Active not recruitingPHASE3INTERVENTIONAL

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

This study is looking at a new treatment called cretostimogene for people with a type of bladder cancer that's in the lining of the bladder and hasn't responded to standard BCG therapy. This is a "Phase 3" study, which means it's one of the final steps before a treatment might become widely available. The study is open to patients with high-grade non-muscle invasive bladder cancer, including those with carcinoma in situ (CIS) or papillary disease (Ta/T1). Researchers want to see if cretostimogene can help get rid of the cancer or stop it from coming back in these patients. Different groups within the study are looking at slightly different situations of how the cancer previously didn't respond to BCG.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

CG Oncology, Inc.

Enrolment target

190

Start

27 Oct 2020

Estimated completion

24 Dec 2031

Non Muscle Invasive Bladder Cancer High-grade Ta/ T1 Papillary Disease Bladder Cancer

What is this study about?

This study is looking at a new treatment called cretostimogene for a type of bladder cancer that affects the bladder's inner lining. This type of cancer is called "non-muscle invasive bladder cancer" (NMIBC). Many people with NMIBC are treated with a medicine called BCG, which is put directly into the bladder. However, sometimes BCG doesn't work, or the cancer comes back, and that's when this new treatment might be important.

The researchers want to see how well cretostimogene works in people whose bladder cancer hasn't responded to BCG treatment. The study is divided into different groups of patients, depending on the specific type of non-muscle invasive bladder cancer they have and how their cancer previously responded (or didn't respond) to BCG. For example, some groups focus on carcinoma in situ (CIS), which is a very early but aggressive form of cancer, while others focus on papillary disease (Ta/T1).

The main goal is to find out if cretostimogene can effectively get rid of the cancer or prevent it from returning in these patients who have limited treatment options. This is a late-stage clinical trial, meaning that earlier studies have shown some promise, and now researchers need more information to understand its full potential benefits and any side effects.

Key takeaways

This study is testing a new treatment for a specific type of bladder cancer.
It's for people whose bladder cancer hasn't responded to BCG treatment.
The treatment is called cretostimogene.
It's a Phase 3 study, meaning it's a later stage of research.
Participation involves regular check-ups and receiving the study treatment.

Who may be eligible?

This study is looking for adults aged 18 or over. You would be considered if you have a specific type of bladder cancer that is only in the lining of your bladder and has been classified as "high-grade." This means it has a faster growth potential.

Crucially, your bladder cancer must not have responded to previous BCG treatment put into your bladder. This means that after getting BCG, your cancer either didn't go away or it came back within a certain timeframe (either 6 or 12 months, depending on your specific situation and the type of cancer). Your doctors would need to confirm these details using your medical records and recent scans or tests. You also need to be generally well enough to take part in the study, and your doctors would check this.

People who are not able to have a major surgery to remove their bladder (called a radical cystectomy) might also be especially suited for this study, as it explores other treatment options.

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 high-grade non-muscle invasive bladder cancer?
Has your bladder cancer not responded to previous BCG treatment?
Have you had all visible cancer removed from your bladder recently?
Are you generally well enough for this type of treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive the new treatment, cretostimogene. The study is designed to follow a set plan, and this will involve regular visits to the hospital or clinic. During these visits, the doctors will check on your health, how the treatment is affecting you, and look for any changes in your bladder cancer. This will involve various tests and examinations. The exact number and type of visits and tests would be fully explained by the study team, but generally, studies like this involve close monitoring for some time. The treatment is given directly into the bladder. The total duration of your participation would depend on how you respond to the treatment and the study's protocol, but it would involve ongoing check-ups after the main treatment phase.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. A potential benefit of this study is that cretostimogene might help treat your bladder cancer when other standard treatments, like BCG, haven't worked. You would also be closely monitored by a healthcare team throughout the study. However, there are also potential risks; the new treatment might have side effects that are not yet fully understood, and it might not work for everyone. You will receive detailed information about all known risks and side effects before you decide to take part. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (86)

Urology Centers Alabama
Verified postcode
Homewood, United States
BCG Oncology
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Phoenix, United States
Mayo Clinic Cancer Center
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Phoenix, United States
Arizona Institute of Urology
Verified postcode
Tucson, United States
Arkansas Urology
Verified postcode
Little Rock, United States
University of California - Irvine
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Irvine, United States
American Insititute of Research
Verified postcode
Los Angeles, United States
Genesis Research
Verified postcode
Sherman Oaks, United States
Genesis Research LLC
Verified postcode
Torrance, United States
University of Colorado
Verified postcode
Aurora, United States
Colorado Clinical Research
Verified postcode
Lakewood, United States
Urology Associates, Research Department
Verified postcode
Lone Tree, United States

Common questions

What is non-muscle invasive bladder cancer?

It's a type of bladder cancer that is found only in the inner lining of the bladder and hasn't spread into the muscle layer.

What does 'BCG unresponsive' mean?

It means the standard BCG treatment, which is put into the bladder, didn't work to clear your bladder cancer, or the cancer came back shortly after treatment.

What is cretostimogene?

It's a new treatment being tested in this study for certain types of bladder cancer that haven't responded to other treatments.

What is a Phase 3 trial?

It's one of the final stages of testing a new medicine, typically involving more people to confirm its effectiveness and safety before it can be approved for wider use.

Will I have to pay to be in the study?

No, you will not have to pay for the study treatment or for the extra tests and visits related to the study.