Pembrolizumab With Locally Delivered Radiation Therapy for the Treatment of Metastatic Esophageal Cancers
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ClinicalTrials.gov Identifier: NCT02642809 |
Recruitment Status :
Completed
First Posted : December 30, 2015
Last Update Posted : November 24, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | December 24, 2015 | ||||
First Posted Date ICMJE | December 30, 2015 | ||||
Last Update Posted Date | November 24, 2021 | ||||
Actual Study Start Date ICMJE | June 8, 2016 | ||||
Actual Primary Completion Date | September 24, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Tolerability of localized esophageal hypofractionated brachytherapy administered in two fractions when combined with pembrolizumab as measured by treatment related adverse events [ Time Frame: 30 days after completion of treatment (estimated to be 7 months) ] -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Pembrolizumab With Locally Delivered Radiation Therapy for the Treatment of Metastatic Esophageal Cancers | ||||
Official Title ICMJE | A Pilot Study Combining Pembrolizumab With Locally Delivered Radiation Therapy for the Treatment of Metastatic Esophageal Cancers | ||||
Brief Summary | The investigators propose to treat patients with metastatic esophageal cancers and dysphagia with two fractions of brachytherapy followed by pembrolizumab. The brachytherapy is hypofractionated and will provide a radiation dose of sufficient intensity to induce the release of tumor-derived antigens and trigger an antitumor immune response. The simplicity of the design should maximize the chance to examine the hypothesis that radiotherapy can induce an immune response, which can then be augmented by pembrolizumab treatment. Success in this study would provide the impetus to conduct further trials aimed at developing this unique strategy as a more broadly applicable therapeutic option in the treatment of patients suffering from these deadly cancers, and will provide important mechanistic insights into the relationship between radiation treatment and immune therapy augmentation. Taken together, these data indicate that targeting the PD-1/PD-L1 axis in esophageal cancers in combination with radiation therapy may be a rational treatment strategy for these cancers. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Arm 1: Pembrolizumab and Brachytherapy
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
16 | ||||
Original Estimated Enrollment ICMJE |
15 | ||||
Actual Study Completion Date ICMJE | August 3, 2021 | ||||
Actual Primary Completion Date | September 24, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Has received systemic therapy within 4 weeks of the first dose of pembrolizumab.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02642809 | ||||
Other Study ID Numbers ICMJE | 201603087 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Washington University School of Medicine | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Washington University School of Medicine | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Merck Sharp & Dohme LLC | ||||
Investigators ICMJE |
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PRS Account | Washington University School of Medicine | ||||
Verification Date | November 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |