Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer

Investigating the Effectiveness of an Investigational Medication in Recurrent Non-Muscle Invasive Bladder Cancer

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back and has not responded to treatment with Bacillus Calmette-Guerin (BCG).

Detailed description of study

The purpose of this study is to estimate complete response at 25 weeks after registration for those with a carcinoma in situ (CIS) component and to evaluate event-free survival at 18 months in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (Ta/T1/CIS) treated with atezolizumab.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: bladder cancer
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patients must have histologically proven, recurrent, non-muscle invasive urothelial carcinoma of the bladder within 60 days prior to registration; the carcinoma must be stage T1 high-grade, stage CIS, or stage Ta high-grade
  • Patients with mixed urothelial carcinoma and a glandular and/or squamous component will be eligible for the trial, but the presence of other histologic variants, pure adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligible

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1804004016 (S1605)

This study investigates the effectiveness of an investigational medication for patients with non-muscle invasive bladder cancer that has returned and not responded to previous treatment. Non-muscle invasive bladder cancer is a type of cancer that affects the inner lining of the bladder but does not penetrate the bladder muscle. The study aims to measure the complete response of patients at 25 weeks after enrollment and evaluate event-free survival at 18 months.

Participants in this study will receive the investigational medication and will be monitored for their response to the treatment. Event-free survival means the length of time after treatment during which the patient remains free from certain complications or events that the study is measuring. The study does not involve payment for participation.

  • Who can participate: Adults with recurrent, non-muscle invasive bladder cancer that is stage T1 high-grade, stage CIS, or stage Ta high-grade may be eligible. Patients must have a diagnosis within 60 days prior to enrollment. Those with mixed urothelial carcinoma and glandular or squamous components are eligible, but not those with pure adenocarcinoma or pure squamous cell carcinoma.
  • Study details: Participants will receive an investigational medication. The study aims to assess how well the medication works in preventing cancer recurrence and improving survival without events.

Find a site

Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact label
Race
Ethnicity
Other language

Default Content Message Here