AuthorisedTherapeutic exploratory (Phase II)Interventional

An Open-label, Single-arm, Global Study of Perioperative Durvalumab With Cisplatin-based Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)

This study, called NIAGARA-2, is testing a new approach for people with muscle-invasive bladder cancer. Participants will receive a drug called Durvalumab (also known as IMFINZI) along with standard chemotherapy before they have surgery to remove the bladder. The main aim is to carefully monitor for any serious side effects that might happen before the surgery. Researchers will also be looking at how well this treatment helps prevent the cancer from coming back, how long people live, and how much of the cancer is removed or reduced by the treatment before surgery. This is a Phase II study, meaning it’s an early stage to explore how safe and effective the treatment might be.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

AstraZeneca AB

Enrolment target

Start

19 May 2026

Patients With Muscle-Invasive Bladder Cancer

What is this study about?

This study, known as NIAGARA-2, is looking into a new way to treat muscle-invasive bladder cancer. This type of bladder cancer has grown into the muscle wall of the bladder and often requires surgery to remove the bladder.

In this study, doctors are combining a new drug called Durvalumab (which you might hear referred to by its brand name, IMFINZI) with standard chemotherapy. Both of these treatments will be given before surgery. Durvalumab is a type of immunotherapy, which helps your body's own immune system fight cancer cells. The idea is that giving these treatments before surgery might help shrink the cancer or make the surgery more effective.

The main goal is to carefully check for any serious side effects that might happen during the period leading up to surgery. Researchers will also be tracking how long people live, if the cancer comes back after treatment, and how much the tumour has shrunk or completely disappeared by the time surgery happens. This information will help doctors understand if this new treatment combination is safe and could be a good option for future patients.

Key takeaways

This study combines a new drug (Durvalumab) with standard chemotherapy for bladder cancer.
Treatment is given before bladder removal surgery.
The main focus is to check for serious side effects.
It's also exploring how well the treatment works against the cancer.
This is an early stage (Phase II) study to gather important information.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults are also welcome to participate if they meet other health criteria.

This study includes both men and women. The specific type of cancer being studied is muscle-invasive bladder cancer.

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.

I am at least 18 years old.
I have been diagnosed with muscle-invasive bladder cancer.
I am male or female.

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive doses of Durvalumab (IMFINZI) alongside chemotherapy before your planned bladder removal surgery. You will have regular appointments for check-ups, blood tests, and scans to monitor your health and how your body is responding to the treatment. Doctors will be looking out for any side effects and how well the treatment is working against the cancer. After the surgery, you will continue to have follow-up appointments to track your recovery and long-term health. The total duration of your participation, including follow-up, will be discussed with you by the study team.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from a new treatment that isn’t yet widely available, and you'll receive close medical attention. However, there's always a risk of side effects from the medications, some of which could be serious. All potential risks will be thoroughly explained to you before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Spain
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Unverified
France
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Unverified
Netherlands

Common questions

What is Durvalumab (IMFINZI)?

Durvalumab is a type of medicine called immunotherapy. It works by helping your body's immune system recognise and fight cancer cells.

What does 'muscle-invasive bladder cancer' mean?

This means the bladder cancer has grown into the muscle layer of the bladder wall. It's a more advanced type of bladder cancer.

Why are they giving treatment before surgery?

Giving treatment before surgery (called 'neoadjuvant' treatment) aims to shrink the tumour or kill cancer cells, potentially making the surgery more effective or easier.

What does 'Phase II' mean for a study?

Phase II studies are an early stage of research. They focus on finding out if a new treatment is safe and if it shows promise in treating the disease, usually in a larger group of patients than earlier studies.

Will my regular doctors still be involved?

Yes, your regular doctors will still be involved in your care and will work with the study team to ensure you receive the best overall treatment.