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
Gary Middleton
Contact email
Eudract number
2016-002577-35
Duration of Study in the UK
5 years, 0 months, 2 days
Research summary
Summary of Research
The study vaccine, AST-VAC2, will target the hTERT protein and help the immune system attack cancer cells. The vaccine is made by taking human embryonic stem cells and developing in the laboratory to become dendritic cells. Dendritic cells occur naturally in the body as part of the immune system and have a special role in finding proteins in the body which are associated with cancer. It is hoped that the vaccine will train the immune system to recognise these proteins and attack the cancer.Some cancers have more of a type of protein called hTERT. It has been shown that targeting hTERT can lead to cancer cell destruction by the immune system. Human Leukocyte Antigen (HLA) is another type of protein. If 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 in two parts. Part 1 (safety cohort) will ensure that the vaccine can be given safely and if there are initial signs of how it works in the body. Patients in Part 1 have advanced disease who have no other suitable treatment options. Part 2 (expansion cohort) will continue looking at safety but also how the vaccine works in a group of patients with a different disease stage (without measurable cancer), who have completed all suitable treatment options (chemotherapy +/- surgery) and have no other treatment planned.
Approximately 24 patients with non-small cell lung cancer will be treated with AST-VAC2. This includes 12 patients in Part 1 and 12 patients in Part 2 of the study. 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 the HLA result, to be part of a control group. This group of patients will continue to receive standard care. The study will then compare the vaccine group with the control 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).Summary of Results
The trial design was amended during the trial to only include Part 1 (for patients with advanced NCSLC). Part 2 (for patients with a different disease stage) and the control groups were removed.A summary of results is available at https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-a-vaccine-called-ast-vac2-for-non-small-cell-lung-cancer
REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/1397
Date of REC Opinion
21 Sep 2017
REC opinion
Further Information Favourable Opinion