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.

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Who may participate

 

The C4661001 study may be an option for you if:

  • You are 18 years of age or older
  • You have a diagnosis of BCG*-relapsed or BCG-unresponsive NMIBC, or recurrent intermediate-risk NMIBC
  • You are not receiving any other anti-cancer therapies
  • You have not received radiotherapy for your bladder cancer

There are other requirements for participation in the study; the study doctor will be able to explain these to you.

*Bacillus Calmette Guerin

Condition

Non-muscle invasive bladder cancer

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age

18+ years

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

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.

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What to expect

If you choose to participate, you will undergo a screening process to ensure the study is right for you. This screening period may last up to 28 days.

If you qualify and choose to join the C4661001 study, you can expect to receive up to 25 4-week cycles of study treatment with the study drug, or a combination of study drugs. The two medicines work differently, and we are investigating how effective they may be together. We will explain to you whether you will receive one or two study drugs if you decide that the study is right for you.

You should expect to make up to approximately 35 visits to the study center across a period of about 2 years. Each appointment may take a few hours.

Length of study treatment

2 years

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

Up to approx. 35

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Long-term follow up

3 years

Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.

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.

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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.

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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.

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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.

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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. 

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