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

Sponsor
OncXerna Theraputics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04099641
Collaborator
Merck Sharp & Dohme LLC (Industry)
80
Enrollment
21
Locations
1
Arm
39.7
Anticipated Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
N/A
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 :
Sep 11, 2019
Actual Primary Completion Date :
Dec 20, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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 Names:
  • Keytruda

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and severity of Treatment Emergent Adverse Events(TEAE) [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Smilow Cancer Hospital at Yale-New Haven New Haven Connecticut United States 06511
    2 Cleveland Clinic Florida - Weston Weston Florida United States 33331
    3 Columbus Regional Research Institute Columbus Georgia United States 31904
    4 The University of Chicago Medical Center Chicago Illinois United States 60637
    5 Siteman Cancer Center - Washington University Medical Campus Saint Louis Missouri United States 63110
    6 White Plains Hospital - Center for Cancer Care White Plains New York United States 10601
    7 UC Health Office of Clinical Research Cincinnati Ohio United States 45229
    8 Cancer Treatment Centers of America at Eastern Regional Medical Center Philadelphia Pennsylvania United States 19124
    9 Sara Cannon Research Institute Nashville Tennessee United States 37203
    10 Dong-A University Hospital Busan Korea, Republic of 49201
    11 Kyungpook National University Chilgok Hospital Daegu Korea, Republic of 702-210
    12 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13620
    13 Asan Medical Center Seoul Korea, Republic of 05505
    14 Samsung Medical Center Seoul Korea, Republic of 06351
    15 Seoul National University Hospital Seoul Korea, Republic of 110-744
    16 China Medical University Hospital Taichung Taiwan 40447
    17 National Cheng Kung University Hospital Tainan Taiwan 704
    18 Taipei Veterans General Hospital Taipei Taiwan 11217
    19 Chang Gung Medical Foundation - Linkou Branch Taoyuan Taiwan 33305
    20 The Royal Marsden London United Kingdom SW3 6JJ
    21 Sarah Cannon Research Institute London United Kingdom W1G 6AD

    Sponsors and Collaborators

    • OncXerna Theraputics, Inc.
    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    OncXerna Theraputics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04099641
    Other Study ID Numbers:
    • ONCG100
    • 2019-000949-13
    • KEYNOTE PN978
    First Posted:
    Sep 23, 2019
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Pembrolizumab
    Bavituximab

    Study Results

    No Results Posted as of Jun 15, 2022