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Durvalumab +/- Tremelimumab for Bladder Cancer
Study Summary
This trial is testing a new immunotherapy drug, MEDI4736, to see if it can improve survival in patients with stage IV urothelial 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 2022 Phase 3 trial • 867 Patients • NCT03084471Trial Design
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Who is running the clinical trial?
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- I have previously received immunotherapy or vaccines for cancer, but not within the last 28 days.My brain or spinal cord cancer is stable, and I haven't taken steroids for over 2 weeks.I do not have active infections like TB, hepatitis B, C, or HIV.My tumor's PD-L1 status has been confirmed by a lab test.I haven't taken strong immune system suppressing drugs in the last 14 days, except for minor exceptions like inhalers or small doses of steroids.I have Stage IV bladder cancer that hasn't been treated with first-line chemotherapy.I am either eligible or not for cisplatin chemotherapy based on specific health conditions.I haven't had any live vaccines in the last 30 days.I have had an organ transplant and take drugs to suppress my immune system.
- Group 1: Monotherapy
- Group 2: Standard of Care
- Group 3: Combination Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there any known dangers associated with MEDI4736 (Durvalumab)?
"MEDI4736 (Durvalumab) has been evaluated for safety and given a score of 3."
If a person is below a certain age, can they not participate in this research?
"In order to participate in this study, patients must between 18-130 years old. Out of the 2,887 total clinical trials, 125 are for patients under 18 and 1637 are for patients over 65."
For what purpose is MEDI4736 (Durvalumab) most often administered?
"MEDI4736 (Durvalumab) can be used to treat patients that have yet to receive treatment, those that have received adjuvant anthracycline-based therapy, and patients with active disease."
Are there many case studies of MEDI4736 (Durvalumab)'s efficacy?
"MEDI4736 (Durvalumab) was first studied over two decades ago in 1997. Since then, there have been a total of 2345 completed trials. At the moment, 1695 clinical trials are ongoing, a significant number of which are based in Halifax, Nova Scotia."
Are there different sites where I can participate in this trial?
"There are 27 sites running this study currently. Locations include Halifax, Calgary, Vancouver and a few other places. If you enroll, it may be helpful to choose the site nearest you to cut down on travel."
Are there any patients who have yet to join this trial?
"This particular clinical trial is no longer seeking patients. The trial was initially posted on November 2nd, 2015 and had its last update on November 2nd, 2022. For individuals interested in other trials, 31 different studies are actively recruiting patients with urothelial cancer and 1695 studies are actively admitting patients for MEDI4736 (Durvalumab)."
Could I participate in this research project if I qualify?
"This study is looking for 1126 participants of all ages who currently have urothelial cancer. In order to be eligible, patients must meet the following criteria: histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma of the urothelium and have not been previously treated with first-line chemotherapy; patients eligible or ineligible for cisplatin-based chemotherapy; creatinine clearance (calculated or measured) <60 mL/min calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection for determination; CTCAE Grade ≥2 audiometric"
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