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

OncXerna Theraputics

Status and phase

Completed

Phase 2

Conditions

Gastric Cancer

GastroEsophageal Cancer

Treatments

Drug: Pembrolizumab Injection

Drug: Bavituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04099641

2019-000949-13 (EudraCT Number)

KEYNOTE PN978 (Other Identifier)

ONCG100

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No 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