Researchers in the U.K. are beginning a Phase 1 clinical trial testing the efficacy and safety of a possibly groundbreaking therapy — a vaccine to enable the immune system to fight advanced cancer, defined in the study as solid tumors of any type, in people no longer responding to standard cancer therapy.
The VAPER trial, for “In Vivo Generation of Optimal Tumour Antigen-specific Anticancer Immune Responses, by Vaccination with Human Telomerase Reverse Transcriptase (hTERT) Peptides, in Combination with Specific Adjuvants and Elimination of Immunosuppressive Regulatory Cells, in Patients with Advanced Cancer,” is being conducted at the National Institute for Health Research (NIHR) Guy’s and St Thomas’ Clinical Research Facility, and the NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London. It is currently recruiting patients, with a total of 10 participants expected, and other U.K. research sites are expected to open later this year.
The vaccine, made of small molecules called hTERT peptides, works by mimicking natural immune responses generated to fight viral and bacterial infections. It will be administered once every three weeks, along with low-dose cyclophosphamide (chemotherapy) tablets, according to the trial’s site on Cancer Research UK. Some participants will be randomized to also receive celecoxib, a non-steroidal anti-inflammatory drug. The vaccine will be evaluated for its potential benefits and to assess side effects.
“We know that the immune system in patients with advanced cancer is suppressed, so it’s unable to recognise and kill cancer calls. In this trial we are investigating a form of immunotherapy designed to activate the body’s immune system by administration of a vaccine based on fragments of a key cancer protein,” Professor Hardev Pandha, director of the Surrey Cancer Research Institute (SCRI) and one of the trial’s principal investigators, said in a press release.
The first two patients have already been vaccinated, and VAPER is expected to run for 18 to 24 months. It calls for two parts, with the second part only being initiated if at least one patient shows a positive response to the vaccine.
“The unique feature of this study is the use of additional agents to boost the vaccination response. It is hoped this will abolish the inhibitory effect of regulatory immune cells present in the patients’ circulation, which are believed to have limited the effectiveness of previous cancer vaccine approaches,” said Dr. James Spicer, principal investigator at the BRC and King’s College London.
The VAPER trial protocol was developed based on pilot immunotherapy data and is supported by results from related studies conducted in Europe, the U.K. and the U.S.
“This trial is pushing new boundaries for potential cancer treatments, and brings new hope for patients in the fight against cancer,” said George Freeman, government minister for Life Sciences. “The prospect of a vaccine to help the body’s immune system fight advanced cancer highlights the ground-breaking work being delivered by our world-leading life sciences sector, supported through the Government’s continued investment in the National Institute for Health Research.”
Kelly Potter, a 35-year-old Beckenham resident with stage 4 cervical cancer, has already received a first vaccine treatment. Her experience to date has been positive, she said.
“[W]hen I was told that I may be eligible for this trial, I was delighted. When I read the leaflet about the VAPER trial it struck me that it seemed a bit of breakthrough and that if it worked, it could be a revolution in the treatment of cancer. To be part of the trial has changed my life for the better. It’s been a very positive experience and really interesting. I feel honoured to be involved. … I had my first injection on Tuesday 9th February and have another seven visits to complete the treatment. They did say there may be flu like symptoms but I haven’t noticed anything yet. The way I have been cared for and treated by the clinical trial staff is exceptional,” Potter said. “My hope for the future is to beat the cancer for as long as I can.”
More information on this trial, including enrollment information, is available through this link.