Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-22 @ 7:03 PM
Study NCT ID:
NCT03009058
Status:
TERMINATED
Last Update Posted:
2024-11-25
First Post:
2016-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': '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'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574749', 'term': 'IMM-101'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'C000711728', 'term': 'spartalizumab'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@immodulon.com', 'phone': '+44 (0)20 3137 6346', 'title': 'Chief Medical Odfficer', 'organization': 'Immodulon Therapeutics Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Only two patients were enrolled into the study before the study was terminated early by the Sponsor for commercial reasons. There were no specific safety concerns based on the data from the two patients treated. These limited data provide some preliminary indication regarding the safety and tolerability of IMM-101 when administered in combination with nivolumab. No meaningful assessment of efficacy could be made given that only two patients were enrolled into the study.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of consent until 28(±7 days) received at week 10 date which is around 3 months after the last dose of IMM-101. Serious Adverse Events were followed to resolution irrespective of the date of the last dose', 'description': 'Adverse events (including those reported spontaneously by the patient or observed by the Investigator) were recorded from the time of informed consent. All adverse events were followed until resolution, death or 30 days after the End of Study/Withdrawal visit (whichever came first). Study treatment related serious adverse events (SAEs) were recorded regardless of time from last dose.', 'eventGroups': [{'id': 'EG000', 'title': 'IMM-101 in Combination With Anti PDL1 in Melanoma', 'description': 'Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Procedural pain', 'notes': 'Head pain (at site of biopsy)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20)'}, {'term': 'Hyperthyroidism', 'notes': 'Subclinical hyperthyroid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMM-101 in Combination With Anti PDL1 in Melanoma', 'description': 'Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months.', 'description': 'Safety and tolerability will be measured by incidence and severity of adverse events (AEs), Laboratory abnormalities and local injection site reactions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Both patients were assessed'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMM-101 in Combination With Anti PDL1 in Melanoma', 'description': 'Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.\n\nA minimum of 10 patients per cohort were required for an evaluation of futility with respect to the primary activity endpoint of response to treatment (based on immune-related response criteria \\[irRC\\]). Given that only two patients were enrolled into the study, the objectives of the study described in the study protocol cannot be met.'}], 'timeFrame': 'Week 28 through study completion (maximum 4.5 years)', 'description': 'Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated before the Week 28 timepoint was reached.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMM-101 in Combination With Anti PDL1 in Melanoma', 'description': 'Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening until study termination an average of 3 months.', 'description': 'Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions to evaluate whether there is any exacerbation of toxicity normally observed with these agents', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Both patients enrolled'}, {'type': 'SECONDARY', 'title': 'Response to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMM-101 in Combination With Anti PDL1 in Melanoma', 'description': 'Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.'}], 'classes': [{'title': 'immune related Stable Disease [irSD]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'immune related Partial Response [irPR]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'immune related Complete Response [irCR]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Per protocol the initial assessment was at Week 28 then through study completion (maximum 4.5 years). Due to early termination of the study, response to treatment was measured at Week 11 for both patients', 'description': 'Response to treatment, (defined as immune related Stable Disease (irSD), immune related Partial Response (irPR) and immune related Complete Response (irCR) as assessed by the Investigator:\n\n* Immune-related Complete Response (irCR) is the disappearance of all lesions, measured or unmeasured, and no new lesions\n* Immune-related Partial Response (irPR) is a ≥50% drop in tumour burden from baseline as defined by the irRC\n* Immune-related Progressive Disease (irPD) is ≥25% increase in tumour burden from the lowest level recorded.\n* Everything else is considered immune-related Stable Disease (irSD).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMM-101 in Combination With Anti PDL1 in Melanoma', 'description': 'Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.