An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
NCT ID: NCT04099641
Last Updated: 2023-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2019-09-11
2022-10-26
Brief Summary
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There is no expanded access program available for the investigational agents per this protocol.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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bavituximab and pembrolizumab
Bavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks
Bavituximab
Bavituximab IV infusion
Pembrolizumab Injection
Pembrolizumab IV Infusion
Interventions
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Bavituximab
Bavituximab IV infusion
Pembrolizumab Injection
Pembrolizumab IV Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men and women ≥ 18 years old; ≥ 20 years old in South Korea and Taiwan
* Unresectable metastatic or locally advanced gastric or GEJ adenocarcinoma
* Progressed on and/or after at least 1 prior regimen for metastatic disease or achieved stable disease or better in two consecutive scans to PD-1/PD-L1 inhibition alone or in combination with chemotherapy and relapsed
* Willing and able to provide fresh formalin-fixed paraffin-embedded tissue tumor sample
* Presence of at least one measurable lesion
* ECOG of 0 or 1
* Has adequate organ functions
* Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment.
* Women must not be breastfeeding.
* Women of childbearing potential , must agree to follow instructions for highly effective method(s) of contraception
* Males who are sexually active with women of childbearing potential must agree to follow instructions for highly effective method(s) of contraception
* Has adequate treatment washout period before start of study treatment
Exclusion Criteria
* Prior treatment with any checkpoint inhibitor or other therapies targeting T-cell control
* Known microsatellite instability-high (MSI-H) gastric or GEJ adenocarcinoma
* Medical history of myocardial infarction within 6 months before registration, symptomatic congestive heart failure (CHF) , troponin levels consistent with myocardial infarction, unstable angina, or serious cardiac arrhythmia
* Weight loss \>10% over 2 months prior to first dose of study treatment
* History of pneumonitis that required steroids or has current pneumonitis
* Has known active CNS metastases/and or carcinomatous meningitis
* Known additional malignancy that is progressing or has required active treatment in within the past 3 years
* An active infection requiring systemic therapy
* Known human immunodeficiency virus (HIV) infection or known acute hepatitis B or C infection
* Unresolved toxicities from previous cancer treatments
* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
* Active autoimmune disease or history of chronic recurrent autoimmune disease
* Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
* History of infusion reactions to any component/excipient of bavituximab
* History of severe hypersensitivity reactions to mAbs.
* Systemic steroid therapy within 7 days prior to the first dose of study treatment
* Has received a live vaccine within 30 days prior to first dose of study drug.
* Prior organ transplantation including allogeneic or autologous stem-cell transplantation
* Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
* Receipt of treatment with immunotherapy, biological therapies, or therapeutic doses of hormonal therapies within 3 weeks of scheduled C1D1 dosing
* Known psychiatric, substance abuse disorder, or geographical travel limitations that would interfere with participant's ability to cooperate with the requirements of the study
* Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
OncXerna Theraputics, Inc.
INDUSTRY
Responsible Party
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Locations
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Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
Cleveland Clinic Florida - Weston
Weston, Florida, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Siteman Cancer Center - Washington University Medical Campus
St Louis, Missouri, United States
White Plains Hospital - Center for Cancer Care
White Plains, New York, United States
UC Health Office of Clinical Research
Cincinnati, Ohio, United States
Cancer Treatment Centers of America at Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States
Sara Cannon Research Institute
Nashville, Tennessee, United States
Dong-A University Hospital
Busan, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou Branch
Taoyuan District, , Taiwan
The Royal Marsden
London, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-000949-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KEYNOTE PN978
Identifier Type: OTHER
Identifier Source: secondary_id
ONCG100
Identifier Type: -
Identifier Source: org_study_id
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