search
Back to results

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

Primary Purpose

Gastric Cancer, GastroEsophageal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bavituximab
Pembrolizumab Injection
Sponsored by
OncXerna Theraputics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Smilow Cancer Hospital at Yale-New Haven
  • Cleveland Clinic Florida - Weston
  • Columbus Regional Research Institute
  • The University of Chicago Medical Center
  • Siteman Cancer Center - Washington University Medical Campus
  • White Plains Hospital - Center for Cancer Care
  • UC Health Office of Clinical Research
  • Cancer Treatment Centers of America at Eastern Regional Medical Center
  • Sara Cannon Research Institute
  • Dong-A University Hospital
  • Kyungpook National University Chilgok Hospital
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Medical Foundation - Linkou Branch
  • The Royal Marsden
  • Sarah Cannon Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bavituximab and pembrolizumab

Arm Description

Bavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2019
Last Updated
January 13, 2023
Sponsor
OncXerna Theraputics, Inc.
Collaborators
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT04099641
Brief Title
An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
October 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OncXerna Theraputics, Inc.
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, GastroEsophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bavituximab and pembrolizumab
Arm Type
Experimental
Arm Description
Bavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Bavituximab
Intervention Description
Bavituximab IV infusion
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab Injection
Other Intervention Name(s)
Keytruda
Intervention Description
Pembrolizumab IV Infusion
Primary Outcome Measure Information:
Title
Number of Patients With Treatment Emergent Adverse Events (TEAE)
Description
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.
Time Frame
From first dose through 30 days after last dose. Maximum exposure: 567 days.
Title
Severity of Treatment Emergent Adverse Events (TEAE)
Description
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.
Time Frame
From first dose through 30 days after last dose. Maximum exposure: 567 days.
Title
Objective Response Rate (ORR)
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Smilow Cancer Hospital at Yale-New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Cleveland Clinic Florida - Weston
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Siteman Cancer Center - Washington University Medical Campus
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
White Plains Hospital - Center for Cancer Care
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Facility Name
UC Health Office of Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Cancer Treatment Centers of America at Eastern Regional Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Sara Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
702-210
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Linkou Branch
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
The Royal Marsden
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs