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New treatment option for Urothelial Carcinoma
Official title A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract
ClinicalTrials.gov ID: NCT05868265
What this study is testing
What is Enfortumab Vedotin?
Enfortumab Vedotin is an investigational medicine, being studied as a potential treatment for urothelial carcinoma.
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
- 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.
- 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
- Histologically confirmed high grade urothelial carcinoma of the upper tract and/or radiographically visible tumor stage T2-T4a N0/x M0 disease with...
- Patients who are o Ineligible for cisplatin based on any of the following criteria:
- 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
You likely can't join if
- Presence of metastatic disease.
- Prior treatment with systemic chemotherapy or radiotherapy for urothelial cancer of the bladder within the last 2 years. (Prior intravesical...
- 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...
- Patients with uncontrolled diabetes. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to \<8% with associated diabetes...
- Unstable angina.
See the full eligibility criteria
- 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...
- Patients who are o Ineligible for cisplatin based on any of the following criteria:
- 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...
- 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...
- If patients are HIV (+) they are eligible as long as they have: cd4 \>200, undetectable viral load and on HAART therapy.
- 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...
- 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 people 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...
- 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
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- Uniondale, New York, 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 - 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?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.