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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Participants must meet all of the following inclusion criteria to be eligible for participation in this trial:
  • Age 18 or older
  • Able to provide informed consent
  • Histologically confirmed advanced urothelial cancer
  • Eligible for standard-of-care EV/P regimen
  • Measurable disease per RECIST 1.1
  • ECOG performance status 0-2
  • Ability to adhere to scheduled infusion times (Before 11:30 a.m. or after 1:30 pm) Waivers to the inclusion criteria will NOT be allowed.

🚫 You may not be able to join if…

• Participants who meet any of following exclusion criteria will not be eligible for participation in this trial: Waivers to the exclusion criteria will NOT be allowed.
  • 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
  • Clinical evidence of new or enlarging brain metastasis or carcinomatous meningitis
  • Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
  • Patients who have traveled across ≥2 time zones within the past 14 days prior to randomization will be excluded, due to potential disruption of circadian rhythms (jet lag), which may affect chronotherapy-related endpoints.
  • Patients with a clinically diagnosed sleep disorder, including but not limited to insomnia, obstructive sleep apnea, restless leg syndrome, or circadian rhythm sleep-wake disorders, that is moderate to severe, untreated, or poorly controlled, will be excluded.

Where this trial is running

• BC Cancer - Abbotsford, Abbotsford British Columbia, British Columbia, Canada
• BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre), Kelowna, British Columbia, Canada
• BC Cancer - Surrey, Surrey, British Columbia, Canada
• BC Cancer - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
• BC Cancer - Victoria, Victoria, British Columbia, Canada

Who to contact

Dr. Guliz Ozgun, MD · 604-877-6000 · guliz.ozgun@bccancer.bc.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07346053.