Actively Recruiting
Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)
Led by M.D. Anderson Cancer Center · Updated on 2026-03-02
41
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if the combination of enfortumab vedotin plus radiation therapy could help to control the disease.
CONDITIONS
Official Title
Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)
Who Can Participate
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 informed consent
- ECOG performance status of 0 to 2 (ambulatory, including wheelchair mobility if unable to walk due to paralysis)
- Baseline lab values: hemoglobin 6 9 g/dL, platelet count 6 100 x 10^9/L, creatinine clearance 6 30 mL/min or equivalent, absolute neutrophil count 6 1500/mm3
- Male participants must use highly effective birth control from screening through 6 months post-radiation
- Female participants must use highly effective birth control from screening through 6 months post-radiation
- Candidate for definitive local therapy to active disease as determined by treating physicians
You will not qualify if you...
- Diagnosis of active scleroderma, lupus, ulcerative colitis, or other rheumatologic disease preventing safe radiation therapy
- Known psychiatric or substance abuse disorders interfering with trial participation
- Distant metastatic disease beyond lymph node metastases untreatable by radiation
- Prior pelvic radiation therapy
- Ongoing clinically significant toxicity (Grade 2 or higher except alopecia) from prior systemic therapy
- Uncontrolled diabetes mellitus within 3 months (HbA1c 6 8% or 7-<8% with symptoms)
- Life expectancy less than 12 weeks
- Preexisting sensory or motor neuropathy Grade 6 2
- Receiving systemic intravenous antimicrobial treatment for active infection at randomization
- Known hepatitis B or active hepatitis C infection
- Known HIV infection
- Use of high-dose steroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medications, except inhaled/topical steroids without autoimmune disease or physiologic corticosteroid replacement
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or active pneumonitis on chest CT
- Prior allogeneic stem cell or solid organ transplant
- Active tuberculosis
- Pregnant or planning to conceive during the study; females of childbearing potential must have a negative pregnancy test within 6 weeks prior to registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Comron Hassanzadeh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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