Your session is about to expire
← Back to Search
Radiation Therapy + Durvalumab ± Tremelimumab for Bladder Cancer
Study Summary
This trial is testing radiation therapy with or without two different drugs to treat 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.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- Your bilirubin levels in the blood should not be higher than 1.5 times the normal limit, unless you have a specific condition called Gilbert's syndrome, in which case you can still participate after talking to your doctor.My liver function tests are within the required range.I have a history of autoimmune disease.I do not have any serious ongoing illnesses that my doctor is not able to control.Your platelet count is at least 100,000 per cubic millimeter.I have limited self-care and spend more than half of my waking hours in bed or a chair.I have HIV or hepatitis but meet the specific conditions for study participation.I haven't had major surgery in the last 28 days, except for a biopsy or specific bladder tumor removal.I have had surgery or radiation therapy for bladder cancer.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.I have had radiation therapy to my abdomen or pelvis area before.Your heart's electrical activity, called the QT interval, is longer than normal. If this is the case, multiple ECG tests will be done to confirm.I have had cancer spread to the lining of my brain and spinal cord.I am not pregnant or breastfeeding and agree to use birth control during and after treatment.You are expected to live for at least 12 more weeks.I agree to provide a recent tumor sample or undergo a biopsy for the study.I cannot or choose not to receive cisplatin-based chemotherapy due to health reasons or personal choice.I don't have active autoimmune or severe inflammatory disorders.I am not on cancer treatment drugs, but hormones for other conditions are okay.I had cancer before, but it was either treated over 3 years ago, was a non-melanoma skin cancer, or was an early stage cancer that's been treated.I haven't had any live vaccines in the last 30 days.I have a bladder tumor that hasn't been removed and causes symptoms, suitable for radiation therapy.My brain metastases are stable, and I haven't used steroids for 14 days.I have seizures that are not controlled by medication.My bladder cancer is advanced but hasn't been treated with cystectomy.I have a tumor that can be measured and has not been treated with radiation.I am fully active or can carry out light work.I haven't taken strong immune-suppressing drugs in the last 14 days, except for low-dose steroids or inhalers.My kidney function, measured by creatinine clearance, is good.I do not have an active infection, including tuberculosis.I am not able to have children, or I have tested negative for pregnancy.I am willing and able to follow the study's treatment and visit schedule.You have a history of a weak immune system from birth.You have had a bad reaction to durvalumab or tremelimumab before.Your hemoglobin level is at least 9.0 grams per deciliter.I am allergic to durvalumab and tremelimumab.You have enough infection-fighting white blood cells.
Frequently Asked Questions
What conditions has Tremelimumab been demonstrated to be efficacious in treating?
"Tremelimumab is an effective treatment option for individuals battling unresectable stage III non-small cell lung cancer, untreaded metastatic urothelial carcinoma and other forms of the disease."
What is the primary goal of this medical study?
"This clinical trial has the primary objective of assessing progression-free survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 over a 90 day period after the last dose of the investigational product is administered. Secondary outcomes include overall survival, overall response rate (ORR), and abscopal response for patients with metastatic disease, all determined by RECIST v 1.1. Further analysis will use two-sample proportion tests to ascertain if there is any meaningful difference between arms when accounting for stratification design using Cochran-Mantel-Haenszel methodology."
What evidence exists that demonstrates Tremelimumab's efficacy in medical applications?
"At present, 340 independent trials are actively exploring Tremelimumab with 52 of those studies at Phase 3. Of the 13083 trial sites looking into this drug, many are centered in Cordoba, Texas."
Has Tremelimumab received federal authorization for use?
"Our team at Power gauged the safety of tremelimumab to be a 2, given its Phase 2 status. There is some evidence that it may pose no risk but there has yet to be any proof for efficacy."
What is the scope of enrollment for this research project?
"This medical trial is presently not recruiting new patients. The investigation was first opened on October 26th 2018 and has been updated most recently on December 2nd 2021. If you are looking for alternative studies, 321 clinical trials are actively enrolling individuals with urinary bladder cancer while 340 ongoing investigations seek to include participants in a study of Tremelimumab."
Is this a novel experiment in medical research?
"Presently, Tremelimumab is being tested in 340 clinical trials spread across 58 countries and 1327 cities. AstraZeneca sponsored the first study for this drug back in 2007 which included 37 patients and concluded its Phase 2 approval process. Subsequently, 138 studies have been completed over the last 14 years."
Are individuals currently able to enlist in this clinical trial?
"According to clinicaltrials.gov, the recruitment period for this study has ended, as it was last updated on the 2nd of December 2021. Initially posted on October 26th 2018, 661 other trials are now actively searching for participants instead."
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger