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PD-1 Inhibitor
Selinexor + Pembrolizumab for Bladder Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Mamta Parikh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed locally advanced or metastatic urothelial carcinoma by histology
>= 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with advanced or metastatic urothelial carcinoma who can't take cisplatin due to health issues like kidney dysfunction, nerve damage, hearing loss, or have already tried it without success. They should be relatively healthy otherwise and willing to use effective birth control if they can have children.Check my eligibility
What is being tested?
The trial is testing the combination of Selinexor, which blocks a protein needed by cancer cells to grow, and Pembrolizumab, an immunotherapy that helps the immune system fight cancer. It aims to find the best dose of Selinexor and see how well it works with Pembrolizumab in patients who are ineligible for cisplatin or whose cancer has worsened after using it.See study design
What are the potential side effects?
Selinexor may cause fatigue, nausea, weight loss, low blood counts leading to increased infection risk or bleeding problems. Pembrolizumab might lead to immune-related side effects such as inflammation in various organs including lungs and intestines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is an advanced or spread bladder cancer confirmed by tests.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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My kidneys are working well enough, with a creatinine clearance of at least 30 mL/min.
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I agree to use effective birth control and a barrier method during and 4 months after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) (Phase II)
Recommended phase 2 dose (RP2D) (Phase Ib)
Secondary outcome measures
Incidence of grade 3 or higher AEs
Progression-free survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (selinexor, pembrolizumab)Experimental Treatment2 Interventions
Patients receive selinexor PO on days 1, 8 and 15, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Selinexor
2020
Completed Phase 2
~1360
Find a Location
Who is running the clinical trial?
Mamta ParikhLead Sponsor
6 Previous Clinical Trials
198 Total Patients Enrolled
Karyopharm Therapeutics IncIndustry Sponsor
88 Previous Clinical Trials
7,627 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,719 Previous Clinical Trials
40,963,521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (selinexor, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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