NCT05259397
A phase 1 clinical trial investigating a potential treatment option for people with non-muscle invasive bladder cancer (NMIBC).
The study drug will be given either by itself or in combination with another study drug. The two medicines work differently, and we are investigating how effective they may be together.
Clinical research plays an essential role in our understanding of diseases like NMIBC, and helps us learn more about potential treatment options.
We know that considering whether to take part in a clinical trial is a big decision, and we will be here to support you at all times.
Who may participate
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
NMIBC and BCG
The current standard of care following surgery is immunotherapy with the Bacillus Camille Guerin (BCG) vaccine. This treatment recommendation has not changed for the past 30 years1 and it remains effective in around half of those who receive the therapy.2
The C4661001 study aims to explore potential treatment options for people for whom therapy with the BCG vaccine is not effective.
References: 1. Bellmunt J et al. Cancer Treat Rev 2017; 54: 58-67. 2. Gual Frau J et al. Arch Esp Urol 2016; 69(7): 423-33.
Why participate?
While there is no absolute guarantee that you will receive any benefit from the study drug, you will be helping to advance medical knowledge of NMIBC and will receive lots of support from the expert medical team throughout the study.
Frequently asked questions
Is taking part in this clinical trial voluntary?
Yes, participation in clinical trials is completely voluntary: taking part in a trial is your choice. You are free to stop being in this trial at any time and for any reason and it will not affect your future medical care in any way.
Why do we need clinical trials?
Clinical trials are important to understand more about potential treatment options for all sorts of conditions. Clinical research studies also help us learn more about the side effects of a potential treatment and to understand whether the possible benefits outweigh the risks.
Are there any risks?
There are some risks associated with taking any medication, and the study medicines are no different. It is possible your condition or health may improve, worsen, or stay the same. If your health gets worse, the study team and the study doctor will help you decide what to do, which may mean stopping your participation in the study.
Participant safety is the top priority of this clinical trial. Before you participate, you will be provided with an informed consent document that explains the potential risks and benefits in detail. Your health will also be monitored by the study team while in the study.
Are there any benefits?
Participation may help people in the future by increasing our understanding of the investigational or study medicines and NMIBC, but there may be no direct benefit to you.
What is Informed Consent?
Informed consent is one of the most important tools to help you understand how your rights, safety, and well-being will be addressed throughout the trial.
During informed consent, you will be given all details about the study, including potential benefits and risks of taking part.
