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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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.

Timeline

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

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,925 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

Frequently Asked Questions

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

Could you please provide me with an overview of the previous experiments conducted on Pembrolizumab?

"Currently, 961 clinical studies involving Pembrolizumab are active. Of those live trials, 122 have reached Phase 3 of testing. Houston is the epicentre for the majority of these tests; however there are 35,727 international sites offering this treatment protocol."

Answered by AI

What is the scope of participation in this clinical experiment?

"Affirmative. Clinicaltrials.gov's data reveals that this study, launched on January 17th 2019, is actively looking for participants. Specifically, 20 patients must be recruited from a singular clinical site."

Answered by AI

To what maladies is Pembrolizumab most commonly administered?

"Pembrolizumab has been used to treat malignant neoplasms, unresectable melanomas, and cases of microsatellite instability high."

Answered by AI

Does the FDA accept Pembrolizumab as a therapeutic measure?

"After careful assessment, the safety of pembrolizumab was judged to be a 2 out of 3. This is because this phase 2 trial has evidence in favor of its safety but no proof that it's effective yet."

Answered by AI

Is enrollment still open for this medical trial?

"According to clinicaltrials.gov, this research venture is currently seeking trial participants. The initial listing was published on the 17th of January 2019 and recently amended on the 21st of June 2022."

Answered by AI
~2 spots leftby Apr 2025