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CHRONO-EVP: Time-of-day Dependent Administration of EV/P in Advanced Bladder Cancer
NCT07346053Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2026
- Primary completion
- Dec 2030
- Countries
- 1
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes, Antibody-Drug Conjugates (ADCs)
- Conditions
- bladder cancer
01
Overview
Phase 3, randomised, open-label trial of enfortumab vedotin and pembrolizumab in bladder cancer (2 arms). Primary endpoint: Objective Response Rate at 24 months. Planned start Nov 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Arm A: Morning EV/P Treatment
Participants will receive standard-of-care therapy (EV/P) administered in the morning (before 11:30am).
Arm B: Afternoon EV/P Treatment
Participants will receive standard-of-care therapy (EV/P) administered in the afternoon (after 1:30pm).
03
Who it enrols
Adults with advanced urothelial cancer eligible for EV/P with measurable disease and ECOG 0-2, excluding those with sleep disorders, recent travel across time zones, or night shift work.
04
Endpoints
Primary
Objective Response Rate
Secondary
Progression-Free Survival
Overall Survival
Time-to-Treatment Failure
Circulating Tumor DNA Kinetics
Treatment-related tolerability and toxicity differences
Immune Profiling
Bulk RNA sequencing
Cytokine and chemokine analyses
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