Unfavourable Opinion - A Phase I trial of AST-VAC2 vaccine in patients with NSCLC
Research type
Research Study
Full title
A Cancer Research UK Phase I trial of AST-VAC2 (allogeneic dendritic cell vaccine) administered weekly via intradermal injection in patients with non-small cell lung cancer in the advanced and adjuvant settings.
IRAS ID
218704
Contact name
Christian Ottensmeier
Contact email
Sponsor organisation
Cancer Research UK, Centre for Drug Development
Eudract number
2016-002577-35
Duration of Study in the UK
5 years, 0 months, 3 days
Research summary
Some cancers have more of a certain type of protein called hTERT and it has been shown that targeting hTERT can lead to destruction of cancer cells by the immune system. The study vaccine, AST-VAC2, will target the hTERT protein and help the immune system attack cancer cells. Human Leukocyte Antigen (HLA) is another type of protein. If a HLA test shows that a patient is positive for a specific HLA protein, this may mean that there is a better chance of the vaccine attacking the cancer (AST-VAC2 can only work with some types of HLA).
The study is a first in man clinical trial and is in two parts. Part 1 will ensure that the vaccine can be given safely and if there are any initial signs of how it works in the body. Part 2 will continue looking at the safety but also how the vaccine works in a group of patients without measurable cancer.
Approximately 24 patients with non-small cell lung cancer (NSCLC) will be treated with AST-VAC2. This includes 12 patients in Part 1 of the study (patients with advanced disease) and 12 patients in the Part 2 of the study (after surgical treatment). Alongside patients who receive the vaccine, the study will also ask approximately 24 patients, who will not be eligible to receive the vaccine because of their HLA test result, to be part of an observation group. This group of patients will continue to receive standard care. The study will then compare the vaccine treated group with the observation group.
The three main aims are to find out:
• If the dose can be given safely.
• Potential side effects and how they can be managed.
• What happens to AST-VAC2 inside the body (looking for effects in blood, skin or tumour).REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/0547
Date of REC Opinion
3 May 2017
REC opinion
Unfavourable Opinion