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Radiation Therapy

Neutron Radiation + Pembrolizumab for Bladder Cancer

Phase 2

Waitlist Available

Led By Jing Zeng

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligible for checkpoint inhibitor immunotherapy (pembrolizumab) per standard of care

Zubrod performance status 0-2

Must not have

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Summary

This trial is studying how well neutron radiation therapy and pembrolizumab work to treat urothelial carcinoma that has spread to other parts of the body.

Who is the study for?

This trial is for adults with advanced urothelial carcinoma, a type of bladder cancer. Participants must have normal organ function, no history of certain autoimmune diseases or active infections, and not be on steroids. They should have at least two measurable tumors and be eligible for immunotherapy with pembrolizumab as well as neutron radiation therapy.Check my eligibility

What is being tested?

The study is testing the combination of neutron radiation therapy (a type of high-energy radiation to shrink tumors) and pembrolizumab (an immunotherapy drug that helps the immune system fight cancer). The goal is to see if this combo is more effective than radiation alone in treating advanced bladder cancer.See study design

What are the potential side effects?

Possible side effects include fatigue, skin reactions from radiation, flu-like symptoms, nausea, changes in blood counts leading to increased risk of infection or bleeding. Pembrolizumab can also cause an overactive immune response which might affect organs like lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for immunotherapy with pembrolizumab.

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I can take care of myself and am up more than 50% of my waking hours.

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I have never needed treatment for an autoimmune disease.

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My kidney function, measured by creatinine, is within the normal range.

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My blood clotting time is normal or managed with medication.

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My blood clotting time is normal or managed if I'm on blood thinners.

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My cancer is confirmed to be urothelial carcinoma.

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I can have neutron radiation for up to 3 cancer spread sites.

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I haven't taken steroids for 2 weeks and don't expect to need them during the study.

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I have at least two tumors that can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have been diagnosed with HIV.

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I have or had lung inflammation not caused by an infection.

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I have an active tuberculosis infection.

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I am currently being treated for an infection.

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I have another cancer that is getting worse or needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Overall response rate per immune-modified response evaluation criteria in solid tumors

Secondary outcome measures

Overall survival

Progression-free survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Pembrolizumab, neutron radiation therapy)Experimental Treatment3 Interventions

Participants receive pembrolizumab IV on days 1 and 22. On day 23, participants may undergo an optional tumor biopsy and receive 3-5 treatments of neutron radiation therapy over 2 weeks on days 23-42. Participants receive pembrolizumab IV on day 43 and continue per standard of care in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,762 Previous Clinical Trials

1,876,469 Total Patients Enrolled

Jing ZengPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

7 Previous Clinical Trials

97 Total Patients Enrolled

Media Library

Neutron Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03486197 — Phase 2

Bladder Cancer Research Study Groups: Treatment (Pembrolizumab, neutron radiation therapy)

Bladder Cancer Clinical Trial 2023: Neutron Radiation Therapy Highlights & Side Effects. Trial Name: NCT03486197 — Phase 2

Neutron Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03486197 — Phase 2

~2 spots leftby Jul 2025

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