A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients

To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed Mycobacterium obuense) in 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.

• Biological: Heat killed whole cell M. obuense (IMM-101) 0.1 mg

  Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.

  Dose levels to be administered are 0.1 mg, 0.5 mg and 1.0 mg.

  Other Names:

  • IMM-101
  • Mycobaterium obuense
• Biological: Heat-killed whole cell M.obuense (IMM-101) 0.5 mg
  Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.
  Other Names:

  • IMM-101
  • Mycobaterium obuense
• Biological: Heat killed whole cell M.obuense (IMM-101) 1.0 mg
  Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.
  Other Names:

  • IMM-101
  • Mycobaterium obuense

Inclusion Criteria:

• confirmed diagnosis of disease free stage III or stage IV melanoma (with or without metastases) or stable disease (if with metastases) and receiving no other treatment
• willing to use effective contraception for the duration of the study
• able to comply with the requirement to complete a diary card

Exclusion Criteria:

• Pregnant or lactating females
• Major surgery within the 14 days preceding the screening visit
• Suspicion of a previous infection with mycobacteria including previous tuberculosis (TB) prophylaxis
• Treatment with another investigational medicinal product within the last 30 days prior to the screening visit
• Previous treatment with M. vaccae
• Exposure to Bacille Calmette Guérin vaccine (BCG) within the last 12 months
• Concurrent uses of drugs likely to reduce inflammation at the local injection site or dampen/modulate the immune system
• Depot injection of corticosteroids within 6 weeks of the screening visit or chronic systemic corticosteroids in the 2 weeks prior to the screening visit
• Ongoing treatment with radiotherapy, cytotoxic chemotherapy or chemotherapy in the last 30 days prior to the screening visit

• HCA International Limited
• Theradex