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Pembrolizumab + Gemcitabine + Radiation for Bladder Cancer
Study Summary
This trial is to see if adding pembrolizumab to radiation and gemcitabine helps people with muscle-invasive urothelial cancer who are not candidates for or decline radical cystectomy.
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 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I have an active tuberculosis infection.I am using two birth control methods or am not able to have children, and will continue for 120 days after the study.I am currently being treated for an infection.I have a history of inflammatory bowel disease or scleroderma.You currently have active Hepatitis B or C.My bladder cancer is at a specific stage but hasn't spread to lymph nodes or other parts.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks or still have side effects from them.I have an autoimmune disease treated with medication in the last 2 years.I have taken a pregnancy test within the last 72 hours and it was negative.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I am willing to provide a bladder cancer tissue sample if needed.I cannot or will not undergo major bladder surgery as advised by my cancer doctor.My bladder cancer was confirmed by a biopsy within the last 2 months.I have not received a live vaccine in the last 30 days.I have a history of inflammatory bowel disease or scleroderma.I have a history of or currently have non-infectious lung inflammation.I have had radiation therapy to my pelvic area before.I have been diagnosed with HIV.My organ functions are within normal ranges as required.You are allergic to pembrolizumab or any of its ingredients.I am 18 years old or older.I have fully recovered from any major surgery before starting treatment.You have had Guillain-Barre Syndrome or Stevens-Johnson Syndrome in the past.I agree to use birth control during and for 4 months after the study treatment.I have had treatments like chemotherapy for bladder cancer before.I haven't had cancer in the last 5 years, except for certain skin cancers or early-stage prostate cancer.I am fully active or restricted in physically strenuous activity but can do light work.
- Group 1: Pembrolizumab, Gemcitabine, and RT
- 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
In which locales can one find access to this clinical trial?
"At the moment, 5 sites are in recruitment mode. These locations include Chicago, Chapel Hill and Ann Arbor - as well as 2 other places. To reduce travel-related strain on enrolled patients, it is beneficial to choose a trial site close to your residence."
Have any other trials been conducted on the efficacy of Pembrolizumab?
"Presently, there are 1368 active studies investigating pembrolizumab with 244 of them being in Phase 3. Primarily taking place in Shanghai, these medical trials for pembrolizumab span across 54125 sites globally."
What is the current cohort size for this experiment?
"This particular trial has ceased its recruitment process; the original posting was on August 11th 2016 and it last underwent changes on December 1st 2021. If you are seeking other options, there are 314 research initiatives actively recruiting patients suffering from urinary bladder issues and 1368 trials for Pembrolizumab that have open vacancies."
In what patient populations is pembrolizumab typically used?
"Pembrolizumab is an appropriate treatment for malignant neoplasms, as well as many other medical conditions such as unresectable melanoma, microsatellite instability high and non-small cell lung carcinoma."
Can you provide data on the safety of Pembrolizumab for individuals?
"Because of the Phase 2 trial data, which shows some safety but no efficacy evidence, our team at Power assigned Pembrolizumab a score of 2."
Is there currently an opportunity to apply for this research study?
"A perusal of clinicaltrials.gov reveals that this trial, which was originally listed in August 2016 and last updated on December 1st 2021 is not currently recruiting any more participants. However, there are over 1600 other medical trials actively seeking patients at the moment."
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