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

Sponsor
Guliz Ozgun
Study ID
NCT07346053
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Advanced Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • enfortumab vedotin and pembrolizumab (EV/P) — DRUG
    Participants will receive EV/P as part of their standard-of-care therapy administered either in the morning (Arm A) or afternoon (Arm B), as determined by randomization.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2032

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: Morning EV/P Treatment
    Participants will receive standard-of-care therapy (Ev/P) administered in the morning (before 11:30am).
  • Active Comparator: Arm B: Afternoon EV/P Treatment
    Participants will receive standard-of-care therapy (EV/P) administered in the afternoon (after 1:30pm).

Primary Outcome Measure

Objective response rate in in time-of-day administration of EV/P treatment [ Time Frame: From enrollment to end of follow-up at 24-months. ]

Central Contacts

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