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Atezolizumab + Chemotherapy for Bladder Cancer
Study Summary
This trial will compare the effects of atezolizumab when given before or after standard chemotherapy drugs in patients with advanced bladder cancer.
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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- I haven't had cancer treatment in the last 3 weeks.I have not had any other cancers in the last 5 years.I have been treated with drugs targeting PD-1 or PD-L1.I haven't taken any immune-boosting drugs in the last 6 weeks.I have a brain tumor or cancer that has spread to my brain and causes symptoms.My heart condition severely limits my daily activities.I have moderate to severe numbness, tingling, or muscle weakness.I have moderate to severe hearing loss.I am fully active or can carry out light work.I have a history of lung scarring or inflammation.I have a bone marrow disorder that may affect my treatment.I have not had major surgery in the last 28 days.I have not received a live vaccine in the last 4 weeks.I have a history of HIV or active hepatitis B or C.I have not had severe infections in the last 4 weeks.I have not had signs of infection in the last 2 weeks.I have taken antibiotics by mouth or IV within the last 2 weeks.My cancer is confirmed to be mainly urothelial and affects my bladder, ureter, urethra, or renal pelvis.My cancer is advanced or has spread to other parts of my body.I am 18 years old or older.My cancer can be measured and biopsied according to specific guidelines.My blood and organs are functioning well.I haven't taken any immune-weakening medications in the last 2 weeks.I have had a bone marrow or organ transplant in the past.I agree to have two biopsies for research during my treatment.I have enough tumor tissue available for PD-L1 testing.I have active tuberculosis.I am taking bisphosphonates for high calcium levels.I do not have any health issues that prevent me from taking experimental medications.I have a serious liver condition.I have had chemotherapy or immunotherapy for bladder cancer that has spread.
- Group 1: Atezolizumab alone with Gemcitabine and Cisplatin
- Group 2: Atezolizumab with Gemcitabine and Cisplatin
- Group 3: Atezolizumab alone for 1 cycle prior to gemcitabine, cisplatin
- 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
Atezolizumab is often administered to treat which condition?
"Atezolizumab can be administered as a treatment to patients with urinary bladder, advanced testicular cancer, and small cell lung cancer (sclc)."
Are new patients still being sought for this clinical trial?
"Although this study is no longer recruiting patients, that information found on clinicaltrials.gov, it was last updated on 7/11/2022. There are 1553 other trials that are currently looking for patients to enroll."
Are there different sites where I can participate in this research?
"There are 9 recruitment sites for this trial, including Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown, Memorial Sloan Kettering Bergen in Montvale, and Memorial Sloan Kettering Westchester (Limited Protocol Activities) in Harrison."
What is the government organization's opinion of Atezolizumab?
"Atezolizumab has undergone Phase 2 clinical trials, meaning that while there is some evidence of its safety, none exists for its efficacy. Our team at Power have given it a rating of 2."
Can you tell me if Atezolizumab has been studied before?
"Atezolizumab was first researched in 1997 at City of Hope Comprehensive Cancer Center. So far, there have been 1686 completed trials on this medication. Furthermore, there are 1323 active studies, with a large concentration of these occurring near Middletown, New jersey."
What is the projected scope of this clinical trial?
"Unfortunately, this particular clinical trial is no longer seeking participants. The study was first posted on 3/22/2017 but the most recent update occurred on 7/11/2022. However, there are many other trials that may be of interest; at the moment, 230 trials involving patients with unresectable and 1323 Atezolizumab trials are admitting new participants."
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