Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer

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 i

Trial Details

NCT ID
NCT04878029
Phase
PHASE1
Sponsor
Emory University
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Cabozantinib S-malate
  • Enfortumab Vedotin
  • Quality-of-Life Assessment
  • Questionnaire Administration
Locations (sample)
  • Atlanta, Georgia, United States|33.749,-84.38798

Key Eligibility Criteria

  • Histologically-documented urothelial carcinoma (squamous differentiation or mixed cell types allowed if urothelial carcinoma is present)
  • Metastatic disease or unresectable locally-advanced disease
  • Must have received prior treatment with a checkpoint inhibitor (CPI). A CPI is defined as a programmed cell death protein 1 (PD-1) or programmed de…
  • Must either have prior treatment with platinum-containing chemotherapy or be ineligible at time of enrollment

For full eligibility, visit ClinicalTrials.gov.

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