Abemaciclib + Pembrolizumab In Glioblastoma
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ClinicalTrials.gov Identifier: NCT04118036 |
Recruitment Status :
Withdrawn
(Safety concerns)
First Posted : October 7, 2019
Last Update Posted : December 14, 2021
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | October 4, 2019 | ||||||||||||||
First Posted Date ICMJE | October 7, 2019 | ||||||||||||||
Last Update Posted Date | December 14, 2021 | ||||||||||||||
Estimated Study Start Date ICMJE | December 1, 2021 | ||||||||||||||
Estimated Primary Completion Date | December 1, 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 | Not Provided | ||||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Abemaciclib + Pembrolizumab In Glioblastoma | ||||||||||||||
Official Title ICMJE | A Phase 2 Study of Abemaciclib and Pembrolizumab in Recurrent Glioblastoma | ||||||||||||||
Brief Summary | This research study is studying a combination therapy as a possible treatment for recurrent glioblastoma (GBM), a brain tumor that is growing or progressing despite earlier treatment. This study will involve participants with recurrent glioblastoma at their first relapse enrolled in two arms including patients who require reoperation and patients not requiring surgery. This research study involves a combination of two drugs:
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Detailed Description | This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. Many brain cancers show over expression of a protein called cyclin D1. That means that the body makes too much cyclin D1, which affects enzymes called CDK 4 and CDK 6. Enzymes are substances in the body that help reactions between cells happen. Too much cyclin D1 triggers CDK 4 and CDK 6 to make more cells than normal. This extra cell production leads to the growth of tumors. In laboratory studies, abemaciclib was able to enter the brain, stop CDK 4 and CDK 6 from making cells, and slow growth of glioblastoma in mice. Pembrolizumab (MK-3475) has been studied in lab experiments and in other types of cancer. Information from these studies suggests that Pembrolizumab (MK-3475) may be beneficial inrecurrent glioblastoma (GBM). Pembrolizumab (MK-3475) is a humanized monoclonal antibody. An antibody is a common type of protein made in the body in response to a foreign substance. Antibodies attack foreign substances and protect against infection. Antibodies can also be produced in the laboratory for use in treating patients; an antibody that is made in the lab is also known as a humanized monoclonal antibody that is designed to block the action of the receptor, PD-1. PD-1 works to help tumor cells continue to grow and multiply. There are now several approved antibodies for the therapy of cancer and other diseases. . |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Glioblastoma | ||||||||||||||
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 | Withdrawn | ||||||||||||||
Actual Enrollment ICMJE |
0 | ||||||||||||||
Original Estimated Enrollment ICMJE |
47 | ||||||||||||||
Estimated Study Completion Date ICMJE | December 1, 2024 | ||||||||||||||
Estimated Primary Completion Date | December 1, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
The following archived tissue is required for Cohort 2 patients: --- 20 unstained formalin fixed paraffin embedded (FFPE) sections (standard 5 micrometer thickness). The following amount of archived tissue is required for Cohort 1 patients:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Months and older (Child, 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 | NCT04118036 | ||||||||||||||
Other Study ID Numbers ICMJE | 19-351 | ||||||||||||||
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 | Patrick Y. Wen, MD, Dana-Farber Cancer Institute | ||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | December 2021 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |