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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
Subjects with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B has been given for > 8 weeks and viral load is < 100 IU/mL prior to first dose of trial treatment. Subjects with untreated hepatitis C virus (HCV) are allowed. Subjects with human immunodeficiency virus (HIV) who have CD4+ T-cell counts >= 350 cells/uL and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year are allowed
Pathologically confirmed locally advanced or metastatic urothelial carcinoma by histology
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 below
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My cancer is an advanced or spread bladder cancer confirmed by tests.
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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.
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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 am either not able to have children or I have a recent negative pregnancy test.
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I agree to use effective birth control and a barrier method during and 4 months after treatment.
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I may have had platinum-based chemo or bladder treatment before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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
87 Previous Clinical Trials
7,567 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,113 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04856189 — Phase 1 & 2
Bladder Cancer Research Study Groups: Treatment (selinexor, pembrolizumab)
Bladder Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04856189 — Phase 1 & 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04856189 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~0 spots leftby May 2024