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Selinexor + Pembrolizumab for Bladder Cancer
Study Summary
This trial is testing the best dose of selinexor to give in combination with pembrolizumab to see how well it works in treating patients with urothelial carcinoma that cannot receive cisplatin or have disease that has gotten worse after treatment with cisplatin.
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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- I have previously been treated with selinexor or a similar drug.I do not have stomach or bowel problems that could affect medication absorption.I haven't had cancer treatment in the last 3 weeks.I am on high-dose steroids or other drugs to suppress my immune system for an autoimmune disease.I haven't taken high doses of steroids for 2 weeks before joining.I received radiation to my cancer less than 14 days before joining this study.My cancer is an advanced or spread bladder cancer confirmed by tests.I cannot or do not want to receive cisplatin-based chemotherapy due to kidney issues, severe nerve pain, hearing loss, or previous platinum-based treatment failure.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.My kidneys are working well enough, with a creatinine clearance of at least 30 mL/min.You must be able to swallow the study drug.I am either not able to have children or I have a recent negative pregnancy test.I agree to use effective birth control and a barrier method during and 4 months after treatment.I have previously been treated with immune therapy in a clinical trial.I may have had platinum-based chemo or bladder treatment before.
- Group 1: Treatment (selinexor, pembrolizumab)
- 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
How many participants have signed up for this research endeavor?
"Affirmative, clinicaltrials.gov data reveals that this medical study is still recruiting participants. This trial was first posted on the 8th April 2021 and edited on 28th June 2022- 12 patients are required to be enrolled from a single site."
Are there currently any opportunities to participate in this experiment?
"Affirmative. As per the latest information on clinicaltrials.gov, this medical trial is actively seeking volunteers to take part in their research. This program was first announced April 8th 2021 and has been recently updated on June 28 2022; they are currently seeking 12 subjects from a single site."
What pathologies are typically alleviated with Pembrolizumab?
"Pembrolizumab can be used as a therapeutic intervention for malignant neoplasms, unresectable melanoma, and cases of microsatellite instability high."
Has Pembrolizumab been used in previous research studies?
"At present, there are 1005 active trials for Pembrolizumab with 126 in their terminal phase. Although Houston, Texas has several clinical trial sites devoted to this drug, a total of 36620 locations around the world are conducting research with it."
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