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Pembrolizumab + Gemcitabine for Bladder Cancer
Study Summary
This trial is for people with bladder cancer who may need surgery. It is testing a new treatment to see if it is effective and safe.
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?
Media Library
- I can take care of myself but might not be able to do heavy physical work.I have a confirmed aggressive bladder or upper urinary tract cancer.I can provide tissue samples for cancer analysis.I have a large lymph node in my abdomen or pelvis, not biopsied but confirmed non-cancerous.I have not taken immunosuppressive drugs or steroids, except for non-cancer reasons, in the last 7 days.I am over 18 years old.My organ functions are within normal ranges as per recent tests.I haven't had a monoclonal antibody treatment in the last 28 days or have recovered from its side effects.I have been diagnosed with HIV.You have active Hepatitis B or Hepatitis C.I have a lung condition not caused by an infection.I am currently being treated for an infection.My urologist recommends a non-surgical treatment for me.My cancer is in the upper urinary tract, small, low grade, and not invasive.I have received treatment for bladder cancer before.I have another cancer, but it's either stable or treated except for skin, cervical, or low-risk prostate cancer.I have cancer that has spread to my brain or surrounding membranes.I have an autoimmune disease but it's either mild or treated with stable medications.I will use two birth control methods or avoid sex during and 120 days after the study.I have received growth factor therapy like G-CSF or GM-CSF in the last 14 days.I have been treated with specific immune-targeting drugs before.I have not received a live vaccine in the last 30 days.I agree to use barrier contraception during and for 120 days after the study.I have taken a pregnancy test that was negative within the last 3 days.My cancer is in stages 2 to 4 but hasn't spread to lymph nodes or other parts of my body.My cancer is a type of bladder cancer known as urothelial carcinoma.I am scheduled for surgery to remove my bladder or kidney as part of my cancer treatment plan.I have been on a stable dose of blood thinners like warfarin or LMWH for at least two weeks.
- Group 1: Arm B - Phase II Cohort I:
- Group 2: Arm A - Phase 1b Dose Finding Cohort:
- Group 3: Arm C - Phase II Cohort II:
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 shed light on prior experiments involving Cisplatin?
"At this time, there are 1,821 active clinical trials involving Cisplatin. Of these, 414 have reached the third phase of testing and 77605 locations around the world are running studies for this drug treatment. Notably, Shanghai accounts for a large percentage of research sites."
How many medical centers are currently conducting this trial?
"This clinical trial is now enrolling patients at various medical centres, such as Thomas Jefferson University: Kimmel Cancer Center in Philadelphia (Pennsylvania), Washington University: Siteman Cancer Center in Saint Louis (Missouri), and Indiana University Melvin and Bren Simon Cancer Center in Indianapolis (Indiana). There are 9 other locations."
How many participants are taking part in this clinical research?
"This clinical trial has ended recruitment, with the initial post being on May 27th 2015 and the last update occurring October 3rd 2022. However, those searching for other studies may be interested in 463 transitional cell carcinoma trials or 1821 Cisplatin-related ones that are currently recruiting patients."
Are there openings available to participants in this research?
"At this moment, no patients are being recruited for the trial that was initially posted on May 27th 2015 and most recently updated on October 3rd 2022. However, if you're searching for other studies to participate in, there are 463 clinical trials looking for candidates with transitional cell carcinoma, as well as 1821 Cisplatin-related medical projects actively recruiting participants."
To what maladies is Cisplatin most typically administered?
"Cisplatin is often advocated for the management of refractory, relapsed mediastinal large b-cell lymphoma. This medication can also be used to address urinary bladder cancer, advanced testicular neoplasm, and small cell lung carcinoma (SCLC)."
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