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Chemotherapy + Durvalumab for Bladder Cancer
Study Summary
This trial is testing a new cancer treatment that includes the drug durvalumab, to see if it is more effective than the current standard of care chemotherapy.
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
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Who is running the clinical trial?
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- I have not had a stroke, heart attack, or severe chest pain in the last 6 months.I am 18 years old or older.Your heart is pumping blood normally.I agree to provide tissue samples for biopsy before starting treatment.I have had an organ transplant from another person.I have another cancer that is getting worse or needs treatment.I have severe heart failure.I experience significant numbness or pain due to nerve damage.My doctor confirmed a lymph node in my pelvis can be biopsied.You have a history of a weakened immune system from birth.I have moderate to severe hearing loss.I have been treated with immunotherapy for another cancer.I haven't taken strong immune-weakening medicines in the last 28 days, except for common nasal or asthma sprays.I have previously been treated with drugs targeting PD-1 or PD-L1.I have not received a live vaccine in the last 30 days.I do not have any serious ongoing illnesses that could affect my participation in the study.I do not have an active tuberculosis infection.I haven't had bladder treatments in the last 4 weeks or have recovered from their side effects.I am not pregnant or breastfeeding and willing to use two forms of birth control for 90 days after the last dose.I do not have active Hepatitis B, Hepatitis C, or HIV.I have had an autoimmune disease in the last 2 years.My bladder cancer is at a specific stage where it has spread to nearby lymph nodes but not to distant parts of my body.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant, cannot become pregnant, and will use birth control during the study.I do not have an active infection needing IV antibiotics or a severe illness requiring hospitalization.I weigh more than 30 kilograms.Your blood, kidney, liver, and blood clotting functions are within normal levels.My cancer has spread to lymph nodes outside my pelvis or to organs.I am allergic to methotrexate, vinblastine, doxorubicin, cisplatin, durvalumab, or similar drugs.
- Group 1: Arm A: Standard of Care with dose-dense MVAC
- Group 2: Arm B: Intervention with dose-dense MVAC plus Durvalumab
- 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 participants being recruited for this research project at this time?
"The clinical trial is presently searching for patients. The study was initially posted on 10/13/2021 and was last edited on 6/2/2022."
What is the unique selling point of this clinical trial?
"Since 1997, Vinblastine has been the subject of medical research with Alfacell sponsoring the first study. The Phase 3 drug approval followed a successful trial of 300 patients in 1997. Presently, there are 1505 active trials for Vinblastine being conducted in 81 countries and across 3690 cities."
Is it dangerous to take Vinblastine?
"Vinblastine is a Phase 2 drug, meaning while there is some evidence indicating it is safe, there is currently no data to support its efficacy."
Why is Vinblastine given to patients?
"While often used to treat testicular cancer, vinblastine can also help patients with multiple sclerosis, neuroblastoma (nb), and those that have advanced directives."
How many people are taking part in this research?
"The clinicaltrials.gov website currently says that this study is looking for patients. This research was originally posted on October 13th, 2021 and the last update occurred on June 2nd, 2022. They are trying to enroll 60 individuals at a single location."
What are the historical results of other research studies that have used Vinblastine?
"There are currently 1505 different clinical trials investigating the use of vinblastine. Of these, 462 have reached phase 3. While a few of the research locations for this medication are in Shanghai, there are 77266 total sites running trials worldwide."
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