CORINTH
Research type
Research Study
Full title
Phase 1b/II Trial of Checkpoint Inhibitor (Pembrolizumab an Anti PD-1 Antibody) Plus Standard IMRT in HPV Induced Stage III Squamous Cell Carcinoma of Anus
IRAS ID
228287
Contact name
Marcia Hall
Contact email
Sponsor organisation
Cardiff University
Eudract number
2017-002300-27
Duration of Study in the UK
3 years, 10 months, 1 days
Research summary
This trial is for patients with advanced anal cancer. The aim of the trial is to see whether a new drug called pembrolizumab can be added safely to chemo-radiotherapy (CRT). We will explore how safe the combination is and how well tolerated it is for patients. Anal cancer responds well to CRT and this would be the treatment usually chosen for clinical care. The chemotherapy given will be the standard of care (Mitomycin and either 5FU or capecitabine) and radiotherapy will be delivered using a technique where the dose can be modulated for different areas of the tumour. Tissue and blood samples will be collected before, during and after treatment.
Pembrolizumab has been shown to be safe and effective when given alone and with chemotherapy in the treatment of other types of cancer but has not yet been used much in anal cancer. It is a monoclonal antibody that enhances the body’s immune response to cancer cells by acting on a receptor on a special T-cell surface receptor (called Programmed Death-1).
The initial trial is designed in 3 groups of 6 patients. All patients will receive eight infusions of pembrolizumab at three weekly intervals. The first group will not get pembrolizumab until they have already had 4 weeks of CRT. As long as this is not found to cause too many extra side effects, the next group will have infusions at the beginning of the third week of CRT. The final group will start their pembrolizumab with the first day of chemo-radiotherapy.
Additional patients will be recruited into the group with the greatest exposure to pembrolizumab with radiation and least side effects (ie. hopefully starting the pembrolizumab on the first day of the chemoradiation) to form an expansion cohort for assessment of less common side effects and possible effectiveness.REC name
London - Brent Research Ethics Committee
REC reference
19/LO/0314
Date of REC Opinion
25 Jun 2019
REC opinion
Further Information Favourable Opinion