The Impact of Time-of-day Administration of EV/P on Objective Response Rate in Adults With Advanced Bladder Cancer
This study aims to discover if giving standard bladder cancer treatment (called enfortumab vedotin and pembrolizumab, or EV/P) at a specific time of day changes how effective it is. Researchers also want to see if the timing can reduce side effects. Some people think our body's natural clock (circadian rhythm) might affect how medicines work. Participants will be randomly assigned to receive their EV/P treatment either in the morning (before 11:30 am) or in the afternoon (after 1:30 pm), as part of their usual care for advanced bladder cancer. The study will then compare the results to understand the impact of treatment timing.
At a glance
What is this study about?
This research study, called 'The Impact of Time-of-day Administration of EV/P on Objective Response Rate in Adults With Advanced Bladder Cancer', is trying to answer an important question: does the time of day you receive your bladder cancer treatment affect how well it works? It specifically focuses on a common treatment combination called enfortumab vedotin and pembrolizumab, often shortened to EV/P. Researchers are also interested in whether receiving this treatment at a particular time might lead to fewer side effects.
The idea behind this study is linked to our body's natural rhythms, often called the circadian rhythm or body clock. Some scientists believe that our body's internal clock might influence how drugs are processed and how effective they are. By giving the same treatment at different times of the day (morning versus afternoon), the study aims to see if this natural rhythm plays a role in the success of EV/P for advanced bladder cancer.
Ultimately, the goal is to find out if there's an 'optimal' time to give this treatment. If researchers discover that giving EV/P at a certain time of day leads to better results or fewer side effects, this information could help doctors make more informed decisions about when to schedule treatments for patients with advanced bladder cancer in the future.
Key takeaways
- This study explores if treatment timing affects bladder cancer therapy.
- It aims to see if morning versus afternoon treatment changes effectiveness or side effects.
- Participants will receive standard EV/P treatment.
- You will be randomly assigned to a morning or afternoon treatment group.
- The study follows participants for up to two years.
Who may be eligible?
To join this study, you must be 18 years or older and have a confirmed diagnosis of advanced bladder cancer. You should also be suitable for the standard EV/P treatment that is usually given for your condition, and your cancer needs to be measurable.
You won't be able to join if your cancer is a different type that is not mainly urothelial, or if you have another active cancer that needs treatment. People who work night shifts, have new or growing cancer in the brain, or have serious sleep disorders that aren't well controlled are also not suitable. If you've travelled across two or more time zones recently (in the last 14 days), you also wouldn't be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have advanced bladder cancer?
- Are you suitable for the standard EV/P treatment?
- Can you commit to receiving your treatment either before 11:30 am or after 1:30 pm?
- Do you have a well-managed sleep schedule (no severe, uncontrolled sleep disorders or recent jet lag)?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of two groups: either receiving your EV/P treatment in the morning (before 11:30 am) or in the afternoon (after 1:30 pm). This will be part of your usual standard care for advanced bladder cancer, meaning the treatment itself is what you would typically receive.
You'll visit the clinic for your treatment infusions according to the normal schedule for EV/P, which will be the same for both groups. The study team will then follow your progress for up to two years. This means they will keep track of how you are doing, how the treatment is working, and any side effects you might experience during this time.
Potential risks and benefits
Locations (5)
- BC Cancer - AbbotsfordVerified postcodeAbbotsford British Columbia, Canada
- BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)Verified postcodeKelowna, Canada
- BC Cancer - SurreyVerified postcodeSurrey, Canada
- BC Cancer - Vancouver Cancer CentreVerified postcodeVancouver, Canada
- BC Cancer - VictoriaVerified postcodeVictoria, Canada
Common questions
What is 'advanced bladder cancer'?
This means bladder cancer that has spread beyond the bladder or grown significantly. It requires specific treatments to manage it.
What are EV/P treatments?
EV/P stands for enfortumab vedotin and pembrolizumab. These are two medicines commonly used together to treat advanced bladder cancer.
What does 'randomly assigned' mean?
This means you will be put into a group (either morning or afternoon treatment) by chance, like flipping a coin. Neither you nor your doctor will choose the group.
Will I get different medicines if I join this study?
No, you will receive the same standard EV/P treatment you would normally get. The only difference is whether it's given in the morning or afternoon based on your assigned group.
How long will I be involved in the study?
You will receive your treatment according to your usual schedule, and the study team will follow your health and progress for up to two years.
How to find out more
Dr. Guliz Ozgun, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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