Corinth

CORINTH is a trial for patients with advanced (stage 3 and 4) anal cancer.

The CORINTH trial will evaluate the addition of a new drug called pembrolizumab to the current chemoradiation treatment that would be usually chosen as standard clinical care. We want to find out how well pembrolizumab is tolerated when given with standard chemoradiation and to make sure that there aren’t any unexpected interactions between pembrolizumab and the chemoradiation. To date, 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 very much in anal cancer.

The trial is designed in 3 groups of patients. All patients will receive eight infusions of pembrolizumab at three weekly intervals. The first group of 6 patients will not get pembrolizumab until they have already had 4 weeks of chemoradiation. As long as this is not found to cause too many extra side effects, the next group of 6 patients will have infusions at the beginning of the third week of chemoradiation. The third group will start their pembrolizumab with the first day of chemoradiation.

Provided each group of patients finds the treatment tolerable and it is safe, 32 more patients will be recruited into the group that receives the pembrolizumab earliest during Chemotherapy and Radiation Therapy (CRT). This will add further credibility to the safety and tolerability of the combination and may provide a signal of how effective this treatment might be in improving outcomes for patients with more advanced anal cancer.

The results of this trial will be used to design further Phase II/III trials (with larger number of study participants) to establish the anti-tumour effect of pembrolizumab and chemoradiation in anal cancer.

Technical details: CORINTH is a phase Ib/II trial of checkpoint inhibitor (pembrolizumab an anti PD-1 antibody) plus standard IMRT in HPV induced stage III/IV carcinoma of anus.