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About Bladder Cancer Research

Current bladder cancer treatment options vary depending on whether your cancer is muscle-invasive or non-muscle invasive. The VISTA study is for people with non-muscle invasive bladder cancer, which occurs when the cancer is limited to the lining of the bladder and has not spread into the bladder muscle or the rest of the body.

For patients who have been diagnosed with non-muscle invasive bladder cancer, treatment options include immunotherapy, intravesical chemotherapy, transurethral resection (TURBT), and possibly bladder removal surgery (cystectomy). A type of immunotherapy called Bacillus Calmette-Guérin (BCG) is often a first choice for treatment.

However, if your bladder cancer returned or continued to grow despite treatment with BCG, then cystectomy may be one of the options considered to prevent the cancer from progressing and spreading to other organs.

Despite the high number of people with non-muscle invasive cancer, the development of bladder cancer treatment options for non-muscle invasive bladder cancer has been minimal within the last 25 years.

The VISTA clinical research study is a bladder cancer clinical research study that is evaluating whether an investigational drug may help people with non-muscle invasive bladder cancer that has returned or progressed after initial treatment with BCG.

About the Study

The VISTA bladder cancer clinical research study is evaluating whether Viventia Bio’s investigational drug, Vicinium, is safe and effective for patients with bladder cancer that has not yet spread to the bladder muscle and who have previously received BCG treatment. More than 100 patients with this type of bladder cancer have been treated with Vicinium in a prior Phase I and Phase II study.

Vicinium is considered investigational because it is not approved by health authorities, including the U.S. Food and Drug Administration (FDA), for the treatment of bladder cancer.

What is the study drug?

Vicinium aims to treat bladder cancer using targeted therapy. Targeted therapy is different from traditional chemotherapy in that targeted therapy drugs aim to more precisely identify and destroy only cancer cells without causing unnecessary harm to healthy cells.

Vicinium actively targets bladder cancer cells while avoiding healthy bladder cells by finding specific proteins that typically appear on those bladder cancer cells, then attacking the cells that contain those proteins. Once inside the cancer cell, Vicinium shuts down the processes the cancer cell needs to survive, leading to the death of the cancer cell.

Vicinium is a liquid that is put into the bladder with a catheter. Previous clinical studies have shown Vicinium to be well-tolerated, meaning it showed minimal side effects. The most commonly reported reactions were urinary pain and blood in the urine.

Who can participate?

You may be able to join the study if you:

  • Are at least 18 years of age
  • Have non-muscle invasive bladder cancer that progressed or returned

There are other criteria you must meet to participate in the VISTA study. A study doctor and study staff can explain these criteria to you in greater detail.

What will happen during the study?

The study has two parts and will last for about 2 years.

If you are eligible and agree to participate, during the first part of the study, you will receive Vicinium at the study site for about 3 months. You will receive it twice a week for 6 weeks and then once a week for 6 weeks.

After 3 months of treatment, if there is no evidence of your bladder cancer and if you are not having severe side effects from taking Vicinium, you will have the opportunity to begin the second part of the study. During the second part of the study, you will visit the study site every other week for up to 2 years to receive Vicinium, as long as the cancer does not return.

Study visits during both parts of the study will last about 3 hours each. At these visits, you will have study-related tests and procedures and your health will be monitored.

Throughout the study, you will have examinations of your bladder. If tumors are found, biopsies will be done.

Study participation is completely voluntary and you can stop participating at any time. While Vicinium may or may not effectively treat your cancer, what we learn from this study may help doctors find a new treatment option for patients with non-muscle invasive bladder cancer.

About Clinical Research

Clinical research studies (also called clinical trials) are scientific studies done to test investigational drugs for diseases and conditions. Studies help determine if investigational drugs are safe to use and work to improve the health of people. Before any drug can be approved and made available to the general public, it has to go through several phases of clinical research.

Why do people participate in studies?

People participate in clinical research studies for a variety of reasons. Some volunteers may participate in studies because they want to learn more about their disease. Others volunteer to participate because they want to help researchers learn more about a disease so that it may help them and others in the future.

Are clinical studies safe?

Clinical research studies follow a specific set of standards and are closely regulated to help ensure the safety of all participants. Safety precautions are put in place to protect people who participate in clinical research. In addition, studies follow a written plan that is called a protocol. The protocol is reviewed by an Institutional Review Board, which is a group of people that is responsible for safeguarding the safety and rights of research subjects. Before you participate in any clinical research study, you will review potential risks and benefits, and the study staff will answer any questions you may have.

What if I have questions during the study?

You can ask questions of the study team at any point before, during, and after the study. Before agreeing to participate, please make sure that you understand the responsibilities of study participants. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study team at any time.

Can I leave the study once it has started?

Study participation is completely voluntary. You do not need to take part in the study, and you can end your participation at any time, for any reason. If you think you would like to stop participating in the study, talk to the study doctor. If you decide you should leave the study early, the study doctor may ask that you return to the study site for a final visit, but there will be no negative impact on the care you receive.

Is there a cost to participate?

All study-related drugs, procedures, and tests will be provided at no cost to you.