Gastric CancerPhase 2NCT04099641
An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
A Phase 2 study testing Bavituximab and Pembrolizumab Injection in people with Gastric Cancer and GastroEsophageal Cancer, run by OncXerna Theraputics, Inc. at 21 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, GastroEsophageal Cancer
- What is being tested?
- Bavituximab and Pembrolizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 11 Sep 2019to 26 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
United States9 sites
The University of Chicago Medical Center
Chicago, Illinois, 60637
UC Health Office of Clinical Research
Cincinnati, Ohio, 45229
Columbus Regional Research Institute
Columbus, Georgia, 31904
Sara Cannon Research Institute
Nashville, Tennessee, 37203
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06511
Cancer Treatment Centers of America at Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
Siteman Cancer Center - Washington University Medical Campus
St Louis, Missouri, 63110
Cleveland Clinic Florida - Weston
Weston, Florida, 33331
White Plains Hospital - Center for Cancer Care
White Plains, New York, 10601
South Korea6 sites
Dong-A University Hospital
Busan, 49201
Kyungpook National University Chilgok Hospital
Daegu, 702-210
Seoul National University Bundang Hospital
Seongnam-si, 13620
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Seoul National University Hospital
Seoul, 110-744
Taiwan4 sites
China Medical University Hospital
Taichung, 40447
National Cheng Kung University Hospital
Tainan, 704
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Medical Foundation - Linkou Branch
Taoyuan, 33305
United Kingdom2 sites
The Royal Marsden
London, SW3 6JJ
Sarah Cannon Research Institute
London, W1G 6AD
About this study
Official title: 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
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.
- Conditions
- Gastric Cancer, GastroEsophageal Cancer
- Being tested
- Bavituximab, Pembrolizumab Injection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BavituximabDrug
Bavituximab IV infusion
Pembrolizumab InjectionDrug
Also called Keytruda
Pembrolizumab IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| bavituximab and pembrolizumab | Experimental | Bavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks Receives: Drug: Bavituximab; Drug: Pembrolizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Treatment Emergent Adverse Events (TEAE)
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.
Measured: From first dose through 30 days after last dose. Maximum exposure: 567 days.
Severity of Treatment Emergent Adverse Events (TEAE)
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.
Measured: From first dose through 30 days after last dose. Maximum exposure: 567 days.
Objective Response Rate (ORR)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start11 Sep 2019
- Primary completion20 Dec 2021
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncXerna Theraputics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099641
- Sponsor's protocol ID
- ONCG100
- Other IDs
- 2019-000949-13, KEYNOTE PN978, 2019
- Status last verified
- Dec 2022
- First submitted
- 18 Sep 2019
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ntellas P, Park H, Culm K, Lee J, Youssoufian H, Mockbee C, Uhlik M, Benjamin L, Chau I. Targeting Phosphatidylserine in Advanced Gastric and Gastroesophageal Junction Adenocarcinomas: A Phase 2 Trial of Bavituximab Plus Pembrolizumab with Biomarker-Correlated Outcomes. Curr Oncol. 2026 May 28;33(6):319. doi: 10.3390/curroncol33060319.
PubMed 42346219
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04099641
- Acronym / sponsor ID
- ONCG100
- Conditions
- Gastric Cancer, GastroEsophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- OncXerna Theraputics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bavituximab and pembrolizumab | Experimental | Drug: Bavituximab, Drug: Pembrolizumab InjectionBavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BavituximabBavituximab IV infusion | Drug | bavituximab and pembrolizumab |
| Pembrolizumab InjectionAlso: KeytrudaPembrolizumab IV Infusion | Drug | bavituximab and pembrolizumab |
Primary outcome
Number of Patients With Treatment Emergent Adverse Events (TEAE)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42346219Ntellas P, Park H, Culm K, Lee J, Youssoufian H, Mockbee C, Uhlik M, Benjamin L, Chau I. Targeting Phosphatidylserine in Advanced Gastric and Gastroesophageal Junction Adenocarcinomas: A Phase 2 Trial of Bavituximab Plus Pembrolizumab with Biomarker-Correlated Outcomes. Curr Oncol. 2026 May 28;33(6):319. doi: 10.3390/curroncol33060319.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bavituximab and Pembrolizumab Injection in people with Gastric Cancer and GastroEsophageal Cancer, run by OncXerna Theraputics, Inc. at 21 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, South Korea, Taiwan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Treatment Emergent Adverse Events (TEAE) (time frame: From first dose through 30 days after last dose. Maximum exposure: 567 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04099641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.