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Avelumab + Taxane for Bladder Cancer
Study Summary
This trial is testing the safety and effectiveness of combining two drugs, Avelumab and Docetaxel, to treat patients with metastatic 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 2014 Phase 4 trial • 32 Patients • NCT01301729Trial Design
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Who is running the clinical trial?
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- I am currently receiving treatment for cancer.I have been treated with drugs that target immune system proteins.I have not had major surgery in the last 4 weeks or am fully recovered if I did.I am mentally capable of understanding and giving informed consent.My bladder cancer got worse after platinum treatment or I couldn't have cisplatin.My blood test results are within the normal range.My kidneys work well enough, with a creatinine clearance over 30 mL/min.I haven't taken steroids, immunosuppressants, or experimental drugs in the last 28 days.I have lasting side effects from past treatments, but only mild ones except for some nerve issues.I do not have severe chronic conditions like immune colitis or psychiatric issues.I have not received any vaccines within 4 weeks before starting Avelumab, except for inactivated ones.I am fully active or can carry out light work.My liver is functioning well, according to recent tests.I haven't had cancer, other than bladder cancer, in the last 5 years.I am between 18 and 85 years old.I have had an organ or stem-cell transplant.I have or had an autoimmune disease or immune deficiency.I am willing to use effective birth control during and for 30 days after the study.My cancer is mainly urothelial and has spread beyond where it started.I have a serious heart condition.I have active brain tumors.
- Group 1: Avelumab and Docetaxel
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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
What is the magnitude of enrollment into this experiment?
"At the present moment, this medical trial is not accepting patient participants. It was first opened on October 29th 2018 and last modified on October 18th 2022. However, if one is searching for other clinical studies, there are 214 trials related to carcinoma transitional cell recruiting candidates as well as 430 trials involving docetaxel actively seeking individuals."
Has the U.S. Food and Drug Administration given their stamp of approval to Docetaxel?
"An assessment of the safety profile for Docetaxel revealed a score of 1, indicating that this is an early-phase trial with limited evidence supporting its effectiveness and risk mitigation."
Has Docetaxel been the focus of any prior research initiatives?
"At the moment, there are 430 ongoing studies researching Docetaxel. Of those active trials, 136 have advanced to Phase 3 status. While Fuzhou, Fujian is home to a majority of these experiments, 26 066 clinical sites around the world are evaluating this treatment option."
Are there any available slots for participants in this trial?
"As of October 18th 2022, this clinical trial is no longer accepting new candidates. It was initially posted on October 29th 2018 and has since been edited multiple times. However, there are currently 214 trails for carcinoma transitional cell patients seeking participation as well as 430 studies involving docetaxel actively recruiting participants."
To what end is Docetaxel typically employed?
"Docetaxel is commonly used to tackle soft tissue sarcomas, and it has proven useful for treating other pathological processes such as neoplasm metastasis, BRCA1 gene mutations, and advanced directives."
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