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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012447-42 | EudraCT Number |
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| Name | Class |
|---|---|
| HCA International Limited | OTHER |
| Theradex | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMM-101 | Experimental | 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' |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat killed whole cell M. obuense (IMM-101) 0.1 mg | Biological | 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. |
| 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:
| 56 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Stebbings, Professor | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCA Clinical Trials Unit, 79 Harley Street, | London | W1G 8PZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21930686 | Derived | Stebbing J, Dalgleish A, Gifford-Moore A, Martin A, Gleeson C, Wilson G, Brunet LR, Grange J, Mudan S. An intra-patient placebo-controlled phase I trial to evaluate the safety and tolerability of intradermal IMM-101 in melanoma. Ann Oncol. 2012 May;23(5):1314-1319. doi: 10.1093/annonc/mdr363. Epub 2011 Sep 19. |
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Five patients were found to be ineligible and failed screening. These patients were withdrawn before receiving study medication.
A total of 24 patients with melanoma entered the screening phase of this study between 10 March 2010 and 27 July 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | IMM-101 0.1 mg | Patients received an intradermal injection of IMM-101 0.1 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28. |
| FG001 | IMM-101 0.5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Heat-killed whole cell M.obuense (IMM-101) 0.5 mg | Biological | 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. |
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| Heat killed whole cell M.obuense (IMM-101) 1.0 mg | Biological | 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. |
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Patients received an intradermal injection of IMM-101 0.5 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
| FG002 | IMM-101 1.0 mg | Patients received an intradermal injection of IMM-101 1.0 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | IMM-101 0.1 mg |
| BG001 | Group 2 | IMM-101 0.5 mg |
| BG002 | Group 3 | IMM-101 1.0 mg |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Safety and tolerability were measured with respect to:
| All analyses were based on the safety population, which comprised of all patients who received at least one dose of IMP. Safety measurements and nature and incidence of adverse events were reported for the Safety population | Posted | Number | Participants | 56 days |
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| Secondary | 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. | Safety population | Posted | Number | Participants | Day -3 to Day 56 |
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Adverse event data were collected on the followings days: -3, 0, 3, 14, 17, 28, 31, 42, 56
In accordance with the EU Clinical Trials Directive the investigator reported any directly observed AEs and any AEs reported spontaneously by the patient. In addition, each patient was questioned about AEs at each visit before administration of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | IMM-101 0.1 mg | 0 | 6 | 5 | 6 | ||
| EG001 | Group 2 | IMM-101 0.5 mg | 1 | 7 | 7 | 7 | ||
| EG002 | Group 3 | IMM-101 1.0 mg | 0 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patient experienced progressive shortness of breath and was hospitalised for supportive care whilst undergoing investigations. The cause was collapse of the left lower lobe of the lung with a metastatic mass - consistent with progressive disease. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered ECG | Cardiac disorders | Systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chest Infection | Infections and infestations | Systematic Assessment |
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| Common cold | Infections and infestations | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Enlarged Lymph node | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Eye proptosis | Eye disorders | Systematic Assessment |
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| Flu-like symptoms | General disorders | Systematic Assessment |
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| Generalised or joint ache /pain | General disorders | Systematic Assessment |
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| Hard red swelling on cheek | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Herpes | Infections and infestations | Systematic Assessment |
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| Hypotension | General disorders | Systematic Assessment |
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| Increased LDH | Investigations | Systematic Assessment |
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| Injection site reaction | General disorders | Systematic Assessment |
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| Mild ear pain | Ear and labyrinth disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| New Lump | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| New lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Red eye | Eye disorders | Systematic Assessment |
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| Redness on face | General disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Skin erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sore throat | Gastrointestinal disorders | Systematic Assessment |
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| Temperature | General disorders | Systematic Assessment |
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| Tiredness | General disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Warts | Infections and infestations | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Co-ordinator | Immodulon Therapeutics, The London Clinic Cancer Centre, London W1G 6JA, | +44 (0)203 219 3568/3572 | Ilda@immodulon.com |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C574749 | IMM-101 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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