A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT03946800 |
Recruitment Status :
Completed
First Posted : May 13, 2019
Last Update Posted : October 31, 2023
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Tracking Information | |||||||||||
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First Submitted Date ICMJE | May 6, 2019 | ||||||||||
First Posted Date ICMJE | May 13, 2019 | ||||||||||
Last Update Posted Date | October 31, 2023 | ||||||||||
Actual Study Start Date ICMJE | May 8, 2019 | ||||||||||
Actual Primary Completion Date | August 24, 2023 (Final data collection date for primary outcome measure) | ||||||||||
Current Primary Outcome Measures ICMJE |
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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 | A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors | ||||||||||
Official Title ICMJE | A Phase 1, Open-label, Dose-escalation and Expansion Study of MEDI1191 Administered Intratumorally as Monotherapy and in Combination With Durvalumab in Subjects With Advanced Solid Tumors | ||||||||||
Brief Summary | To evaluate MEDI1191 administered intratumorally in sequential and concurrent combination with intravenous durvalumab in patients with solid tumors. | ||||||||||
Detailed Description | This is a multicenter, open-label study to evaluate MEDI1191 delivered by intratumoral injection in sequential and concurrent combination with intravenous durvalumab to subjects with solid tumors. The study has a dose escalation design using mTPI-2 to evaluate a range of doses. | ||||||||||
Study Type ICMJE | Interventional | ||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel 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 |
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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 |
61 | ||||||||||
Original Estimated Enrollment ICMJE |
87 | ||||||||||
Actual Study Completion Date ICMJE | August 24, 2023 | ||||||||||
Actual Primary Completion Date | August 24, 2023 (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 to 101 Years (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 | Spain, United States | ||||||||||
Removed Location Countries | France, Netherlands | ||||||||||
Administrative Information | |||||||||||
NCT Number ICMJE | NCT03946800 | ||||||||||
Other Study ID Numbers ICMJE | D8510C00001 2020-005784-31 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | MedImmune LLC | ||||||||||
Original Responsible Party | Same as current | ||||||||||
Current Study Sponsor ICMJE | MedImmune LLC | ||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||
Collaborators ICMJE | Not Provided | ||||||||||
Investigators ICMJE |
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PRS Account | MedImmune LLC | ||||||||||
Verification Date | October 2023 | ||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |