The Impact of Time-of-day Administration of EV/P on Objective Response Rate in Adults With Advanced Bladder Cancer
Key facts
- Where
- Abbotsford British Columbia, Kelowna, Surrey, Vancouver, and Victoria, CanadaSee the 5 sites
- Phase
- Phase 3
Where in Canada
- BC Cancer AbbotsfordAbbotsford British Columbia, CanadaNo longer taking part
- BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)Kelowna, CanadaNo longer taking part
- BC Cancer SurreySurrey, CanadaNo longer taking part
- BC Cancer - Vancouver Cancer CentreVancouver, CanadaNo longer taking part
- BC Cancer - VictoriaVictoria, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Guliz Ozgun
- Trial code
- NCT07346053
- Record updated
- 1 October 2026
- Original description
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.Read full original descriptionShow less
CHRONO-EVP: Time-of-day Dependent Administration of Enfortumab Vedotin and Pembrolizumab (EV/P) in Advanced Bladder Cancer
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.
Inclusion: 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.
Exclusion: Participants who meet any of following exclusion criteria will not be eligible for participation in this trial:; 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; Waivers to the exclusion criteria will NOT be allowed.