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Atezolizumab + Cisplatin + Gemcitabine for Bladder Cancer
Study Summary
This trial is testing whether adding atezolizumab to gemcitabine and cisplatin chemotherapy is safe and whether it works better than gemcitabine and cisplatin alone for treating pancreatic cancer.
Timeline
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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- I have had chemotherapy before.You have a low count of a certain type of white blood cells called neutrophils.You have a sufficient amount of a type of white blood cell called lymphocytes.Your hemoglobin level is at least 9.0 grams per deciliter.You are allergic to Chinese hamster ovary cell products or any part of the atezolizumab medication.I have had a stem cell or organ transplant in the past.I have not received BCG treatment in the last 4 weeks.My cancer is confirmed as urothelial carcinoma by a lab test.My cancer is either locally advanced or has spread to other parts of my body.I am a woman who can have children and my pregnancy test is negative.I have a history of lung scarring or inflammation.I do not have an active or untreated brain tumor or cancer spread to my brain.I haven't taken any immune-weakening medications in the last 2 weeks.Your bilirubin levels are within a certain range, unless you have Gilbert's disease, in which case they can be a bit higher.I agree to have two biopsies for research during my treatment.You need to provide a sample of your bladder cancer tissue for testing.I have severe heart disease that limits my daily activities.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I have moderate to severe numbness or pain in my hands or feet.I am not pregnant or breastfeeding and agree to use contraception during and 5 months after treatment.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.I am not taking any medications that would exclude me from the trial.I have not used any experimental drugs in the last 4 weeks.I haven't had any cancer treatment in the last 3 weeks.I have had chemotherapy or immunotherapy for bladder cancer that has spread.I am 18 years old or older.My cancer can be measured and has a part that can be safely biopsied.My doctor agrees I can undergo major bladder surgery.I have moderate to severe hearing loss.I do not have any serious ongoing health or mental health conditions.I have HIV/AIDS.I have active hepatitis B or C.I have a significant liver condition, such as hepatitis or cirrhosis.You have had serious allergic reactions to certain types of medications made from antibodies or proteins.I haven't had any cancer other than my current one in the last 5 years.I have been treated with specific immune therapy drugs before.I have had radiation therapy targeted at my bladder.My blood clotting tests are normal or I am on a stable dose of blood thinners.You are expected to live for at least 12 weeks.I haven't had a heart attack, stroke, or severe heart issues in the last 6 months.I have a heart rhythm problem, but it's controlled or treated.I do not have active tuberculosis or a BCG infection.I have had lung inflammation from past radiation, but it's now scar tissue.You cannot be participating in another clinical trial that involves getting medical treatment, but trials that focus on improving quality of life or providing supportive care are okay.You have had a disease where your immune system attacks your own body.I haven't taken any antibiotics by mouth or IV in the last 2 weeks.My side effects from cancer treatment are mild, except for hair loss.I am taking bisphosphonates for high calcium levels due to cancer.I have a bone marrow disorder that may affect my treatment.I have skin conditions like eczema or psoriasis, but only on my skin.I am fully active or can carry out light work.I haven't taken any immune-boosting drugs in the last 6 weeks.You need to have at least 100,000 platelets per cubic millimeter of blood.Your AST and ALT levels are not more than 3 times the upper limit of normal for the testing center.Your alkaline phosphatase level is not more than 2.5 times the upper limit of normal for the institution.My bladder cancer has been confirmed to invade muscle, or it's in the prostate but confirmed by imaging.My cancer is in a localized stage but has grown beyond the original site.Your kidney function is good with a filtration rate of at least 60 ml/min/1.73m2.
- Group 1: Atezolizumab, Gemcitabine, Cisplatin
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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
How has Atezolizumab proven efficacious in treating various ailments?
"Atezolizumab is a viable treatment for advanced testicular cancer, urinary bladder issues, and small cell lung cancer (SCLC)."
Is there prior evidence of Atezolizumab's efficacy?
"Atezolizumab was first investigated in 1997 by City of Hope Comprehensive Cancer Center. To date, 1692 studies have been finished and 1279 are still ongoing; many of these experiments take place at a lab located in Basking Ridge, New jersey."
How many participants are currently undergoing this research?
"The deadline for this trial has passed. Initially posted on December 20th 2016 and last edited November 23rd 2022, the project is no longer seeking enrollees. However, there are currently 520 trials recruiting individuals with bladder cancer and 1279 studies looking to add participants using Atezolizumab therapy."
Is it currently possible to enroll in this research endeavor?
"Per the details on clinicaltrials.gov, this research is no longer recruiting participants. This trial was first listed in December 2016 and last updated in November 2022; however, there are still 1799 other studies that have open enrollment at present."
How many venues are supporting the implementation of this experiment?
"Currently, 11 different medical sites are running this trial. These locations include Basking Ridge, Uniondale and New york City plus 8 others. It is recommended that participants select the nearest clinic to reduce travel requirements."
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