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Gemcitabine + Cisplatin + Nivolumab for Bladder Cancer
Study Summary
This trial is testing a new combination of drugs to treat bladder cancer. It is also looking at whether or not a complete response predicts benefit for patients who choose to avoid 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.Trial Design
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Who is running the clinical trial?
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- My blood counts and kidney, liver functions are within the required ranges.I have enough tissue samples from previous tests for this study.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I have no active cancers in the last 3 years, except for cured local cancers.I have had chemotherapy for bladder cancer that has spread into the muscle.I am currently on medication for an infection.I have previously received immunotherapy targeting specific immune checkpoints.You have tested positive for hepatitis B or hepatitis C, indicating you have an ongoing infection.I have an autoimmune disease but it's under control or is one of the exceptions listed.My bladder cancer is invasive but hasn't spread beyond my pelvis, and I am a candidate for surgical removal.I am a woman who can have children and have tested negative for pregnancy recently. I am under 62 and my FSH level is below 40 mIU/mL.I agree to use two forms of birth control or abstain from sex as required if I'm taking nivolumab.I can perform all my usual activities without help.I do not have severe numbness or pain from nerve damage.I have had a solid organ or bone marrow transplant.I have a lung condition not caused by an infection.I have had radiation therapy for bladder cancer.
- Group 1: Gemcitabine, Cisplatin and Nivolumab
- 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
What are the main ambitions of this experiment?
"The purpose of this two-year trial is to assess the clinical complete response rate (cT0 or cTa) when using gemcitabine, cisplatin, and nivolumab in combination. Additionally, the research team will observe Adverse Events according to NCI CTCAE v4 guidelines as well as establish a correlation between preselected genomic biomarkers and patient benefit from treatment who achieved a clinical complete response. Finally, they seek to measure Recurrence-free survival which starts with initial treatment until death or recurrence occurs first."
Has the Food and Drug Administration sanctioned Gemcitabine for use?
"Our experts at Power graded gemcitabine's safety a 2 out of 3, as Phase 2 trials are typically able to provide an indication of the medication's security. However, empirical evidence is still required to verify its efficacy."
Are there numerous healthcare centers in North America conducting this experiment?
"Currently, there are 7 recruitment sites for this particular trial; these include Philadelphia, Salt Lake City and New york as well as 4 other cities. It is advisable to select the nearest location in order to reduce travel-related issues if you choose to participate in the study."
What is the total number of participants being recruited for this clinical research?
"At the present, this clinical trial is not seeking participants. Initially posted on July 13th 2018 and last edited on July 7th 2022, patients are directed to other trials recruiting for bladder cancer or Gemcitabine-related studies. Currently, 373 research projects are open for enrollment in relation to cancer while 1638 investigations revolve around Gemcitabine specifically."
Have there been any former experiments conducted involving Gemcitabine?
"Gemcitabine was initially researched in 1997 at City of Hope Comprehensive Cancer Center. As such, eighteen hundred and forty-eight clinical trials have been concluded thus far with sixteen hundred thirty-eight active trials occurring mainly in Philadelphia, Pennsylvania."
Is enrollment still ongoing for this clinical experiment?
"According to clinicaltrials.gov, this trial is no longer attempting to recruit patients as the last edited date was July 7th 2022; however, 2011 other studies are still actively searching for participants at present time."
What pathologies can be addressed through the administration of Gemcitabine?
"Gemcitabine has demonstrated efficiency in treating testicular cancer, as well as malignant neoplasms, small cell lung (SCLC) tumours and unresectable melanomas."
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