (x ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN PTT/PT ≤1.5 x ULN or INR \< 1.7 x ULN for patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose
If patients are HIV (+) they are eligible as long as they have: cd4 \>200, undetectable viral load and on HAART therapy.

Exclusion

Presence of metastatic disease.
Prior treatment with systemic chemotherapy or radiotherapy for urothelial cancer of the bladder within the last 2 years. (Prior intravesical treatment such as BCG is allowed).
Grade 2 or higher peripheral neuropathy.
Patients with active keratitis or corneal ulcerations. Patients with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator.
Patients with uncontrolled diabetes. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to \<8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
Unstable angina.
New York Heart Association (NYHA) Grade II or greater congestive heart failure.
History of myocardial infarction within 6 months.
History of stroke within 6 months.
Evidence of bleeding diathesis or coagulopathy. Therapeutic anticoagulation is permitted, but patients must be on a stable dose.
Major surgical procedure within 28 days prior to the study. (Transurethral resection of bladder tumor is permitted)
Serious, non-healing wound, ulcer, or bone fracture.
Patients with active tuberculosis.
Other prior malignancy active within the previous 2 years except for local or organ confined early stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study.
Prior treatment with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs).
No known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
Women who are breastfeeding or pregnant as evidenced by a positive pregnancy test within 14 days of first dose.
Known severe (≥ Grade 3) hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate, and polysorbate 20).
Male subjects who are unwilling to use contraception during the treatment and for at least 31 weeks after the last dose of study treatment (5 half-lives of study drug plus 90 days duration of sperm turnover).
Women of childbearing potential (WOCBP) not using a medically acceptable means of contraception throughout the study treatment and for at least 23 weeks following the last dose of study treatment (5 half-lives of study drug plus 30 days duration of ovulatory cycle).
Amenorrhea ≥ 12 consecutive months without another cause, or
For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
Inability to comply with study and/or follow-up procedures.

What this trial measures

  • Proportion of patients who achieve pathologic complete responseup to 2 years

    The absence of residual disease on pathologic evaluation on surgical specimen following neoadjuvant enfortumab vedotin for UTUC. Pathologists will assess surgical specimens systematically using criteria agreed upon for all conventional neoadjuvant treatment based on the AJCC TNM staging system.