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Bladder cancer drugs under the microscope: do they work in everyday practice?

NCT ID NCT07207928

Knowledge-focused Sponsor: Azienda Ospedaliera Universitaria Integrata Verona Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study followed 35 adults with advanced urothelial (bladder) cancer who had stable disease after initial chemotherapy. They received either Avelumab as first-line maintenance therapy or Pembrolizumab as second-line therapy. Researchers tracked how long the cancer stayed under control, side effects, and costs over 12 months, with up to 10 years of past data. The goal is to see how these drugs perform in real-world settings, outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Avelumab and Pembrolizumab
What this could lead to
If successful, this study could provide real-world evidence on the effectiveness and cost of these immunotherapies, helping doctors make better treatment decisions for advanced bladder cancer.
What could go wrong
This is a small observational study (35 people) that looks back at past data and follows patients for only 12 months. It cannot prove cause and effect, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

35 people

The number who actually took part.

Started

Sep 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with advanced urothelial cancer without disease progression after 4-6 cycles of first-line platinum-based chemotherapy

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * At least 18 years of age * ECOG PS 0-2 * Diagnosis of pathologically confirmed stage IV urothelial cancer, regardless of PD-L1 status * Patients treated with platinum-based chemotherapy (Cisplatin or Carboplatin) in the first-line setting who have not shown disease progression after 4-6 cycles of chemotherapy * Patients receiving Avelumab as maintenance therapy in the first-line setting or Pembrolizumab in the second-line setting * Availability of hospital and/or outpatient medical records for clinical data collection * Ability to understand and willingness to provide informed consent, or deceased patients at the time of enrollment, in compliance with Article 110 of the Privacy Code and the safeguards established by the Data Protection Authority in Provision No. 298 of May 9, 2024. Exclusion Criteria: * History of another malignancy or concurrent malignancy (except for cured non-melanoma skin cancer, low-risk prostate cancer, T1/T2 glottic cancer, stage 0 or I breast cancer, non-invasive bladder cancer, or in situ cervical cancer).

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Conditions

The condition(s) this trial relates to.

urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urothelial cancer

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona, Verona, 37134, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.