Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer
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ClinicalTrials.gov Identifier: NCT03557918 |
Recruitment Status :
Recruiting
First Posted : June 15, 2018
Last Update Posted : December 17, 2020
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Tracking Information | |||||||||
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First Submitted Date ICMJE | June 5, 2018 | ||||||||
First Posted Date ICMJE | June 15, 2018 | ||||||||
Last Update Posted Date | December 17, 2020 | ||||||||
Actual Study Start Date ICMJE | November 12, 2018 | ||||||||
Estimated Primary Completion Date | March 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Objective Response Rate [ Time Frame: 24 months ] Estimate the objective response rate (RECIST 1.1) with tremelimumab in subjects with metastatic urothelial cancer previously treated with PD-1/PD-L1 blockade. The objective response rate is the proportion of all subjects with confirmed PR or CR according to RECIST, from the start of treatment until disease progression/recurrence
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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 | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer | ||||||||
Official Title ICMJE | Phase 2 Trial of Tremelimumab in Patients With Metastatic Urothelial Cancer Previously Treated With PD-1/PD-L1 Blockade | ||||||||
Brief Summary | This is a phase II trial designed to estimate the activity of single agent tremelimumab in subjects with metastatic urothelial cancer with disease progression despite prior treatment with PD-1/PD-L1 blockade. The primary endpoint is objective response rate and the study will employ a Simon's 2-stage design. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single group assignment Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Urothelial Carcinoma | ||||||||
Intervention ICMJE | Drug: Tremelimumab
Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria. |
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Study Arms ICMJE | Experimental: Tremelimumab
Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles.
Intervention: Drug: Tremelimumab
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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 | Recruiting | ||||||||
Estimated Enrollment ICMJE |
28 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 2021 | ||||||||
Estimated Primary Completion Date | March 2021 (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 |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03557918 | ||||||||
Other Study ID Numbers ICMJE | HCRN GU17-294 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Matthew Galsky, Hoosier Cancer Research Network | ||||||||
Study Sponsor ICMJE | Matthew Galsky | ||||||||
Collaborators ICMJE | AstraZeneca | ||||||||
Investigators ICMJE |
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PRS Account | Hoosier Cancer Research Network | ||||||||
Verification Date | December 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |