A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients
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ClinicalTrials.gov Identifier: NCT01308762 |
Recruitment Status
:
Completed
First Posted
: March 4, 2011
Results First Posted
: December 6, 2012
Last Update Posted
: December 6, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | 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 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Official Title: | 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 |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: IMM-101
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
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:
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:
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:
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- Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 56 days ]
Safety and tolerability were measured with respect to:
- Safety measurements
- Local tolerability at the site of intradermal injection
- Incidence of adverse events.
- Administration Site Reactions [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308762
United Kingdom | |
HCA Clinical Trials Unit, 79 Harley Street, | |
London, United Kingdom, W1G 8PZ |
Principal Investigator: | Justin Stebbings, Professor | Imperial College Healthcare NHS Trust |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Immodulon Therapeutics Ltd |
ClinicalTrials.gov Identifier: | NCT01308762 History of Changes |
Other Study ID Numbers: |
IMM-101-001 2009-012447-42 ( EudraCT Number ) |
First Posted: | March 4, 2011 Key Record Dates |
Results First Posted: | December 6, 2012 |
Last Update Posted: | December 6, 2012 |
Last Verified: | September 2012 |
Additional relevant MeSH terms:
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |