All studies
Active not recruitingPHASE3INTERVENTIONAL

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

This study is for people in the UK with muscle-invasive bladder cancer, a type of bladder cancer that has grown into the muscle layer. Researchers are testing a new treatment plan involving a drug called Durvalumab. Patients will receive Durvalumab combined with chemotherapy (Gemcitabine and Cisplatin) before surgery, and then Durvalumab alone after surgery. The main goal is to find out if this treatment approach is both effective and safe. This includes looking at how well the new treatment works compared to current methods and any potential side effects. The study helps doctors understand if this combination could offer a better chance for recovery.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
1,063
Start
16 Nov 2018
Estimated completion
30 Jun 2026

What is this study about?

This study is exploring a new treatment strategy for a type of bladder cancer called muscle-invasive bladder cancer. This means the cancer has grown into the muscular wall of the bladder. The current standard treatment often involves surgery, but doctors are always looking for ways to make treatments more effective and improve patient well-being.

In this trial, patients will receive a drug called Durvalumab. Durvalumab is a type of immunotherapy, which works by helping your own immune system fight cancer cells. This drug will be given alongside standard chemotherapy drugs, Gemcitabine and Cisplatin, before surgery. After surgery, patients will continue to receive Durvalumab alone. The hope is that this combination treatment, given before and after surgery, can reduce the chance of the cancer coming back.

The main purpose of this research is to see if this new treatment approach is better than what's currently available, both in terms of how well it works and whether it's safe for patients. By taking part, you would be helping medical science learn more about treating this type of cancer, potentially leading to improved options for future patients.

Key takeaways

  • Exploring a new treatment combining immunotherapy and chemotherapy for bladder cancer.
  • Specifically for muscle-invasive bladder cancer.
  • Treatment given before and after surgery.
  • Aims to improve treatment effectiveness and safety.
  • Involves regular hospital visits for monitoring.

Who may be eligible?

To be considered for this study, you would need to have muscle-invasive bladder cancer that is confined to the bladder wall and nearby lymph nodes, without spreading to other parts of the body. You must also be planning to have an operation to remove your bladder (a radical cystectomy). It's important that you haven't had chemotherapy or other immune-boosting cancer treatments for your bladder cancer before, and you should generally be in good health.

There are also some reasons why you might not be able to join. For example, if your cancer has spread widely, or if you've had certain types of radiotherapy to your pelvic area recently. The study also cannot include people who are taking medications that suppress the immune system, or who have certain active infections like Hepatitis or Tuberculosis.

The research team will carry out detailed checks to make sure the study is right and safe for you. They will explain everything clearly, and you'll have plenty of chances to ask questions.

Quick self-check
  • Do you have muscle-invasive bladder cancer?
  • Are you planning to have surgery to remove your bladder?
  • Have you *not* had prior chemotherapy or immunotherapy for your bladder cancer?
  • Do you generally feel well with good everyday activity levels?
  • Is your cancer currently only in the bladder or nearby lymph nodes, not spread widely?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will first undergo a series of assessments to confirm your eligibility. Once enrolled, you will receive treatment. This involves a period of receiving Durvalumab along with Gemcitabine and Cisplatin before your planned surgery. After your surgery to remove the bladder, you will then receive Durvalumab on its own for a period. Throughout the study, you will have regular hospital visits for various tests, scans, and to monitor your health and any side effects. The medical team will explain the exact schedule of visits and treatments, which will span several months, followed by a period of follow-up checks to see how you are doing long-term.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from a new treatment that could be more effective than current options, and you'll receive close medical attention. However, like all medications, Durvalumab and the chemotherapy drugs can cause side effects, which the study team will monitor closely. There's also no guarantee that the new treatment will be better for you. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (188)

  • Research Site
    Birmingham, United States
  • Research Site
    Los Angeles, United States
  • Research Site
    Palo Alto, United States
  • Research Site
    New Haven, United States
  • Research Site
    Chicago, United States
  • Research Site
    Geneva, United States
  • Research Site
    Iowa City, United States
  • Research Site
    Westwood, United States
  • Research Site
    Louisville, United States
  • Research Site
    New Orleans, United States
  • Research Site
    Towson, United States
  • Research Site
    Ann Arbor, United States

+176 more sites — see the official record for the full list.

Common questions

What is muscle-invasive bladder cancer?

This is a type of bladder cancer where the cancer cells have grown deeper into the muscle layer of the bladder wall.

What is Durvalumab?

Durvalumab is an immunotherapy drug that helps your body's immune system recognise and fight cancer cells.

Will I still need surgery if I join this study?

Yes, all patients in this study are planning to have an operation called a radical cystectomy, which removes the bladder.

What are Gemcitabine and Cisplatin?

These are common chemotherapy drugs often used to treat bladder cancer by killing cancer cells or slowing their growth.

How long will I be involved in the study?

The treatment phase will last several months, followed by a period of regular check-ups to monitor your progress and health over the long term.

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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