The Impact of Time-of-day Administration of EV/P on Objective Response Rate in Adults With Advanc… (NCT07346053) | Clinical Trial Compass
Not Yet RecruitingPhase 3
The Impact of Time-of-day Administration of EV/P on Objective Response Rate in Adults With Advanced Bladder Cancer
Canada224 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
What they're measuring
1
Objective response rate in in time-of-day administration of EV/P treatment
Timeframe: From enrollment to end of follow-up at 24-months.
✕. 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.