Clinical trial NCT04099641: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
GastroEsophageal Cancer
Lead sponsor: OncXerna Theraputics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-09-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Patients With Treatment Emergent Adverse Events (TEAE)
timeFrame: From first dose through 30 days after last dose. Maximum exposure: 567 days.
measure: Severity of Treatment Emergent Adverse Events (TEAE)
timeFrame: From first dose through 30 days after last dose. Maximum exposure: 567 days.
measure: Objective Response Rate (ORR)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale-New Haven
state: Connecticut
city: Weston
country: United States
facility: Cleveland Clinic Florida - Weston
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Saint Louis
country: United States
facility: Siteman Cancer Center - Washington University Medical Campus
state: Missouri
city: White Plains
country: United States
facility: White Plains Hospital - Center for Cancer Care
state: New York
city: Cincinnati
country: United States
facility: UC Health Office of Clinical Research
state: Ohio
city: Philadelphia
country: United States
facility: Cancer Treatment Centers of America at Eastern Regional Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sara Cannon Research Institute
state: Tennessee
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou Branch
city: London
country: United Kingdom
facility: The Royal Marsden
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
Study officials:
References: