VISTA
Research type
Research Study
Full title
A phase I/IIa, double-blinded, randomised controlled trial to assess the safety, tolerability, and early signs of anti-tumour activity of ITOP1 – a prime/boost viral vector vaccine targeting tumour specific antigens in subjects with surgically resectable oesophageal adenocarcinoma
IRAS ID
1008088
Contact name
Mark Middleton
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN12981444
Research summary
Unfortunately, it is very common for patients with oesophageal cancer for cancer to return at a later date. The VISTA trial aims at reducing this risk for those patients with oesophageal cancer who have received an initial course of chemotherapy and then had their main tumour removed by surgery. VISTA will investigate a new cancer vaccine called ITOP1, which uses technology based on viruses. A cancer vaccine is similar to those given for seasonal flu, and is made up of dead/weakened germs to train the immune system to protect against future infection. ITOP1 aims to help the immune system ‘mop up’ any cancer cells still in the body after treatment and prevent them from developing into new cancers.
ITOP1 has not been used on patients before, and VISTA is designed to look at its safety, any side effects the vaccine may cause, as well as early signs of the vaccine’s potential to prevent cancer coming back. Current UK standard of care for newly diagnosed treatment of oesophageal cancer is based on a course of chemotherapy given before the primary tumour is removed by surgery, followed by further chemotherapy once the patient has fully recovered from surgery. The first (prime) injection of the ITOP1 dose will be given 4 weeks after the first course of chemotherapy and before the surgery. A second (boost) dose injection would be given before the second course of chemotherapy. This ensures that it would not harm the standard of care that the patients can expect to receive. The aim of ITOP1 is that once the main tumour is removed, the body's immune response will be triggered by the vaccine and prevent the cancer from returning or spreading, which is the cause for the majority of oesophageal cancer deaths. In Phase I of the trial, 8x participants will receive ITOP1 and then a review of these patients' side effects to ITOP1 will be carried out before Phase II opens. Phase II will recruit 52x participants, to receive either ITOP1 or saline, which will be randomly assigned.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0004
Date of REC Opinion
12 Feb 2025
REC opinion
Further Information Favourable Opinion