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.

OncXerna Therapeutics, Inc.0 sites80 target enrollmentJuly 30, 2019

Overview

No summary available.

Registry

who.int

Start Date

July 30, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•For Group 1 only (CPI naïve):
•1\. Progressed on and/or after at least 1 prior regimen for metastatic disease which includes a fluoropyrimidine and a platinum:
•Progression within 6 months of prior adjuvant or neoadjuvant chemotherapy will be deemed a rapid progressor and thus, equivalent to 1 advanced/metastatic disease treatment regimen.
•Changing from IV to oral fluoropyrimidine without noted progression is considered only 1 prior regimen.
•Human epidermal growth factor receptor 2 (HER2\)\-positive patients must have received prior anti\-HER2 therapy and demonstrate PD or was ineligible for such therapy.
•For Group 2 only (CPI relapse):
•2\. Patient achieved stable disease or better in two
•consecutive scansachieved stable disease or better in two consecutive scans to PD\-1/PD\-L1 inhibition alone or in combination with chemotherapy and relapsed following PD\-1/PD\-L1 inhibition either alone or in combination with chemotherapy
•All patients must be immediate (defined by within 3 months) progressors of PD 1/PD\-L1 inhbition with no intervening treatment with other agents such as chemotherapy alone.
•For both Group 1 and Group 2:

•For Group 1 only (CPI naïve):
•1\. Prior treatment with any checkpoint inhibitor or other therapies targeting T\-cell control.
•For Group 2 only (CPI relapse):
•2\. Primary refractory patients, defined as disease progression at first scan following initiation of PD\-1/PD\-L1 inhibitor treatment, or if best overall response to PD 1/PD L1 inhibition was disease progression
•For both Group 1 and Group 2:
•3\. Received any form of anti\-phosphatidylserine therapies.
•4\. Known microsatellite instability\-high (MSI\-H) gastric or GEJ adenocarcinoma
•5\. Medical history of myocardial infarction within 6 months before registration, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV;), troponin levels consistent with myocardial infarction as defined according to American College of Cardiologists (ACC) guidelines, unstable angina, or serious cardiac arrhythmia requiring treatment.
•6\. Experienced weight loss \>10% over 2 months prior to first dose of study treatment.
•7\. History of (non\-infectious) pneumonitis that required steroids or has current pneumonitis.