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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Melanoma

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMM-101<br>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' | Biological: Heat killed whole cell M. obuense (IMM-101) 0.1 mg<br>* 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.<br>* Other names: Mycobaterium obuense;Biological: Heat-killed whole cell M.obuense (IMM-101) 0.5 mg<br>* 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.<br>* Other names: Mycobaterium obuense;Biological: Heat killed whole cell M.obuense (IMM-101) 1.0 mg<br>* 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.<br>* Other names: Mycobaterium obuense;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Administration Site Reactions | 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. | Day -3 to Day 56 |