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Nivolumab +/− Ipilimumab Before Surgery for Bladder Cancer
Study Summary
This trial is testing if two immunotherapy drugs can help treat bladder cancer before surgery.
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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- I've had chemotherapy for bladder cancer, including treatments to boost my immune system.My bladder cancer diagnosis is mainly urothelial.I am a male willing to use contraception during and for 31 weeks after treatment.You are being held against your will for treatment of a mental or physical illness.You have a positive test for hepatitis B or hepatitis C, showing that you have an ongoing infection.I have had a stroke in the last 6 months.I have an autoimmune disease but it's under control without strong medication.I have unstable chest pain.I have had a heart attack in the last 6 months.I have a bleeding or clotting disorder but am on a stable dose of blood thinners.I haven't taken specific immune therapies for cancer, but IL-2 is okay.You are not eligible if you have moderate to severe kidney function, hearing loss, peripheral neuropathy, or if there is not enough tumor tissue available for testing. You must also be fit for surgery, be at least 18 years old, and have a certain level of physical ability.Before joining the study, your blood tests need to show specific levels of white blood cells, platelets, bilirubin, and liver enzymes. If you are taking blood-thinning medication, your dose should be consistent.I have moderate to severe heart failure.I received BCG therapy for bladder cancer less than 6 weeks ago.I have tested positive for HIV/AIDS.I am not pregnant or breastfeeding.I have a confirmed high-grade cancer in my upper urinary tract.My bladder cancer is invasive but hasn't spread beyond my bladder.I haven't had any active cancer in the last 2 years, except for early stage cancer that's been cured or doesn't need treatment.I have not had major surgery in the last 28 days, except for bladder tumor removal.I have a serious wound or fracture that is not healing.I have not had bladder radiotherapy for my muscle-invasive bladder cancer.I am using birth control during and for 23 weeks after the study.
- Group 1: Cohort 1
- Group 2: Cohort 3
- Group 3: Cohort 2
- Group 4: Cohort U (UTUC patients) is independent from Cohorts 1 - 3. ( who are cisplatin-ineligible)
- 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
Could you provide an overview of the existing research involving Nivolumab?
"Nivolumab was initially trialled in 2009 at Texas Children's Hospital, and 366 trials have been completed since. At present, 765 active clinical studies are utilizing this medication; many of these experiments taking place near Commack, New jersey."
Are there vacancies for participants in this medical experiment?
"Affirmative. According to clinicaltrials.gov, this scientific experiment is actively recruiting participants and was initially posted on April 25th 2018 with a recent update on February 1st 2022. 45 individuals need to be enrolled at 7 medical sites."
What is the current participant count for this clinical investigation?
"Correct. Information hosted on clinicaltrials.gov confirms that this medical trial is presently enrolling participants, with the initial post date being April 25th 2018 and a recent update taking place February 1st 2022. 45 patients are required from seven different locations for the study's completion."
What conditions is Nivolumab used to ameliorate?
"Nivolumab is the most common drug prescribed to patients suffering from anti-angiogenic therapy. It also has applications in treating malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
What adverse effects have been documented with Nivolumab treatments?
"With some clinical data confirming its safety, nivolumab received a score of 2. Notably, there is yet to be any evidence suggesting efficacy in humans."
How many Canadian health care sites are hosting this research initiative?
"Seven medical facilities are enrolling patients for this clinical trial. Primary sites include Memorial Sloan Kettering Commack, Memoral Sloan Kettering Monmouth and the iconic Memorial Sloan Kettering Cancer Center in New york City. The other four locations can be found on the study's official website."
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