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Nivolumab for Prostate Cancer
Study Summary
This trial is testing whether or not the drug is effective in treating prostate 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 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
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Who is running the clinical trial?
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- My PSA is rising, and I have no cancer spread on scans. My PSA doubles in less than 10 months.My PSA levels double in less than 10 months.My PSA levels are rising and are above 1.0 after prostate surgery.I am taking more than 10 mg of prednisone or equivalent daily for another health issue.I have been treated with immune checkpoint inhibitors before.- You must have tissue samples available for testing, either from a prostatectomy or biopsy.
- You must consent to genetic testing performed on this tissue.
- You must be at least 18 years old and have adequate organ and marrow function.
- You must have a certain level of blood counts and normal kidney and liver function.
- You must have a testosterone level of at least 100 ng/dL.
- You must have recovered from any toxicity related to prior treatment or have no treatment-related toxicity greater than grade 2.
- Having a history of other cancer is not a problem as long as it's stable and doesn't require treatment.
- You must be able to understand and follow study procedures.
- Male patients with female partners of reproductive potential must agree to use contraception during the trial period.I have not had major surgery or radiation within the last 2 weeks.I have another cancer type, but it's stable and doesn't need treatment.I agree to use contraception during the trial if my partner can become pregnant.I have an autoimmune disease but it's not currently severe or requiring strong medication.I am fully active or can carry out light work.I am 18 years old or older.My blood counts meet the required levels.My liver is functioning properly.I have recovered from major side effects of my previous cancer treatments.I had prostate cancer confirmed by biopsy and treated with surgery or radiation.I had prostate cancer confirmed by biopsy and treated with surgery or radiation.I haven't taken any prohibited medications, including cancer treatments, in the last 4 weeks.I have provided tissue samples for advanced genetic testing.I am currently using or plan to use hormone therapy for my cancer during the trial.My total bilirubin is less than 3.0 mg/dL, and I may have Gilbert Syndrome.My organs and bone marrow are working well.My biopsy showed cancer in at least 3 tissue samples.My kidney function is within the required range.
- 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 extent of Nivolumab's research history?
"Nivolumab was first studied a decade ago, in 2010, at the H. Lee Moffitt Cancer Center and Research Institute. So far, there have been 249 completed trials with 747 more still underway. A large concentration of these active clinical trials are based in South Weymouth, New hampshire."
How many willing test subjects are there for this experiment?
"That is accurate. The clinicaltrials.gov website contains information revealing that this study is currently looking for 34 patients at 5 sites. This trial was originally posted on 10/18/2018 and was most recently edited on 5/16/2022."
Are people with the qualifying condition still able to join this research project?
"That is correct, the online clinicaltrials.gov registry currently lists this study as open and recruiting new patients. This trial was first posted on October 18th, 2018 and was last updated more recently on May 16th, 2022. A total of 34 individuals are needed for this research project taking place at 5 different hospitals or clinics."
Have other research groups looked into this intervention before?
"Nivolumab is being studied in 747 active clinical trials, which began as early as 2010. The first study, sponsored by Medarex, completed Phase 1 drug approval with 127 patients. In the 10 years since then, 249 more trials have been conducted."
What is Nivolumab's typical therapeutic application?
"Nivolumab has applications in the treatment of both cancerous and non-cancerous neoplasms. For example, it can be used to treat metastatic melanoma, squamous cell carcinoma, and unresectable esophageal adenocarcinoma."
What is the Nivolumab FDA approval status?
"Nivolumab is a Phase 2 medication, meaning that while there is some evidence confirming its safety, none exists to show that it is an effective treatment."
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