Neutron Radiation Therapy and Pembrolizumab in Treating Participants With Advanced Urothelial Carcinoma
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|ClinicalTrials.gov Identifier: NCT03486197|
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma||Other: Laboratory Biomarker Analysis Biological: Pembrolizumab Radiation: Radiation Therapy||Phase 2|
I. To assess the overall response rate to neutron radiation (with high relative biological effectiveness relative to standard photon radiation) to a metastatic focus in combination with standard of care checkpoint inhibitor immunotherapy (pembrolizumab), in patients with advanced urothelial carcinoma.
I. Progression free survival.
II. Overall survival.
III. Safety and tolerability as evaluated by the incidence, severity, duration, causality, seriousness, and type(s) of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Participants receive pembrolizumab intravenously (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.
After completion of study treatment, participants are followed up every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Neutron Radiotherapy With Concurrent Checkpoint Inhibitor Immunotherapy (Pembrolizumab) in Patients With Advanced Urothelial Carcinoma|
|Actual Study Start Date :||January 17, 2019|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||November 1, 2022|
Experimental: Treatment (Pembrolizumab, neutron radiation therapy)
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.
Other: Laboratory Biomarker Analysis
Radiation: Radiation Therapy
Undergo neutron radiation therapy
- Overall response rate per immune-modified response evaluation criteria in solid tumors [ Time Frame: Up to 3 years ]Overall response rate will be calculated as the percentage of patients achieving a partial response or complete response, and will be presented along with the 95% confidence interval (CI).
- Overall survival [ Time Frame: Up to 3 years ]This will be estimated with the Kaplan and Meier method with 95% CI obtained using Greenwood estimates of variance.
- Progression-free survival [ Time Frame: Up to 3 years ]This will be estimated with the Kaplan and Meier method with 95% CI obtained using Greenwood estimates of variance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486197
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Jing Zeng 206-598-8822 email@example.com|
|Principal Investigator: Jing Zeng|
|Principal Investigator:||Jing Zeng||Fred Hutch/University of Washington Cancer Consortium|