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Pembrolizumab for Bladder Cancer (AMBASSADOR Trial)
AMBASSADOR Trial Summary
This trial looks at how well pembrolizumab works in treating patients with muscle-invasive bladder cancer or locally advanced urothelial cancer. Monoclonal antibodies that block the PD-1 axis can interfere with the ability of tumor cells to grow.
AMBASSADOR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAMBASSADOR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AMBASSADOR Trial Design
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Who is running the clinical trial?
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- Your hemoglobin level is 9 grams per deciliter or higher.You have received a specific type of chemotherapy before surgery, or you have certain health issues that make you ineligible for a particular type of chemotherapy, or you have chosen not to receive a specific type of chemotherapy after surgery.Your bilirubin levels are within a certain range, unless you have a condition called Gilbert's, in which case they can be a bit higher.My kidneys work well enough, with a clearance rate of at least 30 mL/min.You had chemotherapy before surgery and the cancer is at a certain stage, or you are not able to use cisplatin for treatment and the cancer is at a certain stage, or you choose not to have additional chemotherapy after surgery and the cancer is at a certain stage.I had surgery for bladder or upper tract cancer between 4 and 16 weeks ago.I do not have an active or history of severe autoimmune disease.I have certain conditions managed with creams or ointments, and my blood tests show immune system activity but no organ damage.I haven't received any live vaccines in the last 30 days.I have not received any treatment after surgery to prevent cancer return.I am 18 years old or older.I have tissue samples from my bladder cancer surgery available for testing.I had surgery for bladder or upper tract cancer between 4 and 16 weeks ago.I have no remaining cancer after surgery and had a clear bladder check if applicable.I do not have an active autoimmune disease or a history that may require steroids.I do not have active hepatitis B or C.Your blood albumin level is at least 2.8 grams per deciliter.My surgery did not leave behind visible cancer, but tiny cancer cells may remain.I have never been treated with PD-1/PD-L1 inhibitors.You have a low count of white blood cells.I am not pregnant or breastfeeding.I have not had radiation therapy in the last 4 weeks.Your AST and ALT levels are not more than 3 times the upper limit of normal.Your platelet count is at least 75,000 per cubic millimeter.I can take care of myself and perform daily activities.I have not had major surgery in the last 4 weeks.I am on hormone replacement therapy for a specific condition.I meet the initial requirements to sign up for the trial.I haven't had lung inflammation needing steroids in the last 5 years.I haven't had chemotherapy in the last 4 weeks.I am a woman who can have children and have a recent negative pregnancy test.My cancer has not spread to other parts of my body according to scans.Your absolute neutrophil count is at least 1,200 per cubic millimeter.My cancer is mainly urothelial and has invaded muscle or lymph nodes, with no neuroendocrine parts.My scans show no signs of cancer spread.I do not need hemodialysis.
- Group 1: Arm A (pembrolizumab)
- Group 2: Arm B (observation)
- 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
What do people typically use Pharmacological Study for?
"Malignant neoplasms can often be treated with Pharmacological Study. This method is also known to be effective in treating other conditions such as unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Are we still signing people up for this research project?
"This study is no longer recruiting patients. The posting for this clinical trial was on September 21, 2017 and updated on October 18, 2022. However, there are 2687 trials for patients with malignant neoplasms and 999 Pharmacological Studies that are still recruiting patients."
Are there any similar drugs that have been studied in a clinical setting before?
"The first Pharmacological Study was done in 2010 at City of Hope. So far, there have been a total of 1062 completed trials, with 999 active studies. Many of these studies are being performed out of Overland Park, Kansas."
How many individuals are currently participating in this clinical trial?
"Unfortunately, this study is no longer recruiting patients. The original posting date was September 21st, 2017, and the most recent edit was made on October 18th, 2022. There are, however, 2687 trials for patients with malignant neoplasms and 999 Pharmacological Studies that are still actively enrolling patients."
How does the safety of this Pharmacological Study compare to other similar studies?
"The safety of Pharmacological Study was given a 3 out of 3 by our Power team. This is due to this being a Phase 3 trial, where there is not only some data supporting efficacy, but multiple rounds of data supporting safety."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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