A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Heat killed whole cell M. obuense (IMM-101) 0.1 mg; Heat-killed whole cell M.obuense (IMM-101) 0.5 mg; Heat killed whole cell M.obuense (IMM-101) 1.0 mg
Intervention description: 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.; 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.; 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.
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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