An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04099641
• Other study ID #: ONCG100
• Secondary ID: 2019-000949-13KE
• Status: Completed
• Phase: Phase 2
• Start date: September 11, 2019
• Est. completion date: October 26, 2022

Study information

• Verified date: December 2022
• Source: OncXerna Theraputics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. There is no expanded access program available for the investigational agents per this protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 26, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gastric Cancer
• GastroEsophageal Cancer
• Stomach Neoplasms

Intervention

Drug:
• Bavituximab
Bavituximab IV infusion
• Pembrolizumab Injection
Pembrolizumab IV Infusion

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation - Linkou Branch	Taoyuan
United Kingdom	Sarah Cannon Research Institute	London
United Kingdom	The Royal Marsden	London
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	UC Health Office of Clinical Research	Cincinnati	Ohio
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Sara Cannon Research Institute	Nashville	Tennessee
United States	Smilow Cancer Hospital at Yale-New Haven	New Haven	Connecticut
United States	Cancer Treatment Centers of America at Eastern Regional Medical Center	Philadelphia	Pennsylvania
United States	Siteman Cancer Center - Washington University Medical Campus	Saint Louis	Missouri
United States	Cleveland Clinic Florida - Weston	Weston	Florida
United States	White Plains Hospital - Center for Cancer Care	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
OncXerna Theraputics, Inc.	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first dose through 30 days after last dose. Maximum exposure: 567 days.
Primary	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.	From first dose through 30 days after last dose. Maximum exposure: 567 days.
Primary	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.	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.