Squamous cell carcinoma of the anus (SCCA) is a rare cancer, however its incidence is
increasing worldwide. SCCA is mostly induced by human papillomavirus (HPV) infections
(high-risk types such as HPV-16 and -18) and HPV-related oncoproteins (E6 and E7) are
expressed in more than 90% of cases. T stage and N stage are recognized prognostic factors
for local and/or distant recurrence in SCCA patients treated by CRT. In fact, ≥T3 or ≥N1 anal
cancers are associated with as high as 50% disease recurrence rate at 2 years.
Since 1996 when concomitant radiotherapy and MMC (mytomicin C) and 5-FU-based chemotherapy
demonstrated superiority to radiotherapy alone, no significant progress has been achieved in
patients with locally advanced SCCA. Still, phase III study by James et al. reported in 2013
showed that prognosis of SCCA patients treated with this regimen can be improved probably due
to a better tumor classification, more precise radiological methods, known as "Will Rogers
Based on the above, investigators have designed this phase II trial assessing the feasibility
and efficacy of Ezabenlimab (BI 754091) and mDCF chemotherapy combination followed by:
standard chemoradiotherapy in case of low response to induction treatment (<30% by
RECIST criteria) or
additional 2 cycles of mDCF and 1 cycle of Ezabenlimab (BI 754091) followed by
hypofractionated radiotherapy in case of high response (≥ 30% by RECIST criteria)
in SCCA patients with high-risk locally advanced (stage III) disease.
In summary, the first innovative aspect of this research program is to provide a valuable
proof of concept study evaluating the feasibility to combine radiotherapy, chemotherapies
(docetaxel, cisplatin and 5-fluorouracil) and Ezabenlimab (BI 754091) in patients with stage
III squamous cell anal carcinoma. INTERACT-ION study will provide evidence that Ezabenlimab
(BI 754091) acts in synergy with mDCF to improve complete response rate, and both with
hypofractionated radiotherapy to improve the disease-free survival enhancing TH1 and CD8 T
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.