ONCG100
Research type
Research Study
Full 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.
IRAS ID
264344
Contact name
Susan MacIntyre
Contact email
Sponsor organisation
Oncologie, Inc.
Eudract number
2019-000949-13
Duration of Study in the UK
1 years, 3 months, 2 days
Research summary
The purpose of this research study is to test the side effects of the study medication, bavituximab, when combined with a commercially available medication, Keytruda® (pembrolizumab) and to see if the cancer responds to this treatment by either preventing the disease from getting worse or shrinking the size of the tumors. Oncologie, Inc. is developing bavituximab as an immunomodulatory drug for the treatment of cancer. Bavituximab seems to work by modifying the immune system so that the cancer can be recognized by it and brought under control. Keytruda® (pembrolizumab) works in a similar but not identical manner as bavituximab. The two drugs together may result in greater control of the cancer.
Bavituximab is an attractive immunotherapeutic approach to treating cancer, because its primary mechanism of action involves altering the tumor microenvironment from a primarily immunosuppressive, angiogenesis-promoting (the development of new blood vessels) state to an immune activating state.
In essence, expression of phosphatidylserine on the external surface of the cell acts as an immunosuppressive signal in normal cell death and immune phagocytic clearance (process by which certain living cells called phagocytes ingest or engulf other cells or particles), thus allowing tumor growth and progression.
Exposing phosphatidylserine on the external surface of the cell provides a rich source of ligand for multiple immune receptors expressed on immune cells present in the microenvironment, including phosphatidylserine binding to T cell immunoglobulin and mucin domain 3 receptors.
Nonclinical data suggest that bavituximab and pembrolizumab can be co-administered effectively as demonstrated in murine models for melanoma and triple negative breast cancer. Combining phosphatidylserine-targeting antibody mch1N11 with a single dose of radiotherapy and anti-programmed cell death protein 1 (PD-1), a triple therapy combination, to treat mice bearing PD-1 resistant melanoma, results in almost complete tumor elimination and leads to statistically significant prolonged survival.
Research Summary:
CLINICAL TRIAL RESULTS SUMMARY A trial to find out how safe bavituximab plus pembrolizumab is in people with stomach cancer or cancer that starts where the food pipe joins the stomach and how well it works.
THANK YOU!
Thank you to those who participated in this research study for bavituximab plus pembrolizumab. Without trial participants, drug development would not be possible. Participation in this trial has helped the researchers learn how bavituximab plus pembrolizumab works, how safe the combination is to use, and has provided researchers with important information about stomach cancer or cancer that starts where the food pipe joins the stomach and possible treatment options.
The trial information given in this summary is from one trial only and must not be used to make medical decisions. Bavituximab is not yet approved and the outcomes of this trial may not apply to all patients. Do not change your current medical treatment without consulting your doctor.
WHAT IS BAVITUXIMAB PLUS PEMBROLIZUMAB?
Stomach (gastric) cancer or cancer that starts where the food pipe joins the stomach (gastroesophageal cancer) are types of cancer that affect the digestive system. Bavituximab is considered an experimental medicine that works by modifying the immune system so that it will recognize the cancer and bring it under control. Pembrolizumab is a commercially available medication that also works by modifying the immune system but not in an identical manner as bavituximab. Bavituximab plus pembrolizumab is a combination of the two medicines that is being tested for the treatment of stomach cancer or cancer that starts where the food pipe joins the stomach that may result in greater control of the cancer.
WHAT WAS THE PURPOSE OF THIS CLINICAL TRIAL?
This trial was designed to answer these questions:
Is bavituximab plus pembrolizumab safe and well tolerated by people with stomach cancer or cancer that starts where the food pipe joins the stomach?
How well does bavituximab plus pembrolizumab shrink tumours or reduce the extent of stomach cancer or cancer that starts where the food pipe joins the stomach?
HOW WAS THIS TRIAL DONE?
Who took part in this trial?
This trial included 60 men and 20 women between the ages of 21 and 82 years diagnosed with stomach cancer or cancer that starts where the food pipe joins the stomach, where the cancer had grown into the tissues around the stomach or into nearby organs, or had spread to distant parts of the body.
Two groups of people were studied in this trial:
• One group consisted of 45 men and 16 women whose cancer got worse after treatment with medicines that prevent the growth of cancer cells and who had not yet been treated with medicines that stimulate the body’s natural defences (immune system) to kill the cancer cells before the trial (Group 1)
• Another group consisted of 15 men and 4 women whose cancer stayed the same or improved and then got worse after being treated with medicines that stimulate the immune system to kill the cancer cells (Group 2).REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0597
Date of REC Opinion
21 Jan 2020
REC opinion
Further Information Favourable Opinion