RecruitingPHASE3INTERVENTIONAL

Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)

The NIAGARA-2 study is investigating a new treatment approach for bladder cancer that has spread into the muscle wall (called muscle-invasive bladder cancer). This type of cancer often requires surgery. Researchers want to see if adding a modern cancer drug called durvalumab, both before and after surgery, to standard chemotherapy (either ddMVAC or gemcitabine/cisplatin) is an effective and safe treatment. This study builds on earlier research and aims to understand how this combination works in a real-world setting. Participants would receive a combination of medicines to try and shrink the cancer before surgery, and then durvalumab afterwards, with the goal of improving long-term outcomes.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

150

Start

15 May 2025

Estimated completion

31 Oct 2028

Urinary Bladder Neoplasms Immune Checkpoint Inhibitors Methotrexate Vinblastine Doxorubicin Cisplatin Gemcitabine

What is this study about?

This study, called NIAGARA-2, is looking into treating a type of bladder cancer that has spread into the muscle layer of the bladder. This is a serious condition where surgery to remove the bladder (called a radical cystectomy) is often needed. Before surgery, patients usually receive chemotherapy to try and shrink the tumour first. This study is testing if adding a newer type of cancer drug, called durvalumab, to this chemotherapy and continuing it after surgery, can make the treatment even better.

Durvalumab is a type of immunotherapy. This means it works by helping your body's own immune system fight the cancer. The study is focused on finding out if combining durvalumab with two different standard chemotherapy treatments (either ddMVAC or gemcitabine/cisplatin) is effective and safe. They are especially interested in how this new approach works in a typical hospital setting, reflecting how patients are treated every day.

By carefully studying this treatment combination, researchers hope to improve how muscle-invasive bladder cancer is treated in the future. The overall goal is to find ways to give people with this type of bladder cancer a better chance of recovering and staying well.

Key takeaways

This study is for muscle-invasive bladder cancer.
It combines a new immune therapy (durvalumab) with standard chemotherapy.
Treatment is given before and after bladder removal surgery.
Aims to improve outcomes for this type of cancer.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

To join this study, you would generally need to have bladder cancer that has grown into the muscle but has not spread widely to distant parts of your body. Your doctors must also be planning for you to have surgery to remove your bladder. You should not have received any chemotherapy or immunotherapy for your bladder cancer before now. Your general health should also be good enough to take part in the study, meaning you can mainly look after yourself and are expected to live beyond three months.

There are also reasons why you might not be able to join. For example, if your cancer has spread to many lymph nodes or to distant organs in your body. Also, if your tumour is very large and essentially 'stuck' to your pelvic wall, making surgery very difficult. If you've previously had certain types of immune-boosting cancer treatments (apart from BCG for bladder cancer), or if you're taking medicines that suppress your immune system, you might not be eligible. They will also check if you have any other serious health issues that are not properly controlled, or if any of the study medications conflict with other medicines you are taking.

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.

Do you have bladder cancer that has grown into the muscle?
Are your doctors planning surgery to remove your bladder?
Have you not had chemotherapy or immunotherapy for this cancer before?
Do you feel well enough to mostly look after yourself?
Has your cancer not spread widely to distant parts of your body?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive a combination of medications. This would involve chemotherapy, which you would have before your bladder surgery, along with doses of durvalumab. After your surgery, you would continue to receive durvalumab alone for a period. You would have regular hospital visits for these treatments and for check-ups, where doctors would ask about your health, do physical examinations, and take blood samples. These visits are important to monitor how you are responding to the treatment and to keep an eye on any side effects. The exact number of visits and the full length of your participation would be explained by the study team, but it will involve treatment before surgery, the surgery itself, and then ongoing treatment and follow-up afterwards.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is that the combination of durvalumab and chemotherapy might offer a more effective way to treat your bladder cancer compared to standard care, potentially improving your chances of a better outcome. However, there are also potential risks, including side effects from the chemotherapy and durvalumab, which can vary from person to person. All possible side effects will be fully explained to you. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (59)

Research Site
Verified postcode
Chermside, Australia· Recruiting
Research Site
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Elizabeth Vale, Australia· Recruiting
Research Site
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Heidelberg, Australia· Recruiting
Research Site
City only
Hong Kong, Australia· Recruiting
Research Site
Verified postcode
Kogarah, Australia· Recruiting
Research Site
City only
Macquarie University, Australia· Recruiting
Research Site
Verified postcode
Murdoch, Australia· Recruiting
Research Site
Verified postcode
Port Macquarie, Australia· Recruiting
Research Site
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St Leonards, Australia· Recruiting
Research Site
Verified postcode
Barretos, Brazil· Recruiting
Research Site
Verified postcode
Jaú, Brazil· Withdrawn
Research Site
Verified postcode
Natal, Brazil· Withdrawn

Common questions

What is durvalumab?

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

What is 'muscle-invasive bladder cancer'?

This means that the bladder cancer has grown into the muscle layer of the bladder wall, which is a more advanced stage of the disease.

Will I still need surgery if I join this study?

Yes, this study is for individuals who are still planning to have surgery to remove their bladder (radical cystectomy).

What kind of chemotherapy is involved?

The study uses two common chemotherapy combinations: ddMVAC or gemcitabine/cisplatin. Your doctor will decide which is most suitable for you.

How long will I be in the study?

You will receive treatment before surgery, have surgery, and then continue with further treatment and follow-up. The exact duration will be discussed with the study team.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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