An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04099641 |
Recruitment Status :
Active, not recruiting
First Posted : September 23, 2019
Last Update Posted : June 15, 2022
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Sponsor:
OncXerna Theraputics, Inc.
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
OncXerna Theraputics, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | September 18, 2019 | ||||
First Posted Date ICMJE | September 23, 2019 | ||||
Last Update Posted Date | June 15, 2022 | ||||
Actual Study Start Date ICMJE | September 11, 2019 | ||||
Actual Primary Completion Date | December 20, 2021 (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 | An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients | ||||
Official Title ICMJE | A Phase 2, Multicenter Open-label, Non-randomized Study of Bavituximab Plus Pembrolizumab in Patients With Advanced Gastric or Gastroesophageal Cancer Who Have Progressed on or After at Least One Prior Standard Therapy | ||||
Brief Summary | This study evaluates the combination of bavituximab and pembrolizumab in the treatment of gastric and gastroesphogeal cancer. All patients will receive both bavituximab, a drug that is not yet approved by the FDA, and pembrolizumab known as Keytruda. There is no expanded access program available for the investigational agents per this protocol. |
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Detailed Description | Not Provided | ||||
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: bavituximab and pembrolizumab
Bavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks
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 | Active, not recruiting | ||||
Actual Enrollment ICMJE |
80 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2022 | ||||
Actual Primary Completion Date | December 20, 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 | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Korea, Republic of, Taiwan, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04099641 | ||||
Other Study ID Numbers ICMJE | ONCG100 2019-000949-13 ( EudraCT Number ) KEYNOTE PN978 ( Other Identifier: Merck ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | OncXerna Theraputics, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | OncXerna Theraputics, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Merck Sharp & Dohme LLC | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | OncXerna Theraputics, Inc. | ||||
Verification Date | June 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |