An intra-patient placebo-controlled, Phase I clinical study, to evaluate the safety and tolerability of intra‑dermal IMM‑101 (Heat‑killed Mycobacterium obuense) in adult melanoma cancer patients
EudraCT No. 2009-012447-42
IMM‑101 was evaluated in an open-label, dose-escalation, placebo-controlled Phase I study (IMM‑101‑001), in 18 adult patients with confirmed diagnosis of stage III or IV melanoma (i.e. late-stage skin cancer where the disease has spread beyond the site of the tumour and surgical treatment alone is insufficient). The study evaluated the safety and tolerability of three intradermal doses of IMM‑101 (0.1 mg, 0.5 mg and 1.0 mg), with a six-patient cohort for each dose, which was administered on three separate occasions with a 14-day interval between each.
On completion of the 0.1mg dose cohort, there was a safety review before the first 0.5mg dose was given to the next cohort of six patients, with a similar process for escalation to the 1mg dose. No dose-limiting toxicities or significant treatment-related adverse events were seen in this four-week study, and injection-site reactions were consistent with this class of product and well tolerated by the patients. Although not a formal study of clinical responses, it was notable that as a group, the 13 patients with stage IV disease, especially those previously extensively treated, survived longer than might otherwise have been expected. These initial Phase II data have been published (Stebbing et al, 2012).