Clinical Trial

The Impact of Time-of-day Administration of EV/P on Objective Response Rate in Adults With Advanced Bladder Cancer

Study acronym: Chrono-EVP
Not Yet Recruiting Phase 3
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Summary
The goal of this clinical trial is to learn if the timing of treatments plays a role in how effective the standard-of-care drugs enfortumab vedotin and pembrolizumab (EV/P) works to treat adults with advanced bladder cancer. The trial will also learn if time-of-day reduces EV/P side-effects. Researchers will compare EV/P given in the morning (before 11:30am) vs in the afternoon (after 1:30pm), to see if circadian rhythm effects how EV/P works to treat advanced bladder cancer. Participants will be randomized in Arm A or Arm B to receive drugs EV/P either in the morning (Arm A) or afternoon (Arm B) as part of their standard-of-care treatment for advanced bladder cancer. Participants will: * Visit the clinic either in the morning (Arm A) or afternoon (Arm B) to receive EV/P treatment as part of their regular medical care for advanced bladder cancer * Frequency of visits will follow standard-of-care guidelines * Participants will be followed-up by the study team for up to 24 months.
Trial Details
NCT Number NCT07346053
Lead Sponsor Guliz Ozgun
Collaborators: British Columbia Cancer Agency
Conditions Advanced Bladder Cancer
Enrollment 224 participants
Start Date 2026-05
Primary Completion 2030-12 (estimated)
Study Completion 2032-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-16