An Intra-patient Placebo-controlled, Phase I Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 (Heat-killed Mycobacterium Obuense) in Adult Melanoma Cancer Patients
The proposed study is a first-in-man, placebo-controlled, dose escalation trial to evaluate
the safety and tolerability of three different doses of IMM-101 administered intradermally
to melanoma patients. Additionally, the study aims to characterize local responses to this
vaccine in order to delineate unexpected / unacceptable local reactions from those
indicative of appropriate immunological response in this patient group.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Safety and tolerability were measured with respect to: Safety measurements Local tolerability at the site of intradermal injection Incidence of adverse events.
Justin Stebbings, Professor
Imperial College Healthcare NHS Trust
United Kingdom: Medicines and Healthcare Products Regulatory Agency