Exploratory Phase II
EudraCT No. 2011-003958-85
In June 2012, a Phase II, single-arm, UK-based investigative study was initiated which examined IMM‑101 in combination with a single targeted dose of radiation in patients with metastatic colorectal cancer for whom chemotherapy or other treatment had not been effective (IMM‑101‑007). An optimised Simon 2-stage design was used and 12 patients were recruited into the first part of the study.
Progression to the second part of the study, in which a further 19 patients were to be recruited, required an objective response or stabilisation of disease at 24 weeks in accordance with immune-related response criteria in at least one of the first 12 patients. No such response was observed; the results were analysed and reported in accordance with the protocol and the primary conclusion was that no synergy was demonstrated between immunomodulation with IMM‑101 and cyber-knife treatment in the 12 chemotherapy-experienced, advanced metastatic colorectal cancer patients studied.