Enfortumab Vedotin, Pembrolizumab and Quemliclustat for the Treatment of Unresectable Locally Advanced and Metastatic Urothelial Cancer

This phase Ib/II trial tests the safety, side effects, and best dose of quemliclustat in combination with enfortumab vedotin and pembrolizumab, and to see how well the combination works for the treatment of bladder, renal pelvis, or ureter urothelial cancer that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping

Trial Details

NCT ID
NCT07667335
Phase
PHASE1 / PHASE2
Sponsor
Fred Hutchinson Cancer Center
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • Quemliclustat
  • Biospecimen Collection
  • Computed Tomography
  • Enfortumab Vedotin
  • Magnetic Resonance Imaging
  • Pembrolizumab
Locations (sample)
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Participants must be at least 18 years of age on the day of signing informed consent. Participant provides written informed consent for trial
  • Participants must have previously untreated locally advanced or metastatic bladder cancer including bladder cancer \[stage IIIB: T1-T4N2-3M0, stage…
  • Participants must have either conventional urothelial carcinoma or urothelial carcinoma variants. A review of pathology by a local expert genitouri…
  • Urothelial carcinoma with squamous differentiation

For full eligibility, visit ClinicalTrials.gov.

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