Phase 1b/II Trial of Pembrolizumab Plus IMRT in Stage III/IV Carcinoma of Anus

To be considered for this study, you need to be at least 18 years old and have been diagnosed with a specific type of advanced anal cancer (called Squamous Cell Cancer of Anus, Stage 3 or 4). Your doctors usually confirm this diagnosis, and you'd be recommended for standard chemotherapy and radiotherapy treatment.

You would also need to be generally well enough to undergo the treatment, as judged by your doctor. This means your body, including your blood count, kidney function, and liver function, should be working adequately. Female participants who could become pregnant would also need to take a pregnancy test and agree to use effective contraception throughout the study.

Basically, the study is for adults with advanced anal cancer who are healthy enough for intensive treatment and are willing to provide tissue samples for further research.

If you join this study, you will receive Pembrolizumab through a drip into your arm every three weeks, for a total of eight doses, with each session lasting about an hour. You will also have your standard chemotherapy and radiotherapy, which is specifically designed to target the tumour. The timing of your first Pembrolizumab dose will depend on which study group you are in; it could be after several weeks of your standard treatment, or you might start it earlier, even on the very first day. Throughout the treatment, the study team will closely monitor you for any side effects, particularly during your weekly visits and at every Pembrolizumab session. You'll also be asked to complete questionnaires about how you are feeling, which helps researchers understand your experience. After your treatment finishes, you will continue to have follow-up appointments for 12 months to monitor your health and the treatment's effect.