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Morning or afternoon? new study tests best time for bladder cancer drugs

NCT ID NCT07346053

Symptom relief Sponsor: Guliz Ozgun Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether giving standard bladder cancer drugs in the morning or afternoon changes how well they work and how many side effects they cause. About 224 adults with advanced bladder cancer will be randomly assigned to receive their treatment either before 11:30 a.m. or after 1:30 p.m. Researchers will track tumor response and survival over 24 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
enfortumab vedotin and pembrolizumab (EV/P)
What this could lead to
If timing matters, this could make existing treatments more effective and less toxic without new drugs.
What could go wrong
This is a Phase 3 trial, but it only tests timing, not a new therapy. Results may show no difference or be hard to apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must meet all of the following inclusion criteria to be eligible for participation in this trial: 1. Age 18 or older 2. Able to provide informed consent 3. Histologically confirmed advanced urothelial cancer 4. Eligible for standard-of-care EV/P regimen 5. Measurable disease per RECIST 1.1 6. ECOG performance status 0-2 7. 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: * Participants who meet any of following exclusion criteria will not be eligible for participation in this trial: 1. Non-urothelial histology or mixed histology with predominant non-urothelial components 2. Concurrent malignancy requiring active systemic therapy, unless disease-free for at least 2 years 3. Inability to comply with protocol-specified infusion timing for at least the first 3 months 4. Night shift workers 5. Clinical evidence of new or enlarging brain metastasis or carcinomatous meningitis 6. Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial 7. 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. 8. 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.

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Conditions

The condition(s) this trial relates to.

urinary bladder cancer urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BC Cancer - Abbotsford

    Abbotsford British Columbia, British Columbia, V2S 0C2, Canada

  • BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)

    Kelowna, British Columbia, V1Y 5L3, Canada

  • BC Cancer - Surrey

    Surrey, British Columbia, V3V 1Z2, Canada

  • BC Cancer - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6, Canada

  • BC Cancer - Victoria

    Victoria, British Columbia, V8R 6V5, Canada

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