Actively Recruiting
Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer
Led by Emory University · Updated on 2026-04-29
32
Participants Needed
1
Research Sites
386 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/Ib trial seeks to find out the best dose, possible benefits and/or side effects of cabozantinib in combination with enfortumab vedotin in treating urothelial cancer that has spread to nearby tissues and lymph nodes (locally advanced) or other parts of the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to a toxic agent called vedotin. Enfortumab attaches to nectin-4 tumor cells in a targeted way and delivers vedotin to kill them. Cabozantinib in combination with enfortumab vedotin may be safe and effective in treating locally advanced or metastatic urothelial cancer.
CONDITIONS
Official Title
Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed urothelial carcinoma, including squamous or mixed types
- Metastatic disease or unresectable locally advanced disease
- Prior treatment with a checkpoint inhibitor (PD-1 or PD-L1 inhibitor)
- Prior platinum-containing chemotherapy or ineligible for it at enrollment
- Recovery to baseline or grade 1 or less adverse events from prior treatments
- Available tumor tissue samples or willingness to undergo repeat biopsy
- Measurable disease by RECIST version 1.1
- ECOG performance status of 0, 1, or 2
- 18 years of age or older
- Adequate blood counts and organ function within 28 days before first dose
- Ability to understand and comply with study requirements and signed informed consent
- Agreement to use effective contraception during study and for 4 months after last dose
- Female participants of childbearing potential must not be pregnant at screening and meet menopause or sterilization criteria
You will not qualify if you...
- Prior treatment with cabozantinib
- Prior participation in enfortumab vedotin studies or treatment with MMAE-based antibody-drug conjugates
- Use of kinase inhibitors or systemic anticancer therapy within 2 weeks before first dose
- Radiation therapy within 2 weeks before first dose; radionuclide therapy within 6 weeks
- Untreated or unstable brain metastases or cranial epidural disease
- Use of certain anticoagulants not permitted; some low-dose anticoagulants allowed
- Uncontrolled significant illnesses including severe heart failure, unstable angina, serious arrhythmias, uncontrolled hypertension, recent heart attack or stroke within 6 months
- Active gastrointestinal conditions with risk of perforation or fistula
- Significant bleeding events within 12 weeks before first dose
- Pulmonary lesions with cavitation or involvement of major blood vessels
- Ongoing sensory or motor neuropathy grade 2 or higher
- Other significant medical conditions affecting safety
- Major surgery within 2 weeks or minor surgery within 10 days before first dose without full healing
- Corrected QT interval over 500 ms on ECG within 14 days before first dose
- Pregnant or breastfeeding females
- Inability to swallow tablets
- Known allergies to study treatment components
- Other active cancers requiring treatment within 3 years except certain cured skin or localized cancers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
M
Mehmet Bilen, 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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