AST-VAC2 Vaccine in Patients With Non-small Cell Lung Cancer

General Information

Summary This clinical study is looking at a vaccine called AST-VAC2 in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings. The main aim of the study: If the dose can be given safely to patients, learn more about the potential side effects of the vaccine and how they can be managed and also what happens to AST-VAC2 inside the body (looking for effects in the blood, skin or tumour).
Description This clinical study is looking at a vaccine called AST-VAC2. AST-VAC2 has been designed to potentially help the immune system attack the cancer. This is a new vaccine which looks promising in laboratory studies but it has never been tested in man. Dendritic cells occur naturally in your body as part of the immune system however these dendritic cells have a special role in finding proteins in the body which are associated with cancer and it is hoped that the vaccine will train the immune system to recognise these proteins and attack the cancer. Some cancers tend to have more of a certain type of protein (part of the body's building blocks that make up cells) called 'hTERT' and it has been shown in laboratory studies (and also studies in patients using a similar type of vaccine), that targeting hTERT can lead to destruction of cancer cells by the immune system. AST-VAC2 will target the hTERT protein. Human Leukocyte Antigen (HLA) is another type of protein. An HLA pre-screening test will be able to show if a person is positive or negative for a specific HLA protein (AST-VAC2 can only work with some types of HLA), as being positive for the protein may mean there is a better chance of the vaccine attacking the cancer. Patients who are positive for the specific HLA type will be asked to consent to the vaccine arm i.e. to receive the study vaccine. Those patients who are negative for the HLA type will be asked to consent to a control arm and will not receive the study vaccine. The study is in two parts, Part 1 (safety cohort) is to ensure that the vaccine can be given safely and to see if there are any initial signs of how it works in the body by performing tests on blood and tissue samples. Patients with advanced NSCLC will be asked to participate in Part 1. Part 2 (expansion cohort) is to continue looking at the safety of the vaccine but also how the vaccine works in a group of patients at a different stage of disease. Patients in the adjuvant setting will be asked to participate in Part 2. Control groups will be recruited for both Parts 1 and 2 of the study.
Clinical trials phase Phase 1
Start date (estimated) 2018-06-01
End date (estimated) 2022-10-16
Clinical feature
Label Non-small cell lung carcinoma
Link http://purl.obolibrary.org/obo/HP_0030358

Administrative Information

NCT Number NCT03371485
Other study identifiers
Name CRUKD/17/003
Source weblink https://clinicaltrials.gov/ct2/show/NCT03371485
Regulatory body approval
Country
Public contact
Email Louisa.Essame@cancer.org.uk
First name Louisa
Last name Essame
Country
United Kingdom
Sponsors Cancer Research UK

Cell Line

Stem cell lines obtained from

Recruitment

Recruitment Status Recruiting
Estimated number of participants 48