RecruitingPhase 1Phase 2NCT06394570

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

Stereotactic Treatment With neoAdjuvant Radiotherapy and Enfortumab Vedotin: a Phase I/II Study With Safety Lead-In for Localized, Cisplatin Ineligible, Muscle Invasive Bladder Cancer (STAR-EV)

Sponsor

University of Texas Southwestern Medical Center

Enrollment

19 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer

Summary

STAR-EV will evaluate the combination of enfortumab vedotin plus radiotherapy (RT) as neoadjuvant treatment for muscle invasive bladder cancer prior to radical cystectomy surgery. The study will use "dose escalation" to evaluate the safety and efficacy of study treatment at three dose regimens: Level 0: EV treatment followed by RT to the bladder Level 1: EV treatment with RT starting on Cycle 2, Day 15 Level 2: EV treatment with RT starting on Cycle 1, Day 15 Following completion of EV+RT neoadjuvant therapy, all subjects will undergo surgery as part of routine care.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests combining a targeted drug called enfortumab vedotin with focused radiation therapy (stereotactic body radiation) in people with localized bladder cancer who cannot receive the standard chemotherapy drug cisplatin. **You may be eligible if...** - You have been diagnosed with muscle-invasive bladder cancer - You are not able to receive cisplatin (due to kidney problems, hearing loss, or other health reasons) - You are planning to have a radical cystectomy (bladder removal surgery) - You are at least 18 years old with adequate organ function **You may NOT be eligible if...** - You have cancer that has already spread to distant parts of the body - You have certain types of bladder cancer (such as pure small cell) - You have active autoimmune disease or are on systemic steroids - You have uncontrolled diabetes (which increases the risk of skin side effects from this drug) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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