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Atezolizumab for Bladder Cancer
Study Summary
This trial is testing how well atezolizumab works in treating patients with bladder cancer that has come back and has not responded to Bacillus Calmette-Guerin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT02008227Trial Design
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Who is running the clinical trial?
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- Any side effects from my past surgery or bladder treatments have mostly gone away.I have not had any other cancer types, except for certain allowed cases.Your blood has enough infection-fighting white blood cells.My kidney function, measured by creatinine levels or clearance, is within the normal range.You need to have had an electrocardiogram (ECG) within 42 days before joining the study.If you have HIV, you can join the study if you meet certain rules.I am not pregnant or nursing and will use birth control during and after the study.I've had a cystoscopy within the last 21 days showing no visible tumor.I haven't had bladder cancer or specific urinary tract cancer in the last 2 years and have had recent scans to check for cancer spread.I am not a candidate for or have refused the standard bladder removal surgery.I can take care of myself but might not be able to do heavy physical work.I've had a urine test for cancer cells within the last 21 days.My bladder cancer returned as high-grade after being clear for 6 months post-BCG treatment.I haven't had chemotherapy or immunotherapy for bladder cancer, nor vaccines in the last 6 weeks.I am not planning to undergo any other cancer treatments while on this trial.I haven't had a live vaccine in the last 4 weeks and won't need one during the study.I haven't had any severe infections or been hospitalized for one in the last 28 days.I had a surgery for bladder cancer less than 2 months ago and the cancer hasn't reached the muscle layer.I had surgery to remove all visible tumors within the last 60 days and can provide tissue samples.You are allergic to Chinese hamster egg or ovaries.Your platelet count is at least 100,000 per microliter within the past 42 days.Your hemoglobin level should be at least 9 grams per deciliter within the last 42 days before joining the study.My bladder cancer has returned, is not in the muscle, and was confirmed less than 60 days ago.I do not have a history of specific lung conditions.I do not have an active hepatitis B or C infection.My cancer is mainly urothelial but may have some glandular or squamous parts.I haven't taken any drugs that weaken my immune system in the last 4 weeks.I do not have active tuberculosis.My bladder cancer has not responded to BCG treatment.Your total bilirubin level needs to be within a certain range, unless you have Gilbert's syndrome, in which case it can be slightly higher.Your AST or ALT levels should not be more than two times the upper limit of normal within 42 days before joining the study.I have not had a bone marrow or organ transplant.I am not on a RANKL inhibitor or can stop it before starting atezolizumab.I have never had radiation treatment for bladder cancer.I haven't needed antibiotics for an infection in the last 14 days.I haven't needed treatment for an autoimmune disease in the last two years.
- Group 1: Treatment (atezolizumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are some of the primary conditions that Atezolizumab has been known to help with?
"Atezolizumab is most often used as small cell lung cancer (SCLC) treatment, but it has also been found to be helpful for postoperative patients and those with non-small cell lung carcinoma or other malignant neoplasms."
What are the goals that this research is looking to achieve?
"The primary outcome of this clinical trial will be the complete response (CR) rate in patients with carcinoma in situ (CIS), measured over a period of 18 months. Secondary outcomes include cystectomy-free survival, bladder cancer specific survival, and progression-free survival, all estimated using Kaplan-Meier methods."
When was Atezolizumab cleared for public use in the United States?
"Atezolizumab was given a score of 2 on Power's safety scale. This is because, although there is some data supporting the safety of Atezolizumab, no efficacy data has been collected yet as this is only a Phase 2 trial."
Are people still able to sign up for this clinical trial?
"This study is not presently looking for patients at this time. The clinical trial was first posted on 2/7/2017 and was most recently edited on 8/30/2022. If you are seeking for other studies, there are presently 2820 studies actively looking for participants with urinary bladder cancer and 356 trials for Atezolizumab actively recruiting participants."
How many different medical clinics are conducting this study?
"There are 100 sites running this study, including Saint Alphonsus Medical Center-Baker City in Baker City, Nebraska Medicine-Village Pointe in Omaha, and Ann M Wierman MD LTD in Las Vegas."
Has research like this been conducted before?
"As of now, there are 356 ongoing clinical trials testing Atezolizumab in 1665 locations and 74 different nations. The first such study began in 2008; it was sponsored by Hoffmann-La Roche and had 720 participants. After completing its Phase 2 drug approval stage, the trial concluded successfully. In total, 79 similar studies have been completed since then."
What are some similar cases to Atezolizumab in the medical literature?
"Atezolizumab was first studied in 2008, and there have been 79 completed trials since then. As of now, there are 356 active clinical trials underway. Many of these studies are based out of Baker City, Oregon."
How many people fit the requirements to participate in this clinical trial?
"Unfortunately, this trial is no longer looking for patients that match the given criteria. The study was first posted on 2/7/2017 and was most recently updated on 8/30/2022. However, there are presently 2820 studies actively searching for patients with urinary bladder cancer and 356 trials for Atezolizumab actively searching for patients."
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