Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma
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ClinicalTrials.gov Identifier: NCT02364076 |
Recruitment Status : Unknown
Verified November 2018 by Georgetown University.
Recruitment status was: Active, not recruiting
First Posted : February 16, 2015
Results First Posted : December 13, 2019
Last Update Posted : December 13, 2019
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Sponsor:
Georgetown University
Collaborators:
Merck Sharp & Dohme LLC
Incyte Corporation
Information provided by (Responsible Party):
Georgetown University
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Tracking Information | |||||
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First Submitted Date ICMJE | February 10, 2015 | ||||
First Posted Date ICMJE | February 16, 2015 | ||||
Results First Submitted Date ICMJE | August 6, 2019 | ||||
Results First Posted Date ICMJE | December 13, 2019 | ||||
Last Update Posted Date | December 13, 2019 | ||||
Actual Study Start Date ICMJE | March 2015 | ||||
Actual Primary Completion Date | June 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Response Rate [ Time Frame: 24 months ] To measure response of all the participants to the drug at the end of the study.
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Original Primary Outcome Measures ICMJE |
Response rate [ Time Frame: 24 months ] complete response plus partial response as determined by RECIST 1.1
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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 and Epacadostat in Patients With Thymic Carcinoma | ||||
Official Title ICMJE | Pembrolizumab (MK-3475) and Epacadostat (INCB024360) in Thymic Carcinomas | ||||
Brief Summary | This is a non-randomized clinical trial in patients with thymic carcinomas who failed prior systemic therapy. All subjects will receive pembrolizumab and epacadostat treatment in three week cycles until unacceptable toxicity, death, progressive disease or withdrawal. | ||||
Detailed Description | The amended phase II study of pembrolizumab and epacadostat is for thymic carcinoma patients who recurred after at least one prior chemotherapy regimen. The primary endpoint is response rate; secondary endpoints are Progression-Free Survival, Overall Survival and treatment tolerability. Responses will be assessed according to RECIST 1.1; progression-free survival is defined as time between start of treatment and tumor progression or death; survival is the time between start of treatment and death. Furthermore exploratory studies will be performed on archival tumor material (PDL-1 expression, next-generation sequencing), and fresh biopsies (culturing; next-generation sequencing). | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
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: Pembrolizumab and Epacadostat
Pembrolizumab 200 mg intravenously every 3 weeks Epacadostat 100mg by mouth taken daily
Interventions:
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Publications * |
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* 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 | Unknown status | ||||
Actual Enrollment ICMJE |
45 | ||||
Original Estimated Enrollment ICMJE |
17 | ||||
Estimated Study Completion Date ICMJE | December 2021 | ||||
Actual Primary Completion Date | June 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | NCT02364076 | ||||
Other Study ID Numbers ICMJE | 2014-1315 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Georgetown University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Georgetown University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Georgetown University | ||||
Verification Date | November 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |