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.
Age 18 or older
Able to provide informed consent
Histologically confirmed advanced urothelial cancer
Eligible for standard-of-care EV/P regimen
Non-urothelial histology or mixed histology with predominant non-urothelial components
Concurrent malignancy requiring active systemic therapy, unless disease-free for at least 2 years
Inability to comply with protocol-specified infusion timing for at least the first 3 months
Night shift workers
Guliz Ozgun
Lead sponsor
British Columbia Cancer Agency
Sponsor institution
British Columbia Cancer Agency
Collaborator