How to Find and Evaluate Clinical Trials for Metastatic Bladder Cancer

Enrolling in a clinical trial offers a unique opportunity to participate in cancer research. “Today’s standard treatments were once clinical trials,” says Fernando Maciel Barbosa, MD, a medical oncologist with the University of Iowa Health Care in Iowa City. “Participation helps advance care while potentially providing access to promising therapies.”

A clinical trial can be a good option when you have bladder cancer that has metastasized, or spread to other parts of your body.

“One of the most important conversations I have with patients with bladder cancer is whether a clinical trial should be part of their treatment plan,” says Charles B. Nguyen, MD, a medical oncologist at City of Hope Lennar Foundation Cancer Center in Irvine, California, who specializes in bladder and other genitourinary cancers. “I encourage patients to ask about clinical trials early because, for some patients, the best opportunity to participate is before a particular treatment has begun.”

If you’re interested in entering a clinical trial, you may be unsure where to begin. But finding and evaluating them is not as overwhelming as it may seem, and it doesn’t require a medical degree.

Clinical Trial Phases: What Do They Mean?

“They move through a series of phases, with each phase answering different questions before a treatment becomes widely available,” says Dr. Nguyen. “Each phase builds on the one before it, helping ensure that new therapies are evaluated as carefully and safely as possible.”

• Phase 1 The first step focuses on safety. In drug studies, the goal of phase 1 trials is to find the highest dose of a new treatment that can be safely given without causing severe side effects. The first participants get a very low dose. If it’s tolerated, the next group gets a higher dose and so on until a dose is reached that has an acceptable level of side effects and is likely to have a benefit. Phase 1 trials typically include about 20 to 80 people.
• Phase 2 After a drug is determined to be safe, researchers move forward with a phase 2 trial, which may include up to several hundred people. A phase 2 trial studies whether this treatment is effective against this cancer type. “More patients receive the therapy to evaluate antitumor activity while continuing to monitor safety,” says Dr. Barbosa.
• Phase 3 This phase compares the new treatment against the current standard of care. These studies are usually much larger and may gather data for several years. If the clinical trial is successful, the manufacturer uses the results to seek approval from the U.S. Food and Drug Administration (FDA).
• Phase 4 After the new product has been approved and enters the market, the FDA will continue to collect data over a longer period of time. Phase 4, or postmarketing trials, may involve thousands of people and monitor safety and other aspects of the treatment, including cost effectiveness and how it impacts quality of life.

“It’s important to note that some trials are randomized, meaning you either get assigned the study treatment or a different treatment, but other trials are not randomized, in which patients just get the study drug,” says Nguyen.

He adds that in cancer research, you generally do not have to worry about getting a placebo (a treatment that doesn’t contain active medicine). You’ll at least receive whatever is the standard treatment for your situation.

Step-by-Step: How to Find Trials That Fit Your Medical History

If you’re interested in participating in a clinical trial, start by discussing it with your doctor. “The first conversation should almost always be with the patient’s medical oncologist,” says Barbosa. They understand your specific situation and can tell you if a clinical trial might be appropriate.

“Many academic cancer centers have dedicated clinical trial coordinators or research nurses who help identify suitable studies,” he says.

Step 1: Gather Your Medical Details

To evaluate whether a particular study might be right for you, Barbosa says that you’ll need several pieces of information:

• The exact diagnosis (such as urothelial carcinoma or another bladder cancer subtype)
• Whether and where the cancer has spread
• Your previous treatments and how well they worked
• Performance status, or how active you are in daily life
• Kidney function
• Other medical conditions
• Molecular testing results, when available

“For bladder cancer, biomarkers have become increasingly important, especially in clinical trials,” Barbosa says. Cutting-edge treatments often target specific vulnerabilities in the cancer cells, like gene mutations. These include alterations in the FGFR2 or FGFR3 genes and overexpression of the growth-promoting protein HER2.

The National Cancer Institute has a checklist that can help you gather the information you need to find a suitable clinical trial.

Step 2: Check the Trial Registries

There are several databases that you can use to search for a clinical trial:

• ClinicalTrials.gov
• CenterWatch
• National Cancer Institute
• Bladder Cancer Advocacy Network

Major academic cancer centers also run clinical trials, and your doctor’s office may have a navigator who can connect you with studies in your area.

At first glance, looking for clinical trials may seem overwhelming, but using the right search criteria, you can navigate the options and find something that’s appropriate for you.

For example, instead of just typing “bladder cancer” into the search field, Barbosa suggests that you add specific terminology that applies to you, such as “metastatic urothelial carcinoma,” “advanced bladder cancer,” or “muscle-invasive bladder cancer.” You can also search by treatment type, such as “first-line” or “after platinum treatment”; and by specific biomarkers like “FGFR,” “HER2,” and “ctDNA.”

You can narrow your search by location. Importantly, trials list if they are actively enrolling people or are closed to new participants. Make sure to select one that is actively enrolling or about to open for enrollment.

Step 3: Screen for Eligibility

Inclusion criteria may include having already undergone a specific treatment or having certain genetic information in your tumor. Exclusion criteria may be having a problem with your liver or kidneys, or being in poor physical condition.

“Eligibility criteria help researchers identify the patients most likely to benefit, minimize unnecessary risks, and reduce factors that could interfere with interpreting results,” says Barbosa. “Not qualifying for one study does not mean a patient cannot participate in another. There are often multiple trials available with different eligibility requirements.”

Talking With Your Doctor

If you’re considering a clinical trial, you will undoubtedly have many questions for your oncologist, and it’s good to take some time to write them down before your next appointment.

Experts encourage you to bring up the topic early on in your discussions about treatment.

“Patients shouldn't assume that a trial is only a last resort,” Barbosa says. “Increasingly, clinical trials are available in the first-line setting, after progression, in maintenance therapy, and even around surgery.”