Active not recruitingPHASE2INTERVENTIONAL

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

This research study, called JAVELIN Bladder Medley, is exploring new treatment options for people with bladder cancer that has spread to other parts of the body or is locally advanced. The main goal is to find out how safe and effective a cancer drug called avelumab is when given on its own or alongside other anti-cancer medications. Researchers want to see if these combinations can help manage the cancer more effectively and potentially improve patients' health. This study involves several different drugs and combinations, and doctors will carefully monitor participants to understand the benefits and any side effects. It’s for patients who have already had initial chemotherapy for their bladder cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

EMD Serono Research & Development Institute, Inc.

Enrolment target

256

Start

17 Aug 2022

Estimated completion

25 Jun 2026

Locally Advanced or Metastatic Urothelial Carcinoma

What is this study about?

This study, known as JAVELIN Bladder Medley, is designed to investigate new treatment approaches for bladder cancer that has either spread to other parts of the body (metastatic) or is advanced in a local area (locally advanced) and cannot be removed by surgery. Bladder cancer is a serious condition, and researchers are always looking for better ways to treat it, especially when it has progressed.

The main drug being studied is avelumab, which is an immunotherapy. Immunotherapy works by helping your body's own immune system fight cancer cells. In this study, avelumab is being tested in various combinations with other anti-cancer drugs, such as Sacituzumab Govitecan, M6223, and NKTR-255. The aim is to see if combining these treatments can lead to better results than using a single drug.

The study will carefully assess both the safety of these drug combinations and how well they work (their effectiveness). This means doctors will be looking for any side effects participants may experience, as well as whether the treatments help to control the cancer. The findings from this research could help offer more options for future bladder cancer treatments.

Key takeaways

This study investigates new combinations of drugs, including avelumab, for advanced bladder cancer.
It aims to find out how safe and effective these new treatments are.
It's for people whose bladder cancer has spread or is locally advanced and have already had initial chemotherapy.
Participation involves regular hospital visits, checks, and scans.
You can stop participating at any time.
The study explores potential new treatment options for bladder cancer patients.

Who may be eligible?

To join this study, you would typically need to have bladder cancer that has been confirmed by a doctor and is either locally advanced (meaning it has grown significantly but can't be surgically removed) or has spread to other parts of your body. Your cancer would need to be mainly the type called 'transitional cell carcinoma'. You must have already completed 4 to 6 cycles of initial chemotherapy for your bladder cancer, and your cancer should not have gotten worse after this treatment. The last dose of your chemotherapy must have been given between 4 and 10 weeks before potentially starting this study. You should also generally be in good health, able to carry out most daily activities, and expected to live for at least another three months.

There are also reasons why you might not be able to join. For example, if you have previously received certain types of immunotherapy or other specific anti-cancer drugs, including ones similar to those used in this study, you would likely not be eligible. Active infections needing treatment within 48 hours of starting the study, or a known severe allergy to any of the study drugs, would also prevent your participation. The study team will review all your medical information carefully to see if this study is right for you.

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 have bladder cancer that is locally advanced or has spread.
My cancer is mainly the type called 'transitional cell carcinoma'.
I have already completed 4 to 6 cycles of initial chemotherapy, and my cancer has not worsened since then.
My last chemotherapy dose was between 4 and 10 weeks ago.
I haven't had certain types of previous immunotherapy or specific anti-cancer drugs.
I generally feel well and can do most of my daily activities.

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive treatment with avelumab, possibly combined with one of the other study drugs. You will have regular appointments at the hospital, which will involve physical examinations, blood tests, and scans (like CT or MRI). These tests are important to check how well the treatment is working and to monitor for any side effects. The exact number of visits and tests will depend on which treatment group you are in and will be explained in detail by the study team. You'll continue to be monitored for some time after your treatment finishes. The total duration of your participation, including follow-up, will be clearly outlined by the study team.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as receiving new treatments for your bladder cancer that are not yet widely available. These treatments might help control your cancer. However, like all medications, the study drugs may cause side effects, some of which could be serious. The study team will closely monitor you for any side effects and manage them as best as possible. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (97)

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

Beacon Cancer Care
Verified postcode
Coeur d'Alene, United States
University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)
Verified postcode
Kansas City, United States
Johns Hopkins University
Verified postcode
Baltimore, United States
The Johns Hopkins Hospital
Verified postcode
Baltimore, United States
AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center
Verified postcode
Kansas City, United States
Seattle Cancer Care Alliance
Verified postcode
Seattle, United States
Multicare Health System Tacoma General Hospital
Verified postcode
Tacoma, United States
University of Wisconsin Cancer Center
Verified postcode
Madison, United States
Flinders Medical Centre
Verified postcode
Bedford Park, Australia
Sunshine Hospital - PARENT
Verified postcode
Footscray, Australia
Ashford Cancer Centre Research
Verified postcode
Kurralta Park, Australia
Liverpool Hospital - PARENT
Verified postcode
Liverpool, Australia

Common questions

What is 'locally advanced or metastatic' bladder cancer?

Locally advanced means the cancer has grown quite a bit within the bladder area or nearby, but can't be removed by surgery. Metastatic means the cancer has spread to other parts of the body.

What is avelumab?

Avelumab is a type of immunotherapy. It works by helping your body's own immune system find and fight cancer cells.

Do I have to pay to be part of the study?

No, all study-related treatments and tests will be provided free of charge.

What if the treatment doesn't work for me?

Your doctors will regularly monitor your cancer. If the treatment isn't working or if you have severe side effects, they would discuss other treatment options with you.

Will I know which drugs I'm receiving?

Yes, in this type of study, you will know which specific treatment combination you are receiving.