What is enfortumab vedotin studying for advanced bladder cancer?

Enfortumab vedotin is being studied in combination with radiation therapy to see if it can help control locally advanced bladder cancer. The research aims to understand progression-free survival, safety, and quality of life for participants. This study is sponsored by M.D. Anderson Cancer Center to explore new treatment options for this condition.

Who may be eligible for this advanced bladder cancer clinical trial?

Adults aged 18 years or older with a confirmed diagnosis of urothelial carcinoma of the bladder, including certain advanced stages, may be eligible. Both men and women can participate if they have a good performance status and meet lab test requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced bladder cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can plan accordingly for any additional costs related to travel or lodging.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06434350

Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer CONSOLIDATE

Led by M.D. Anderson Cancer Center · Updated on 2026-03-02

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate whether combining enfortumab vedotin with radiation therapy can help control locally advanced muscle-invasive bladder cancer MIBC. The study focuses on estimating how long participants live without disease progression, assessing safety and tolerability, and evaluating quality of life through specific health surveys. Secondary goals include measuring overall survival, metastasis-free survival, treatment-related toxicities, and urinary tract event freedom within 12 months after enrollment, along with exploring biomarkers in blood and urine related to participant outcomes. Participants will receive enfortumab vedotin intravenously over 1 to 2 hours on Days 1 and 8 of each 28-day cycle, with two dose levels tested depending on when they join the study. Alongside this, radiation therapy is delivered five days a week Monday through Friday for about 4 to 5 weeks as part of definitive local therapy. The dosing and treatment schedule are carefully monitored throughout the study. During the study, participants will be closely assessed for safety and adverse events over approximately one year. Researchers will monitor health-related quality of life using surveys and track treatment-related toxicities and survival outcomes. Laboratory tests and biomarker analyses will be conducted to better understand responses. The total participation time includes treatment and follow-up visits to ensure comprehensive evaluation of the combined therapys impact and safety.

CONDITIONS

Brief Title

Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Pathologically confirmed urothelial carcinoma of the bladder, including T4N0 and T1-4N2-3 disease or mixed urothelial carcinoma.
Age 18 years or older at the time of informed consent.
ECOG performance status of 0 to 2, ambulatory or mobile with wheelchair.
Laboratory values: Hemoglobin ≥ 9 g/dL, Platelet count ≥ 100 x 10^9/L, Creatinine clearance ≥ 30 mL/min, Absolute neutrophil count ≥ 1500/mm3.
Male and female participants must use highly effective birth control from screening through 6 months after radiation.
Candidate for definitive local therapy to active disease as determined by treating physicians.

You will not qualify if you...

Active scleroderma, lupus, ulcerative colitis, or other rheumatologic diseases precluding safe radiation therapy.
Known psychiatric or substance abuse disorders interfering with trial cooperation.
Distant metastatic disease beyond treatable lymph node metastases.
History of prior pelvic radiation therapy.
Ongoing clinically significant toxicity (Grade 2 or higher, except alopecia) from prior systemic therapy.
Uncontrolled diabetes mellitus within 3 months before enrollment (HbA1c ≥ 8% or 7-<8% with symptoms).
Estimated life expectancy less than 12 weeks.
Preexisting sensory or motor neuropathy Grade 2 or higher.
Receiving ongoing systemic intravenous antimicrobial treatment for active infection.
Known history of hepatitis B or active hepatitis C infection.
Known history of HIV infection.
Use of high-dose steroids (>10 mg/day prednisone or equivalent) or immunosuppressive medications.
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or idiopathic pneumonitis, or active pneumonitis on chest CT.
Prior allogeneic stem cell or solid organ transplant.
Active tuberculosis.
Pregnant or expecting to conceive during the trial; females must have negative pregnancy test before registration.

Research Team

Comron Hassanzadeh, MD

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