Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT01559818
Status:
TERMINATED
Last Update Posted:
2023-06-22
First Post:
2012-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Long Term Follow up Study for Patients Who Previously Took Part in the Phase I Study IMM-101-001
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574749', 'term': 'IMM-101'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@immodulon.com', 'phone': '+44 (0)20 3137 6346', 'title': 'Chief Medical Officer', 'organization': 'Immodulon Therapeutics Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The median survival time was not calculable as less than 50% patients died. No inferences can be made from the rate of survival due to the small sample size.\n\nGiven the fact patients could receive anti-cancer therapy on study, disease status fluctuated throughout the study (better, worse, no change). This coupled with the sparsity of CT or MRI scan data collected on a per patient basis resulted in only Best Overall Response being described.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)', 'description': 'Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal.\n\nAdverse event information could be obtained during study visits or by telephone contact with the patient between visits.', 'eventGroups': [{'id': 'EG000', 'title': 'IMM-101', 'description': 'IMM-101 1.0 mg I.D.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 4, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events With a Causal Relationship to IMM-101', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMM-101', 'description': 'IMM-101 1.0 mg I.D.\n\nIMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).', 'description': 'Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities. Treatment related Adverse Events were defined as being definitely, probably or possibly related to IMM-101 or with an unknown relationship.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population = all enrolled patients'}, {'type': 'PRIMARY', 'title': 'Treatment Emergent Adverse Events of NCI CTCAE ≥Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMM-101', 'description': 'IMM-101 1.0 mg I.D.\n\nIMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).', 'description': 'Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population = all enrolled patients'}, {'type': 'PRIMARY', 'title': 'Treatment Emergent Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMM-101', 'description': 'IMM-101 1.0 mg I.D.\n\nIMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).', 'description': 'Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities.\n\nThere were no IMM-101 related serious adverse events reported during the study.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population = all enrolled patients'}, {'type': 'SECONDARY', 'title': 'Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMM-101', 'description': 'IMM-101 1.0 mg administered intradermally'}], 'classes': [{'categories': [{'title': 'Died', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Censored', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Alive', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Overall survival was defined as the time from enrolment until date of death for up to 81 months. Patients still alive after 81 months were censored at withdrawal from the study or at last known date alive if later.', 'description': 'Overall survival', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There was only one analysis population in the study. Safety, tolerability and efficacy endpoints were summarised using the safety population, defined as all patients who received at least one dose of the study treatment'}, {'type': 'SECONDARY', 'title': 'Incidence of Change in Metastatic Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMM-101', 'description': 'IMM-101 1.0 mg I.D.\n\nIMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.'}], 'classes': [{'title': 'Best Overall Response = Not known', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Best overall response = Improved', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Best Overall Response = No Change / Stable Disease', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Best Overall Response = Disease worsening', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Informed Consent to death or withdrawal (median 4.4 years, range 1.2 - 6.7)', 'description': 'The protocol required any change in metastatic disease to be documented where possible. However, given this was a real-life long-term follow-up study, CT or MRI scans were not mandated as part of the protocol and were only performed as clinically indicated. Very few scans were performed during the course of the study (0 to nine events per patient). Given the fact patients could receive anti-cancer therapy on study, disease status fluctuated throughout the study (better, worse, no change). This coupled with the sparsity of CT or MRI scan data collected on a per patient basis resulted in only Best Overall Response being described.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Translational Research', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMM-101', 'description': 'IMM-101 1.0 mg administered intradermally'}], 'timeFrame': 'From baseline to death or withdrawal', 'description': 'Blood samples were collected and sera prepared for analysis of immunological markers and mediators.\n\nExploratory endpoints may include a change in one or more markers of immune status based on cellular involvement, function or cytokine/immune mediator production such as, for example, cytokines and antibodies, or any other clinically or immunologically relevant assays.', 'reportingStatus': 'POSTED', 'populationDescription': 'Extensive translational research on serum samples from other studies with IMM-101 failed to identify any clinically significant impact on relevant immunological markers or mediators. Therefore no analysis was perform on the samples from this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IMM-101', 'description': 'IMM-101 1.0 mg administered intradermally\n\nIMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'IMM-101', 'description': 'IMM-101 1.0 mg I.D.\n\nIMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'This study and the preceding IMM-101-001 study were conducted in the United Kingdom only', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled patients'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-05', 'size': 1330122, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-06T08:53', 'hasProtocol': True}, {'date': '2019-04-10', 'size': 2036265, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-06T08:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Sponsor considered no further meaningful data was being collected, nor were likely to be collected in the future.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2012-03-19', 'resultsFirstSubmitDate': '2021-08-06', 'studyFirstSubmitQcDate': '2012-03-20', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-22', 'studyFirstPostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Translational Research', 'timeFrame': 'From baseline to death or withdrawal', 'description': 'Blood samples were collected and sera prepared for analysis of immunological markers and mediators.\n\nExploratory endpoints may include a change in one or more markers of immune status based on cellular involvement, function or cytokine/immune mediator production such as, for example, cytokines and antibodies, or any other clinically or immunologically relevant assays.'}], 'primaryOutcomes': [{'measure': 'Adverse Events With a Causal Relationship to IMM-101', 'timeFrame': 'From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).', 'description': 'Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities. Treatment related Adverse Events were defined as being definitely, probably or possibly related to IMM-101 or with an unknown relationship.'}, {'measure': 'Treatment Emergent Adverse Events of NCI CTCAE ≥Grade 3', 'timeFrame': 'From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).', 'description': 'Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities'}, {'measure': 'Treatment Emergent Serious Adverse Events', 'timeFrame': 'From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).', 'description': 'Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities.\n\nThere were no IMM-101 related serious adverse events reported during the study.'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Overall survival was defined as the time from enrolment until date of death for up to 81 months. Patients still alive after 81 months were censored at withdrawal from the study or at last known date alive if later.', 'description': 'Overall survival'}, {'measure': 'Incidence of Change in Metastatic Disease', 'timeFrame': 'From Informed Consent to death or withdrawal (median 4.4 years, range 1.2 - 6.7)', 'description': 'The protocol required any change in metastatic disease to be documented where possible. However, given this was a real-life long-term follow-up study, CT or MRI scans were not mandated as part of the protocol and were only performed as clinically indicated. Very few scans were performed during the course of the study (0 to nine events per patient). Given the fact patients could receive anti-cancer therapy on study, disease status fluctuated throughout the study (better, worse, no change). This coupled with the sparsity of CT or MRI scan data collected on a per patient basis resulted in only Best Overall Response being described.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Melanoma']}, 'descriptionModule': {'briefSummary': 'Patients who were previously enrolled in Study IMM-101-001 and who provided informed consent were eligible to participate in this study.\n\nOnce eligibility was confirmed, a full medical history covering the period from completion of Study IMM-101-001 to date was taken.\n\nThe treatment regimen with IMM-101 was one dose given every 4 weeks or as close to this interval as permitted due to practical or logistic considerations. The dose interval could be modified at the discretion of the Investigator provided the minimum period between doses was no less than 14 days.\n\nThe overall objective was to determine the long term safety profile of IMM-101 administered intradermally for extended use.', 'detailedDescription': "This was an open-label long term follow up study. The study consisted of two phases:\n\n1. Screening and enrolment Patients, who provided informed consent participated in a screening period of up to 28 days to establish eligibility. Once eligibility was confirmed a full disease and treatment history covering the period from their completion of Study IMM-101-001 to date was taken.\n2. Treatment Patients could receive ongoing treatment every 4 weeks or as close to this interval as permitted due to practical or logistic considerations until death or withdrawal, unless such therapy was contraindicated, the patient did not wish to continue or the study was terminated by the Sponsor. At no point could the elapsed period between IMM-101 doses be less than 14 days.\n\nPatients could choose to withdraw from the study at any time and for any reason. IMM-101 could be stopped or the dosing regimen reduced if felt to be necessary by the Investigator and/or patient (e.g., intolerable injection site reactions).\n\nIn the event of an injection site reaction of Grade 3 and above, and/or if significant ulceration, tenderness or lymphadenopathy was observed, at the discretion of the Investigator, patients could be administered a half dose of the study drug (i.e., a single 0.05 mL intradermal injection of IMM-101) or the timing of the injection could be delayed. If the dosing interval was increased, the patient still attended the study site for safety assessments preferably every 3 months but, if this was not possible, every 6 months at a minimum. The blood sample for exploratory analysis continued to be taken every 6 months.\n\nAny change in the dose of study drug administered or the frequency of dose administration was recorded in the patient's case report form (CRF). In the case of withdrawal, separate consent was sought to allow the continued collection on patient status."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient was previously enrolled in Study IMM-101-001\n* Patient gave consent to make their disease and treatment history for the intervening period between their completion of Study IMM-101-001 and enrollment in this study available to the Sponsor\n* Patient gave signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* Female patient of child-bearing potential who was not, in the opinion of the Investigator, using an approved method of birth control (e.g., physical barrier \\[patient and partner\\], contraceptive pill or patch, spermicide and barrier, or intrauterine device \\[IUD\\]).\n\nThose patients that utilised hormonal contraceptives must have used the same method for at least three months before additional barrier contraception (as described above) was discontinued from being used concomitantly with the hormonal contraception.\n\n* Patient of non-child-bearing potential were defined as having 12 month amenorrhoea or were surgically sterile.\n* Female patient who was pregnant, breast feeding or planning a pregnancy during the course of the study. A pre-treatment urine pregnancy test measuring human chorionic gonadotrophin (hCG) must be negative.\n* Patient was unable or unwilling to comply with the protocol.'}, 'identificationModule': {'nctId': 'NCT01559818', 'briefTitle': 'A Long Term Follow up Study for Patients Who Previously Took Part in the Phase I Study IMM-101-001', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immodulon Therapeutics Ltd'}, 'officialTitle': 'An Open Label Long Term Follow up Study for Patients With Melanoma Who Were Previously Enrolled in the Phase I Study IMM-101-001', 'orgStudyIdInfo': {'id': 'IMM-101-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMM-101', 'description': 'IMM-101 1.0 mg administered intradermally', 'interventionNames': ['Biological: IMM-101']}], 'interventions': [{'name': 'IMM-101', 'type': 'BIOLOGICAL', 'otherNames': ['Heat-killed whole cell M. obuense'], 'description': 'IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.', 'armGroupLabels': ['IMM-101']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'St Georges University of London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Alberto Fusi, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St George's, University of London"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immodulon Therapeutics Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}