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Pembrolizumab + Entinostat for Bladder Cancer
Study Summary
This trial is testing a new cancer treatment combining immunotherapy with a class I HDAC inhibitor. The goal is to see if the treatment changes immunogenomic markers in patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based neoadjuvant chemotherapy.
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 am taking medication that affects P-gp for my treatment.I have an active tuberculosis infection.I have had chemotherapy for bladder cancer before.I am a woman who can have children and have a recent negative pregnancy test.I have a history of Hepatitis B or C.I am allergic to pembrolizumab or its components, and if in arm 2, also to benzamide or entinostat's inactive ingredients.I have another cancer besides the one being studied, but it's not getting worse or needing treatment, except for certain skin cancers or cervical cancer that's been treated.I have previously been treated with specific immune system targeting drugs.My bladder cancer diagnosis includes urothelial carcinoma.My bladder cancer is at a stage where it has grown but not spread to distant parts.I can take and keep down pills.I have had radiation therapy on my bladder for cancer treatment.I am 18 years old or older.I have an immune system disorder or have been on immune-weakening medication recently.I have not received a live vaccine in the last 30 days.You are expected to live for at least 3 more months.I am scheduled for a surgery to remove my bladder.I use medication or supplements that are affected by certain liver enzymes.I can take care of myself and am up and about more than half of my waking hours.I cannot or choose not to receive cisplatin-based chemotherapy due to my health condition.I have a preserved tumor sample that can provide 15 to 20 slides for testing.I have a gut condition that affects how my body absorbs medication.I agree to donate tissue from my bladder surgery and blood before and at the time of my surgery.I am currently taking medications that affect cell DNA, like valproic acid.I have been diagnosed with HIV.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am a man who can father children and agree to use birth control as required, starting with the first dose of study therapy through 120 days after the last dose.My organ functions are within normal ranges as required.I have had pneumonitis treated with steroids or have it now.I am currently being treated for an infection.
- Group 1: A: Pembrolizumab alone
- Group 2: B: Pembrolizumab plus Entinostat
- 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 inform me of the additional experiments related to Pembrolizumab?
"Pembrolizumab was first studied at Johns Hopkins University/Sidney Kimmel Cancer Center in 2009 and there are now 281 concluded studies. Currently, 974 live clinical trials of this medication exist; many of which take place in Philadelphia, Pennsylvania."
Is the research team currently recruiting participants?
"Affirmative. According to the information located on clinicaltrials.gov, this study is currently recruiting participants with an initial posting date of September 23rd 2020 and most recent update from October 10th 2022. It requires 20 subjects at two sites for enrolment."
What is the current cap on enrollees for this clinical trial?
"Affirmative. Clinicaltrials.gov details that this medical trial, initially posted on September 23rd 2020, is actively searching for participants. Up to twenty patients are sought from two clinical sites."
Has the Federal Drug Administration sanctioned Pembrolizumab?
"After careful assessment, the safety of Pembrolizumab was rated a 2 on the 1-3 scale. This is because only preliminary evidence exists to support its efficacy and there is some data suggesting it can be safely administered in medical trials."
To what conditions is Pembrolizumab usually prescribed?
"Pembrolizumab is primarily employed to fight cancerous tumors, but it may also be used for issues like unresectable melanoma, microsatellite instability high, and chemotherapy-resistant disease progression."
Do I qualify to partake in this research project?
"This clinical trial is currently recruiting 20 participants with bladder cancer between the ages of 18 and 99. To be eligible, individuals must meet the following requirements: Being at least eighteen years old when signing consent forms; Having an Eastern Cooperative Oncology Group performance status that does not exceed 2.; Being diagnosed with urothelial carcinoma of the bladder (mixed histologies are also applicable); Not having pure small cell carcinoma, adenocarcinoma or squamous cell carcinoma; Planning to have definitive surgery done (radical cystectomy)."
Does this medical investigation accept participants aged fifty or over?
"This medical experiment requires that potential participants are aged between 18 and 99. It should also be noted that there is a separate 38 studies devoted to testing on those under the age of majority, as well as 1339 different trials for elderly individuals over 65 years old."
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