\n\nA minimum of 10 patients per cohort were required for an evaluation of futility with respect to the primary activity endpoint of response to treatment (based on immune-related response criteria \\[irRC\\]). Given that only two patients were enrolled into the study, the objectives of the study described in the study protocol cannot be met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of randomization until date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.', 'description': 'Assessment of overall survival (defined as the time from enrolment to death due to any cause).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Assessment of overall survival (defined as the time from enrolment to death due to any cause). However, whilst 2 participants were monitored and analyzed, neither patient died before the study was terminated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IMM-101 in Combination With Anti PDL1 in Melanoma', 'description': 'Patients diagnosed with metastatic melanoma who were receiving an anti-programmed death (PD)-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Study terminated soon after initiation for commercial reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'IMM-101 in Combination With Anti PDL1 in Melanoma', 'description': 'Patients diagnosed with metastatic melanoma who were receiving an anti-programmed death-1 (PD-1) agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '63', 'upperLimit': '76'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', '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': '2', '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': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All enrolled patients'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-25', 'size': 415851, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-31T06:02', 'hasProtocol': True}, {'date': '2017-09-26', 'size': 3290396, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-31T06:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Commercial reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2016-12-16', 'resultsFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2016-12-30', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-09', 'studyFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0', 'timeFrame': 'Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months.', 'description': 'Safety and tolerability will be measured by incidence and severity of adverse events (AEs), Laboratory abnormalities and local injection site reactions.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0', 'timeFrame': 'Week 28 through study completion (maximum 4.5 years)', 'description': 'Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.'}, {'measure': 'Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor', 'timeFrame': 'From screening until study termination an average of 3 months.', 'description': 'Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions to evaluate whether there is any exacerbation of toxicity normally observed with these agents'}, {'measure': 'Response to Treatment', 'timeFrame': 'Per protocol the initial assessment was at Week 28 then through study completion (maximum 4.5 years). Due to early termination of the study, response to treatment was measured at Week 11 for both patients', 'description': 'Response to treatment, (defined as immune related Stable Disease (irSD), immune related Partial Response (irPR) and immune related Complete Response (irCR) as assessed by the Investigator:\n\n* Immune-related Complete Response (irCR) is the disappearance of all lesions, measured or unmeasured, and no new lesions\n* Immune-related Partial Response (irPR) is a ≥50% drop in tumour burden from baseline as defined by the irRC\n* Immune-related Progressive Disease (irPD) is ≥25% increase in tumour burden from the lowest level recorded.\n* Everything else is considered immune-related Stable Disease (irSD).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From date of randomization until date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.', 'description': 'Assessment of overall survival (defined as the time from enrolment to death due to any cause).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Unresectable cancer', 'pancreatic', 'melanoma', 'breast', 'lung', 'colorectal', 'cholangio', 'sarcoma'], 'conditions': ['Metastatic Cancer']}, 'descriptionModule': {'briefSummary': "During this open label study patients will receive IMM-101 in conjunction with a recognised standard of care for metastatic or unresectable cancer for the patient's specific tumour type.\n\nThe primary objective of the study is to provide safety data for IMM-101 in combination with a number of selected standard of care regimens.", 'detailedDescription': "The study will consist of three phases - Screening, Treatment and Maintenance. Patients who provide informed consent, will participate in a Screening period of up to 28 days to establish eligibility. Once eligibility is confirmed, patients will enter the Treatment Phase of the study.\n\nIn the Treatment Phase all patients will receive IMM-101 for 28 weeks.\n\nAt Week 32, if the Investigator considers it in the patients' best interest patients will progress to the Maintenance Phase of the study and will continue to be dosed every 4 weeks (or as close to this interval as permitted due to practical or logistical considerations). Patients will be followed up for assessment of safety, response to treatment, survival, and immunological markers for up to 4.5 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Metastatic or unresectable cancer and considered by their physician to be indicated for a new line of SOC as listed in the protocol\n* Are ineligible for a disease specific clinical study with IMM-101\n* Have an estimated life expectancy greater than 3 months (from Day 0)\n* Give signed informed consent for participation in the study\n* Have an Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) Performance Status of ≤2 at Day 0.\n* Have adequate bone marrow, hepatic and renal function\n\nExclusion Criteria:\n\n* Patient has previously received treatment with IMM-101\n* Patient is currently part way through a course of chemotherapy or immunotherapy\n* Patient is receiving concomitant treatment with another investigational product\n* Patient has received an investigational drug within the 4 weeks prior to IMM 101 administration\n* Patient has significant cardiovascular disease\n* Patient has any previous or concurrent malignancy (excluding adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non melanoma skin cancer, or if previous malignancy was more than 5 years prior to Screening and there are no signs of recurrence)\n* Patient has co existing active infection or medical condition which will substantially increase the risk associated with the patient's participation in the study\n* Patient has uncontrolled hypercalcaemia\n* Patient has previously experienced an allergic reaction to any mycobacterial product.\n* The patient has a history of non-infectious pneumonitis that required steroids or current pneumonitis\n* Patient has received live vaccine within 30 days of planned start of study medication\n* Patient is pregnant or a breast feeding woman.\n* Patient is unwilling to use a medically acceptable, effective method of contraception throughout the treatment period and for at least 6 months after discontinuation of treatment.\n* Patient has used depot corticosteroids in the 6 weeks before initiation of Screening\n* Patient has had chronic use of systemic corticosteroids within the 2 week period before the first administration of IMM-101\n* Patient has received a blood transfusion within 4 weeks prior to Screening\n* In the opinion of the Investigator, the patient is unable or unwilling to comply with the protocol."}, 'identificationModule': {'nctId': 'NCT03009058', 'acronym': 'MODULATE', 'briefTitle': 'Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immodulon Therapeutics Ltd'}, 'officialTitle': 'A Novel Phase I/IIa Open Label Study of IMM 101 in Combination With Selected Standard of Care (SOC) Regimens in Patients With Metastatic Cancer or Unresectable Cancer at Study Entry', 'orgStudyIdInfo': {'id': 'IMM-101-011'}, 'secondaryIdInfos': [{'id': '2016 001459 28', 'type': 'EUDRACT_NUMBER'}, {'id': 'CANC 32085', 'type': 'OTHER', 'domain': 'National Institute for Health Research (UK)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMM-101 + Gem panc ca', 'description': 'IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+Gem/nab-paclitaxel panc ca', 'description': 'IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy.\n\nThe treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+Gem+capecitabine panc ca', 'description': 'IMM-101 will be given in combination with gemcitabine + capecitabine combination therapy.\n\nThe treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Gemcitabine', 'Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101 + FOLFIRINOX panc ca', 'description': 'IMM-101 will be given in combination with standard FOLFIRINOX (FOLinic acid, Fluorouracil, IRINotecan and OXaliplatin) treatment.\n\nThe treatment regimen with IMM 101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Folinic Acid', 'Drug: Fluorouracil', 'Drug: Irinotecan', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+FOLFOX colorectal cancer (CRC)', 'description': 'IMM-101 will be given in combination with standard FOLFOX (FOLinic acid, Fluorouracil and OXaliplatin) treatment.\n\nThe treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Folinic Acid', 'Drug: Fluorouracil', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC)', 'description': 'IMM-101 will be given in combination with standard FOLFIRI (FOLinic acid, Fluorouracil and IRInotecan) + cetuximab combination treatment.\n\nThe treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Folinic Acid', 'Drug: Fluorouracil', 'Drug: Irinotecan', 'Biological: cetuximab']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+Gem cholangio', 'description': 'IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+Gem lung ca', 'description': 'IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter', 'interventionNames': ['Biological: IMM-101', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+Gem + nab-paclitaxel lung ca', 'description': 'IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy.\n\nThe treatment regimen with IMM 101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+ anti-programmed death-1 (PD1) lung ca', 'description': 'IMM-101 will be given in combination with standard treatment with either pembrolizumab or nivolumab.