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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04099641
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : January 28, 2020
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Oncologie Inc.

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE September 23, 2019
Last Update Posted Date January 28, 2020
Actual Study Start Date  ICMJE September 11, 2019
Estimated Primary Completion Date January 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Incidence and severity of Treatment Emergent Adverse Events(TEAE) [ Time Frame: From first dose through 30 days after last dose ]
    Incidence by 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
  • Objective Response Rate [ Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months ]
    Objective response rate (ORR) as assessed by the Investigator per RECIST version1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Cancer
  • GastroEsophageal Cancer
Intervention  ICMJE
  • Drug: Bavituximab
    Bavituximab IV infusion
  • Drug: Pembrolizumab Injection
    Pembrolizumab IV Infusion
    Other Name: Keytruda
Study Arms  ICMJE Experimental: bavituximab and pembrolizumab
Bavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks
  • Drug: Bavituximab
  • Drug: Pembrolizumab Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2021
Estimated Primary Completion Date January 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Oncologie Inc. 1-781-907-7810
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04099641
Other Study ID Numbers  ICMJE ONCG100
2019-000949-13 ( EudraCT Number )
KEYNOTE PN978 ( Other Identifier: Merck )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oncologie Inc.
Study Sponsor  ICMJE Oncologie Inc.
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE Not Provided
PRS Account Oncologie Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP