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Nivolumab for Bladder Cancer
Study Summary
This trial is testing whether two immunotherapy drugs or one immunotherapy drug plus surgery is more effective than surgery alone in treating participants with high-risk urothelial cancer who cannot receive cisplatin chemotherapy.
- Bladder Cancer
- Bladder Tumors
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 • 541 Patients • NCT02041533Trial Design
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Who is running the clinical trial?
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- You have a history of blood clots in your lungs (pulmonary embolism), deep veins (deep vein thrombosis), or other significant blood clot-related events.You cannot receive cisplatin as a treatment option if you meet any of the following criteria:
- Group 1: Arm B: Monotherapy
- Group 2: Arm C: Standard-of-care
- Group 3: Arm A: 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
Does Nivolumab carry a high risk for serious side effects?
"Nivolumab has been deemed safe by our team at Power. This is due to the fact that Nivolumab is a Phase 3 trial, meaning that not only is there some data supporting efficacy, but multiple rounds of data supporting safety."
In how many different medical facilities is this research being conducted today?
"34 hospitals around the world are participating in this clinical trial, including Banner MD Anderson Cancer Center in Gilbert, Arizona, Local Institution - 0082 in Oshawa, Ontario, and Rutgers Cancer Institute of New jersey in New Brunswick, New Jersey."
Are there any vacancies in this study for potential participants?
"This study has already wrapped up recruitment for participants. The trial was first posted on February 5th, 2020 and was most recently edited on October 10th, 2022. If you are looking for other studies, 391 clinical trials for patients with muscle-invasive bladder cancer and 753 studies for Nivolumab are currently recruiting."
Could you please tell us if Nivolumab has been studied before?
"Out of the 753 ongoing studies involving Nivolumab, 83 are in Phase 3. The global locations conducting these trials number 40502, with many of them situated in São Paulo and Maryland."
Why is Nivolumab commonly given to patients?
"Nivolumab is used to treat malignant neoplasms and other conditions such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
How many volunteers are included in this experiment?
"This particular trial is no longer taking patients. The trial began on 2020-02-05 and ended on 2022-10-10. However, there are currently 391 trials for muscle-invasive bladder cancer and 753 trials for Nivolumab that are actively recruiting participants."
Has a trial like this been conducted before?
"Nivolumab has a long history, with the first clinical trial being conducted in 2010. The original study was sponsored by Medarex and only involved 127 patients. Phase 1 drug approval was given to Nivolumab in 2010. Currently, there are 753 active studies being conducted in 2357 cities and 50 countries."
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