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Pembrolizumab for Bladder Cancer
Study Summary
This trial is testing a new cancer treatment. Subjects have urothelial cancer of the bladder and will be given two cycles of pembrolizumab. If they respond well to the treatment, they will continue to receive it, otherwise they will receive standard care.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- You have received radiation therapy for bladder cancer before.You had a cancer that was treated and cured, or you have low-risk prostate cancer according to specific guidelines.You have an infection that needs medication to treat.You have a history of Hepatitis B or C, but if it is resolved or in the past, you may still be eligible. If you are positive for Hepatitis C, you can still participate if a specific test is negative. Testing for Hepatitis B and Hepatitis C is only needed if local health authorities require it.You have been diagnosed with HIV. Testing for HIV is not needed unless the local health authority requires it.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.You have a history of lung inflammation that needed steroids, or you currently have lung inflammation.You have bladder cancer that has not spread to other parts of the body and specific criteria regarding the size of lymph nodes on imaging.You have had a complete surgical removal of your bladder tumor within the last 60 days, and it was done as thoroughly as possible according to your doctor. If you couldn't have the complete removal for safety reasons, you can still join the study but this needs to be discussed with the study leader.Your blood counts, kidney function, and liver function must be within a certain range. Women who can have children need to have a negative pregnancy test and agree to use birth control. Men need to agree to use contraception.You have not received chemotherapy for muscle-invasive bladder cancer before.You have had a tissue or organ transplant from someone else.You have already been treated with a certain type of medication that affects the immune system.You have a weakened immune system, or you are taking strong medication that weakens your immune system.You have an autoimmune disease that needed strong medication in the past 2 years. Hormone replacement therapy is okay.You cannot have certain types of kidney function, hearing loss, neuropathy, or heart failure that would make you ineligible for a specific type of chemotherapy.
- Group 1: Experimental Group
- 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
Are there any vacancies left in the experiment for participants?
"Clinicaltrials.gov confirms that this medical study, initially posted on July 13th 2022, is actively seeking participants. The trial's information was last edited on August 29th 2022."
What type of results is this research expected to yield?
"The primary assessment used to gauge the efficacy of this clinical trial, over a period of two years, is Benefit from Treatment. Secondary endpoints include Metastasis Free Survival (the time between initial treatment and metastatic disease), Adverse Events as per NCI CTCAE v5 standards, and Positive Predictive Value which measures how PD-L1 Expression impacts Clinical Complete Response."
What is the projected enrollment for this research project?
"Indeed, clinicaltrials.gov indicates that this experiment is actively seeking volunteers; the trial was posted on July 13th 2022 and updated lastly on August 29th of the same year. 46 participants are required from a single medical centre."
Has the FDA granted approval to Pembrolizumab?
"Pembrolizumab was determined to be relatively safe, receiving a score of 2 on our scale. This evaluation is based off the fact that this drug has not yet been approved and there exist limited clinical data confirming its safety but none supporting efficacy."
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