Active not recruitingPHASE3INTERVENTIONAL

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

This important study is for adults with a type of bladder cancer called muscle-invasive bladder cancer, which means the cancer has grown into the muscle layer of the bladder. The main point of the study is to compare two ways of treating this cancer. One way is the standard chemotherapy treatment (gemcitabine and cisplatin). The other way is the same standard chemotherapy, but with an additional immunotherapy drug called nivolumab. In the study, some people will receive nivolumab along with chemotherapy before their surgery, and then continue with nivolumab after surgery. The researchers want to find out if adding nivolumab to chemotherapy is more effective than chemotherapy alone in treating this condition and improving outcomes for patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

855

Start

06 Nov 2018

Estimated completion

30 Dec 2027

Urinary Bladder Neoplasms Muscle-Invasive Bladder Cancer

What is this study about?

This study is about helping people with a serious type of bladder cancer where the cancer has grown into the muscle of the bladder wall. This is called muscle-invasive bladder cancer. Usually, treatment involves chemotherapy followed by surgery to remove part or all of the bladder.

Researchers are always looking for better ways to treat cancer. In this study, they are investigating if adding a newer type of drug, called immunotherapy (specifically nivolumab and another drug called BMS-986205), to standard chemotherapy can improve how well people do. Immunotherapy works by helping your body's own immune system fight the cancer cells. This study will also look at whether continuing the immunotherapy after surgery helps prevent the cancer from coming back.

By comparing these different treatment approaches, the study aims to find out if the combination of chemotherapy and immunotherapy, followed by further immunotherapy after surgery, is more effective than just chemotherapy before surgery. The hope is that this research will lead to better treatments and outcomes for patients with muscle-invasive bladder cancer in the future.

Key takeaways

New study for adults with muscle-invasive bladder cancer.
Compares standard chemotherapy with chemotherapy plus immunotherapy (nivolumab).
Treatment is given before and after surgery.
Aims to find out if adding immunotherapy improves treatment effectiveness.
Participation involves regular check-ups and monitoring.
You can stop participating at any time.

Who may be eligible?

This study is open to adults aged 18 and over who have muscle-invasive bladder cancer that hasn't spread to distant parts of the body. You must also be well enough to have surgery to remove your bladder (called a radial cystectomy) and agree to have this surgery after the initial treatment phase of the study.

To be considered, your overall health should be good enough to take part in a study like this. Doctors use a simple score to check how well you're managing your daily activities; you'd need a score of 0 or 1, meaning you're fully active or can do most things with some effort.

However, you can't join if scans show your lymph nodes (small glands that are part of your immune system) are very enlarged (10mm or more) or if the cancer has already spread to other parts of your body. Also, if you've already had chemotherapy, radiotherapy, or major surgery for your bladder cancer (other than a procedure to remove bladder tumours through the urethra), you won't be able to participate.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with muscle-invasive bladder cancer?
Are you healthy enough for bladder removal surgery and willing to have it?
Has your bladder cancer not spread to major lymph nodes or distant parts of your body?
Have you not had chemotherapy or radiation for your bladder cancer before (other than a minor procedure)?
Are you generally able to carry out your daily activities without much difficulty?

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'll be randomly assigned to one of several treatment groups. This means you might receive standard chemotherapy alone, or chemotherapy combined with nivolumab or nivolumab plus BMS-986205. These treatments are given before your bladder surgery. After your surgery, if you were in an immunotherapy group, you would continue with nivolumab or nivolumab plus BMS-986205 for a period of time. You will have regular appointments for check-ups, blood tests, and scans throughout the treatment period and for some time afterwards to monitor your health and the effectiveness of the treatment. The exact number of visits, tests, and total duration will be explained in detail by the study team, but generally, studies like this involve several months of active treatment and follow-up spanning a few years.

Potential risks and benefits

Participating in this study might offer you the potential benefit of receiving a new, potentially more effective treatment for your bladder cancer, which could improve your outcome. However, new treatments can also have side effects that aren't fully known, and all treatments carry risks. You might experience side effects from the chemotherapy or the immunotherapy drugs, which the study team will monitor closely. You are completely free to withdraw from the study at any time, for any reason, without it affecting the standard medical care you receive.

Locations (172)

Local Institution - 0022
Tucson, United States
UC Davis Comprehensive Cancer Center
Sacramento, United States
Local Institution - 0021
Littleton, United States
Local Institution - 0036
Pensacola, United States
Local Institution - 0004
Tampa, United States
Local Institution - 0144
Atlanta, United States
Local Institution - 0005
Chicago, United States
Local Institution - 0006
Peoria, United States
Local Institution - 0181
Columbia, United States
Local Institution - 0009
Boston, United States
Local Institution - 0166
Boston, United States
Local Institution - 0209
Boston, United States

+160 more sites — see the official record for the full list.

Common questions

What is muscle-invasive bladder cancer?

It's a type of bladder cancer where the cancer has grown into the muscular wall of the bladder.

What is nivolumab?

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

What does 'neoadjuvant therapy' mean?

It means the treatment (like chemotherapy or immunotherapy) is given before the main surgery.

Will I definitely get the new immunotherapy drug?

You will be randomly assigned to a treatment group, so you might receive the standard treatment or the treatment with the immunotherapy drug. It's like drawing lots.

How long will I be in the study?

The study involves active treatment for several months, followed by regular check-ups that could last for a few years, but the exact timeframe will be discussed with you.