An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
- Conditions
- Gastric CancerGastroEsophageal Cancer
- Interventions
- Registration Number
- NCT04099641
- Lead Sponsor
- OncXerna Theraputics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Signed written informed consent
- 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
- Received any form of anti-phosphatidylserine therapies
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description bavituximab and pembrolizumab Bavituximab Bavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks bavituximab and pembrolizumab Pembrolizumab Injection Bavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks
- Primary Outcome Measures
Name Time Method Number of Patients With Treatment Emergent Adverse Events (TEAE) From first dose through 30 days after last dose. Maximum exposure: 567 days. Incidence of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose.
Severity of Treatment Emergent Adverse Events (TEAE) From first dose through 30 days after last dose. Maximum exposure: 567 days. Severity of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose.
Objective Response Rate (ORR) From date of first dose until the date of CR, PR, first documented progression or date of death from any cause, whichever came first. Maximum exposure: 567 days. ORR was based on RECIST version 1.1 criteria for target lesions, where a patient may achieve as best overall response (BOR) either complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline summary of diameters. ORR is calculated as the number of patients achieving a CR or PR (objective response) divided by the number of efficacy patients.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
UC Health Office of Clinical Research
🇺🇸Cincinnati, Ohio, United States
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Sara Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Smilow Cancer Hospital at Yale-New Haven
🇺🇸New Haven, Connecticut, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Chang Gung Medical Foundation - Linkou Branch
🇨🇳Taoyuan, Taiwan
Cancer Treatment Centers of America at Eastern Regional Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
White Plains Hospital - Center for Cancer Care
🇺🇸White Plains, New York, United States
The Royal Marsden
🇬🇧London, United Kingdom
Sarah Cannon Research Institute
🇬🇧London, United Kingdom
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Cleveland Clinic Florida - Weston
🇺🇸Weston, Florida, United States
Siteman Cancer Center - Washington University Medical Campus
🇺🇸Saint Louis, Missouri, United States
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of