NCT07346053Not yet recruitingPhase 3
The Impact of Time-of-day Administration of EV/P on Objective Response Rate in Adults With Advanced Bladder Cancer
CHRONO-EVP: Time-of-day Dependent Administration of Enfortumab Vedotin and Pembrolizumab (EV/P) in Advanced Bladder Cancer
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 224 (estimated)
- First submitted
- 8 Dec 2025
- Start date
- Nov 2026
- Primary completion date
- Dec 2030
- Lead sponsor
- Guliz Ozgun
- Diseases
- Bladder cancer
- NCT number
- NCT07346053
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 224
- From Nov 2026 to the primary completion date, Dec 2030
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BC Cancer Abbotsford Coordinator of this site? Confirm its status | Abbotsford British Columbia | Canada | Unknown status |
| BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre) Coordinator of this site? Confirm its status | Kelowna | Canada | Unknown status |
| BC Cancer Surrey Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
| BC Cancer - Vancouver Cancer Centre Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| BC Cancer - Victoria Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.