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

Phase 1

Completed

Interventions: Biological: Heat killed whole cell M. obuense (IMM-101) 0.1 mg
Biological: Heat-killed whole cell M.obuense (IMM-101) 0.5 mg
Biological: Heat killed whole cell M.obuense (IMM-101) 1.0 mg

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
IMM-101	Heat killed whole cell M. obuense (IMM-101) 0.1 mg	Patients received 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. Doses used were: 'Heat killed whole cell M. obuense (IMM-101) 0.1 mg', 'Heat killed whole cell M. obuense (IMM-101) 0.5 mg', or 'Heat killed whole cell M. obuense (IMM-101) 1.0 mg'
IMM-101	Heat-killed whole cell M.obuense (IMM-101) 0.5 mg	Patients received 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. Doses used were: 'Heat killed whole cell M. obuense (IMM-101) 0.1 mg', 'Heat killed whole cell M. obuense (IMM-101) 0.5 mg', or 'Heat killed whole cell M. obuense (IMM-101) 1.0 mg'
IMM-101	Heat killed whole cell M.obuense (IMM-101) 1.0 mg	Patients received 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. Doses used were: 'Heat killed whole cell M. obuense (IMM-101) 0.1 mg', 'Heat killed whole cell M. obuense (IMM-101) 0.5 mg', or 'Heat killed whole cell M. obuense (IMM-101) 1.0 mg'

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	56 days	Safety and tolerability were measured with respect to: 1. Safety measurements 2. Local tolerability at the site of intradermal injection 3. Incidence of adverse events.

Secondary Outcome Measures

Name	Time	Method
Administration Site Reactions	Day -3 to Day 56	Local skin reactions are viewed as a normal and predicted reaction to exposure to a preparation of mycobacterial antigens. All patients experienced administration site reactions and all reactions were examined and characterised. However only those reported as adverse events are presented here.