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Trial record 1 of 1 for:    04099641
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An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients

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ClinicalTrials.gov Identifier: NCT04099641
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Oncologie 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.


Condition or disease Intervention/treatment Phase
Gastric Cancer GastroEsophageal Cancer Drug: Bavituximab Drug: Pembrolizumab Injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 11, 2019
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: bavituximab and pembrolizumab
Bavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks
Drug: Bavituximab
Bavituximab IV infusion

Drug: Pembrolizumab Injection
Pembrolizumab IV Infusion
Other Name: Keytruda




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099641


Contacts
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Contact: Oncologie Inc. 1-781-907-7810 medical@oncologie.international

Locations
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United States, Georgia
Columbus Regional Research Institute Recruiting
Columbus, Georgia, United States, 31904
United States, Tennessee
Sara Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Oncologie Inc.
Merck Sharp & Dohme Corp.

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Responsible Party: Oncologie Inc.
ClinicalTrials.gov Identifier: NCT04099641     History of Changes
Other Study ID Numbers: ONCG100
2019-000949-13 ( EudraCT Number )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pembrolizumab
Bavituximab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs