Active not recruitingPHASE1INTERVENTIONAL

Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

This study is looking for new ways to treat muscle-invasive bladder cancer that has spread and hasn't improved with standard treatments. It's an early-stage study testing several new medicines, both on their own and in different combinations. The researchers want to find out if these new drugs are safe, how well the body handles them, and if they can shrink the cancer. To help decide which treatment group you might fit into, doctors will check your tumour for specific genetic changes, like looking at its unique 'fingerprint'. This helps them match you with the treatment that's most likely to be effective for your specific type of cancer. The study is split into several smaller parts, each focusing on a different drug or drug combination.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

117

Start

28 Dec 2016

Estimated completion

30 Jan 2026

Muscle Invasive Bladder Cancer

What is this study about?

This study is designed for individuals in the UK who have a type of bladder cancer called muscle-invasive bladder cancer, which has spread to other parts of the body and hasn't responded well to previous treatments. The main goal is to explore several new medications that haven't been widely used yet, to see how safe they are and if they can help fight the cancer. Think of it like trying out new tools in a toolkit to see which ones work best for a specific problem.

The study is set up in a clever way, almost like having smaller 'mini-studies' within a larger one. Each mini-study focuses on a different new drug or a combination of two drugs. To make sure patients receive the most suitable treatment, doctors will first check your tumour for certain genetic changes. These changes act like a special marker, helping the doctors match you to the specific drug or drug combination that is designed to target those changes in your cancer. This personalised approach aims to make the treatment more effective.

By carefully testing these new treatments, the researchers hope to find out the best and safest doses, how the drugs behave in the body, and importantly, if they can slow down or shrink the cancer. This information is key for developing better treatments for bladder cancer in the future. The study is in an early phase, meaning it's still investigating the basics, but it's a vital step towards finding more effective options.

Key takeaways

It's for bladder cancer that's spread and hasn't responded to previous treatment.
Tests new drugs, alone or in combinations, for safety and effectiveness.
Your tumour's unique genetic code helps match you to the best possible experimental treatment.
You'll have regular hospital visits for blood tests and scans.
You might get access to new treatments before they are widely available.

Who may be eligible?

To join this study, you generally need to have muscle-invasive bladder cancer that has spread and has not responded to previous treatments. You must also be well enough to take part, meaning you can mostly look after yourself and move around without much difficulty.

Depending on which specific treatment group you might be offered, your cancer cells will be tested for certain genetic changes. For example, some groups might need specific changes in a gene called FGFR, while others might look for changes in genes related to how cells repair themselves. These specific 'markers' help doctors decide which treatment might be best for you.

There are also some reasons why you might not be able to join. For instance, if you've had recent surgery, radiotherapy, or another cancer treatment, or if you have certain heart problems, autoimmune diseases, or other serious health conditions. You'll need to discuss all your medical history with the study team.

Quick self-check

Do I have bladder cancer that has spread?
Has my bladder cancer not responded to previous treatments?
Am I generally well, able to look after myself and move around?
Have I discussed with my doctor if my tumour has specific genetic changes?
Have I avoided recent major surgery, chemotherapy, or radiotherapy?
Do I have good organ function (kidneys, liver, etc.) as confirmed by blood tests?

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

What does participation involve?

If you join this study, you will be given a specific new drug or a combination of two new drugs. These might be given as tablets you swallow or through a drip into your vein.

You'll have regular visits to the hospital for checks. These visits will involve blood tests, physical exams, and scans (like CT scans) to see how you're responding to the treatment and to keep an eye on any side effects. The study will continue for as long as the treatment is helping you and you're not experiencing severe side effects. Once you stop treatment, you'll still have follow-up appointments to monitor your health. The exact length of the study will vary depending on your response, but generally, you'll be on treatment for a period determined by its effectiveness.

Potential risks and benefits

Taking part in this study may offer some potential benefits, as you'll have access to new treatments that are not yet widely available. There's a chance these treatments might help control your cancer, even if previous treatments haven't worked. However, like all medicines, these drugs can cause side effects, which could range from mild to serious. The research team will carefully monitor you for any side effects and manage them as best they can. It's important to remember that new treatments don't work for everyone, and your condition may not improve. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (27)

Research Site
Los Angeles, United States
Research Site
New Haven, United States
Research Site
Fort Myers, United States
Research Site
New York, United States
Research Site
New York, United States
Research Site
New York, United States
Research Site
Cleveland, United States
Research Site
Nashville, United States
Research Site
Edmonton, Canada
Research Site
Vancouver, Canada
Research Site
Toronto, Canada
Research Site
Montreal, Canada

+15 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 into the deeper layers of the bladder wall or beyond.

What does 'early-stage study' mean?

It means this is one of the first times these new drugs are being tested in people. The main goals are to check their safety and how well the body tolerates them, as well as looking for signs they could work against the cancer.

Why will my tumour be tested for genetic changes?

Testing your tumour helps doctors understand its unique 'fingerprint'. This guides them in choosing which experimental treatment might be most effective for your specific cancer type, making the approach more personalised.

Will I get a placebo (dummy drug) in this study?

No, this is an 'open-label' study, meaning everyone in the study will receive one of the active new treatments or a combination of them. There's no placebo arm.

Can I continue my regular medications during the study?

Some medications might interfere with the study drugs. You will need to tell the study team about all medications you are taking, including over-the-counter drugs and supplements, so they can advise you.