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Active not recruitingPHASE3INTERVENTIONAL

A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

This research study is for people with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC) that is considered intermediate risk. This means the cancer has not grown into the bladder muscle, and your doctor thinks it has a moderate chance of coming back. All participants will have surgery to remove the visible cancer. Half will then receive a new treatment called cretostimogene grenadenorepvec, given into the bladder, and half will be closely monitored. Doctors want to see if the new treatment can help prevent the cancer from returning compared to just monitoring. The study will track how well the treatments work and how safe they are.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
CG Oncology, Inc.
Enrolment target
367
Start
14 Dec 2023
Estimated completion
01 Feb 2029

What is this study about?

This study is about a kind of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This means the cancer is only on the lining of the bladder and hasn't grown deeper into the muscle. If you have this type of cancer, doctors usually remove it with an operation called a TURBT. Even after surgery, this type of cancer can sometimes come back.

This study is looking at a new treatment called cretostimogene grenadenorepvec. It's a type of gene therapy designed to fight cancer cells. The study wants to find out if giving this new treatment after your surgery can stop the cancer from returning for longer compared to just keeping a close eye on you. They are focusing on patients whose cancer is considered 'intermediate risk', meaning it has a moderate chance of coming back.

By comparing these two approaches, researchers hope to see if cretostimogene grenadenorepvec could become a better way to treat this type of bladder cancer after surgery. This could potentially reduce the number of times patients need further treatments or operations in the future.

Key takeaways

  • This study is for intermediate-risk non-muscle invasive bladder cancer (NMIBC).
  • It compares a new treatment (cretostimogene grenadenorepvec) to watchful waiting after surgery.
  • The new treatment is given into the bladder to try and stop cancer recurrence.
  • Participation involves surgery, regular checks, and potentially the new treatment.
  • You have a 50/50 chance of getting the new treatment or being monitored.
  • The study aims to find a better way to prevent bladder cancer from returning.

Who may be eligible?

To join this study, you would need to have a specific type of bladder cancer called intermediate-risk non-muscle invasive bladder cancer (NMIBC). This means the cancer is only on the lining of your bladder and has certain features that put it at a moderate risk of coming back. You must have had surgery to remove all visible cancer within 90 days before joining the study, and your body's organs need to be working well.

You would not be able to join if your bladder cancer has grown into the muscle, has spread to other parts of your body, or is considered either very high risk or very low risk. Also, if you've had cancer in your prostate tube, or in the upper parts of your urinary system recently, or have received similar gene therapy treatments before, you 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.

  1. Have I been diagnosed with intermediate-risk NMIBC?
  2. Has all my visible cancer been removed by surgery (TURBT) in the last 90 days?
  3. Am I at least 18 years old?
  4. Do my other body organs (like kidneys, liver) generally work well?
  5. Have I NOT had muscle-invasive, metastatic, or very high/low risk bladder cancer?
  6. Have I NOT received similar gene therapy treatments before?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have a surgical procedure called TURBT to remove your bladder cancer. Then, you would be randomly assigned to one of two groups, like flipping a coin. One group will receive the study treatment, cretostimogene grenadenorepvec, given directly into your bladder. This will start with an initial course, followed by maintenance treatments every three months for over a year, as long as your cancer hasn't returned. The other group will be closely monitored directly after your TURBT.

Regardless of your group, your医生 will regularly check for any cancer recurrence. This will involve checking your urine, looking inside your bladder with a camera (cystoscopy), and sometimes taking biopsies. These checks will happen every three months for the first two years, then every six months for another year. You'll also have scans, like a CT or MRI, every 12 months. If you are in the monitoring group and your cancer does return, you might then be offered the cretostimogene treatment. The total duration of active follow-up for the study could be several years.

Potential risks and benefits

Taking part in any clinical trial has potential advantages and disadvantages. A potential benefit of this study is that you might receive a new treatment that could help stop your bladder cancer from coming back for longer. However, the new treatment also carries potential risks, including side effects that are not yet fully known or understood. You would also need to attend many clinic visits and have several tests. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (95)

  • Urology Centers of Alabama PC
    Verified postcode
    Homewood, United States
  • Banner MD Anderson Cancer Center
    Verified postcode
    Gilbert, United States
  • Mayo Clinic
    Verified postcode
    Scottsdale, United States
  • Arizona Institute of Urology PLLC
    Verified postcode
    Tucson, United States
  • Arkansas Urology PA
    Verified postcode
    Little Rock, United States
  • Michael G. Oefelein MD Clinical Trials
    Verified postcode
    Bakersfield, United States
  • USC/Keck Department of Urology
    Verified postcode
    Los Angeles, United States
  • Tower Urology
    Verified postcode
    Los Angeles, United States
  • Sun Kim Urology
    Verified postcode
    Orange, United States
  • University of California Irvine Medical Center (UCIMC)
    Verified postcode
    Orange, United States
  • University of California Davis Cancer Center
    Verified postcode
    Sacramento, United States
  • Stanford University School of Medicine
    Verified postcode
    Stanford, United States

Common questions

What is NMIBC?

NMIBC stands for Non-Muscle Invasive Bladder Cancer. This means the cancer is only on the inner lining of your bladder and hasn't grown into the muscle layer.

What does 'intermediate risk' mean?

Intermediate risk means your doctor thinks your bladder cancer has a moderate chance of coming back after surgery, based on its specific features.

What is TURBT?

TURBT is an operation (Transurethral Resection of Bladder Tumour) where a surgeon removes the visible bladder cancer using a special instrument passed through your urethra.

What is cretostimogene grenadenorepvec?

It's a new, investigational treatment being tested in this study. It's a type of gene therapy designed to target and fight cancer cells.

Will I definitely get the new treatment if I join?

No, because it's a 'randomised' study, you have a 50/50 chance of either receiving the new treatment or being closely monitored after your surgery.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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