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Enfortumab Vedotin and Radiation for Bladder Cancer

This study is testing a combination of enfortumab vedotin (a drug called PADCEV) and stereotactic radiation for people with muscle-invasive bladder cancer that has not spread. This treatment is given before surgery (radical cystectomy). The study aims to find the safest dose of enfortumab vedotin and radiation together, and to see how many people have no cancer cells left in their bladder after this treatment and before surgery. You may be eligible if you have bladder cancer that is planned for surgery and you cannot receive standard chemotherapy. The study plans to enroll 19 participants and is currently unclear on its recruitment status.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a Phase I/II trial with a safety lead-in, meaning the dose of radiation will be gradually increased to find the safest level.
What's involved
Participants will receive enfortumab vedotin intravenously (into a vein) on Day 1 and Day 8 of a 21-day cycle for three cycles. They will also receive stereotactic radiation to the bladder in 5 sessions, either after or at the same time as the enfortumab vedotin. After these treatments, all participants will have a radical cystectomy (surgery to remove the bladder).
Compensation
Not stated in the trial record.
Follow-up
The maximum tolerated dose will be measured for approximately 120 days. The rate of complete response to treatment will be measured at the time of surgery, which is approximately 6 weeks after finishing the enfortumab vedotin treatment.

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NCT06394570

Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~19 participants
Updated 2025-09-15 on ClinicalTrials.gov
What's tested:Enfortumab vedotin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD) Regimen
Measured over From initiation of Enfortuman Vedotin treatment until post neoadjuvant therapy visit (approximately 120 days)
+1 more outcome measured

Conditions

Bladder Cancer

Explore related trials

Urothelial Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Who to contact

Tian Zhang, MD, MHS
[email protected]
214-648-4180
Email the study team

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Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) \>=1500/mm3
Platelet count \>=100x109/L
Hemoglobin ≥ 9 g/dL
Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
No end stage renal disease requiring dialysis allowed 6. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months following completion of study neoadjuvant therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

What this trial measures

  • Maximum Tolerated Dose (MTD) RegimenFrom initiation of Enfortuman Vedotin treatment until post neoadjuvant therapy visit (approximately 120 days)

    A standard 3 + 3 dose escalation schedule will be used for all escalations. Enfortumab Vedotin will be given for three 21 day cycles. Radiation therapy will be administered at dose level 0, level 1 or level 2.

  • Pathologic Complete response rate at radical cystectomyAt radical cystectomy following completion of neoadjuvant therapy (approximately 6 weeks after completion of EV treatment)

    Rate of complete pathologic response in bladder tumor biopsy at cystectomy according to postsurgical staging.