RecruitingPHASE2INTERVENTIONAL

Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations

This study is investigating new treatment options for muscle-invasive bladder cancer, which is a type of bladder cancer that has grown into the muscle wall. It's for patients whose cancer has a specific genetic change called an FGFR alteration and who cannot receive or have decided against standard chemotherapy before surgery. Researchers are testing a drug called erdafitinib alone, or erdafitinib combined with another drug called cetrelimab. These treatments are given for a short period before surgery to see if they can shrink the cancer effectively. The main aim is to find out if these drugs can reduce or completely remove the cancer detected in the bladder after surgery. This is a Phase 2 study, meaning it's still in the earlier stages of testing to see how well the treatments work and if they are safe.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Spanish Oncology Genito-Urinary Group

Enrolment target

Start

07 Mar 2023

Estimated completion

01 Oct 2029

Muscle-invasive Bladder Cancer

What is this study about?

This clinical trial is designed for people who have a specific type of bladder cancer called 'muscle-invasive bladder cancer' (MIBC). This means the cancer has grown into the muscular wall of the bladder. The study is particularly looking for patients whose cancer cells have a specific change in their genes, known as an 'FGFR alteration'. This genetic change can sometimes make cancer cells grow differently.

The main goal of this study is to explore new ways to treat this type of bladder cancer before surgery. Currently, some patients receive chemotherapy before surgery, but this study is for those who are unable to have that standard chemotherapy or have chosen not to. Researchers want to see if a drug called erdafitinib, either by itself or combined with another drug called cetrelimab, can shrink the cancer or even make it disappear before an operation to remove the bladder.

By testing these treatments before surgery, doctors hope to understand how well they work to reduce the size of the tumour. The key measure of success will be looking at tissue from the bladder after surgery to see if the cancer has shrunk significantly or is completely gone. This research is important because it could lead to new and effective treatment options for people with this specific type of bladder cancer.

Key takeaways

This study evaluates new pre-surgery treatments for muscle-invasive bladder cancer.
It's for patients whose cancer has a specific genetic change (FGFR alteration).
It's an option for those who cannot receive standard pre-surgery chemotherapy.
Treatments include erdafitinib alone or with cetrelimab, given before bladder removal surgery.
The main goal is to see if the drugs can shrink or eliminate the cancer before surgery.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be 18 years or older and have been diagnosed with muscle-invasive bladder cancer that has reached the muscle wall, but hasn't spread widely to other parts of your body (N0/N1 M0). Your doctors will also need to confirm that your cancer cells have a specific genetic change called an 'FGFR alteration' from a biopsy.

It's also important that you are not able to receive, or have chosen not to have, standard chemotherapy treatment with cisplatin before surgery. You should be generally well and able to manage daily activities, as measured by a health score called ECOG 0-1. You must not have had certain other cancer treatments in the past, such as specific targeted therapies, immunotherapy, or radiation for bladder cancer.

People who cannot join this study include those whose cancer has spread more widely, or who have certain other types of cancer. You also wouldn't be able to participate if you are not considered fit enough for bladder removal surgery or if you decline the surgery itself. Women must not be pregnant or breastfeeding, and both men and women must agree to use effective birth control during the study.

Quick self-check

Are you 18 years old or older?
Do you have muscle-invasive bladder cancer (T2-4a N0/N1 M0)?
Has your doctor confirmed your cancer has an 'FGFR alteration'?
Are you unable to, or have you chosen not to have, standard cisplatin chemotherapy before surgery?
Are you generally well and active (ECOG 0-1 score)?
Have you not had certain previous treatments like specific targeted therapies or immunotherapy for bladder cancer?

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'll first go through a screening process to make sure you're suitable. Once confirmed and you've agreed to take part, you'll be assigned to one of two groups: one receiving erdafitinib on its own, and the other receiving erdafitinib plus cetrelimab. Erdafitinib is usually taken as a pill, while cetrelimab is given into a vein (intravenously).

This treatment will be given for a period before you have an operation called a Radical Cystectomy, which is surgery to remove your bladder. This surgery will typically happen within 2 to 6 weeks after your last dose of the study medication. You'll have scans like CT, MRI, or PET scans before starting treatment and again before your surgery to check how the cancer is responding. After surgery, the removed tissue will be carefully examined. You'll then have follow-up visits and scans to monitor your health and ensure the cancer hasn't returned, following standard hospital practices. If your cancer gets worse during treatment, you would stop taking the study drugs.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to new treatments that could shrink your bladder cancer before surgery, potentially leading to better outcomes than if you didn't have these treatments. However, like all medications, the study drugs (erdafitinib and cetrelimab) can have side effects, which your doctor will explain in detail. There's also no guarantee that the treatment will work for you. It's very important to remember that joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (23)

CLCC Jean Perrin
Clermont-Ferrand, France· Recruiting
CLCC Léon Bérard
Lyon, France· Withdrawn
Institut Mutualiste Montsouris
Paris, France· Recruiting
IUCT
Toulouse, France· Recruiting
Institut Gustave Roussy
Villejuif, France· Recruiting
IRCCS San Raffaele Hospital and Scientific Institute
Milan, Italy· Recruiting
A.O. Ordine Mauriziano, Ospedale Umberto I
Turi, Italy· Withdrawn
Ospedale Molinette
Turin, Italy· Recruiting
Hospital Clínic De Barcelona
Barcelona, Spain· Recruiting
Hospital De Sabadell (Parc Taulí)
Barcelona, Spain· Recruiting
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain· Recruiting
Hospital Universitario Lucus Augusti
Lugo, Spain· Recruiting

+11 more sites — see the official record for the full list.

Common questions

What is 'muscle-invasive bladder cancer'?

This means the bladder cancer has grown deeply into the muscular wall of the bladder.

What is an 'FGFR alteration'?

It's a specific change in the genes of the cancer cells that can affect how they grow. This study is for people whose cancer has this particular change.

What does 'neoadjuvant treatment' mean?

It means the treatment (like the study drugs) is given for a short time before the main surgery to remove the bladder, with the aim of shrinking the cancer first.

Are erdafitinib and cetrelimab available outside of this study?

As these are investigational treatments for this specific situation, they are being tested within this clinical trial and aren't typically available as a standard treatment for this condition yet.

What is a 'Phase 2' study?

This means it's an earlier stage of testing where researchers are looking to see how well a new treatment works and if it's safe for a larger group of people, after initial safety tests in Phase 1.

How to find out more

Isabel Grau

trialmanager@sogug.es 0034610286915 Official trial record

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