\n\nIn order to ensure that there are no increased immune-related adverse events (AEs), the first 3 patients entering the anti-PD1 (pembrolizumab or nivolumab) cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen.', 'interventionNames': ['Biological: IMM-101', 'Biological: Anti-PD1']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+Gem melanoma', 'description': 'IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+ anti-programmed death-1 (PD1) melanoma', 'description': 'IMM-101 will be given in combination with standard treatment with either pembrolizumab or nivolumab. The first 3 patients entering the anti-PD1 (pembrolizumab or nivolumab) cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen thereafter.', 'interventionNames': ['Biological: IMM-101', 'Biological: Anti-PD1']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+ anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) melanoma', 'description': 'IMM-101 will be given in combination with standard treatment with ipilimumab. In order to ensure that there are no increased immune-related adverse events (AEs), the first 3 patients entering the ipilimumab cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen thereafter.', 'interventionNames': ['Biological: IMM-101', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+Gem breast cancer', 'description': 'IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+Gem/ nab-paclitaxel breast', 'description': 'IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy.\n\nThe treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101 + Gem sarcoma', 'description': 'IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'IMM-101+cyclophosphamide', 'description': 'IMM-101 will be given in combination with low dose cyclophosphamide (300mg/m2 in patients with solid malignancies.\n\nThe treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.', 'interventionNames': ['Biological: IMM-101', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'IMM-101', 'type': 'BIOLOGICAL', 'otherNames': ['Heat killed M. obuense (NCTC 13365)'], 'description': 'A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365', 'armGroupLabels': ['IMM-101 + FOLFIRINOX panc ca', 'IMM-101 + Gem panc ca', 'IMM-101 + Gem sarcoma', 'IMM-101+ anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) melanoma', 'IMM-101+ anti-programmed death-1 (PD1) lung ca', 'IMM-101+ anti-programmed death-1 (PD1) melanoma', 'IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC)', 'IMM-101+FOLFOX colorectal cancer (CRC)', 'IMM-101+Gem + nab-paclitaxel lung ca', 'IMM-101+Gem breast cancer', 'IMM-101+Gem cholangio', 'IMM-101+Gem lung ca', 'IMM-101+Gem melanoma', 'IMM-101+Gem+capecitabine panc ca', 'IMM-101+Gem/ nab-paclitaxel breast', 'IMM-101+Gem/nab-paclitaxel panc ca', 'IMM-101+cyclophosphamide']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['GEMZAR'], 'description': 'Standard of Care chemotherapy', 'armGroupLabels': ['IMM-101 + Gem panc ca', 'IMM-101 + Gem sarcoma', 'IMM-101+Gem + nab-paclitaxel lung ca', 'IMM-101+Gem breast cancer', 'IMM-101+Gem cholangio', 'IMM-101+Gem lung ca', 'IMM-101+Gem melanoma', 'IMM-101+Gem+capecitabine panc ca', 'IMM-101+Gem/ nab-paclitaxel breast', 'IMM-101+Gem/nab-paclitaxel panc ca']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'otherNames': ['Abraxane'], 'description': 'Standard of Care chemotherapy', 'armGroupLabels': ['IMM-101+Gem + nab-paclitaxel lung ca', 'IMM-101+Gem/ nab-paclitaxel breast', 'IMM-101+Gem/nab-paclitaxel panc ca']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Standard of Care chemotherapy', 'armGroupLabels': ['IMM-101+Gem+capecitabine panc ca']}, {'name': 'Folinic Acid', 'type': 'DRUG', 'otherNames': ['Leucovorin'], 'description': 'Standard of Care chemotherapy', 'armGroupLabels': ['IMM-101 + FOLFIRINOX panc ca', 'IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC)', 'IMM-101+FOLFOX colorectal cancer (CRC)']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'otherNames': ['5FU'], 'description': 'Standard of Care chemotherapy', 'armGroupLabels': ['IMM-101 + FOLFIRINOX panc ca', 'IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC)', 'IMM-101+FOLFOX colorectal cancer (CRC)']}, {'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['Campto', 'Camptosar'], 'description': 'Standard of Care chemotherapy', 'armGroupLabels': ['IMM-101 + FOLFIRINOX panc ca', 'IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC)']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['Eloxatin'], 'description': 'Standard of Care chemotherapy', 'armGroupLabels': ['IMM-101 + FOLFIRINOX panc ca', 'IMM-101+FOLFOX colorectal cancer (CRC)']}, {'name': 'cetuximab', 'type': 'BIOLOGICAL', 'otherNames': ['Erbitux'], 'description': 'Standard of Care immunotherapy', 'armGroupLabels': ['IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC)']}, {'name': 'Anti-PD1', 'type': 'BIOLOGICAL', 'otherNames': ['pembrolizumab (KEYTRUDA),', 'nivolumab (OPDIVO)'], 'description': 'Standard of Care immunotherapy', 'armGroupLabels': ['IMM-101+ anti-programmed death-1 (PD1) lung ca', 'IMM-101+ anti-programmed death-1 (PD1) melanoma']}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'otherNames': ['YERVOY'], 'description': 'Standard of Care immunotherapy', 'armGroupLabels': ['IMM-101+ anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) melanoma']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['cytophosphane'], 'description': 'Standard of Care chemotherapy', 'armGroupLabels': ['IMM-101+cyclophosphamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard, Dpt Medecine & INSERM', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy Cancer Center', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': 'SW17 0RE', 'city': 'London', 'country': 'United Kingdom', 'facility': "St George's University of London, Institute of Infection and Immunity", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'David Cunningham, MD FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden Hospital Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immodulon Therapeutics Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}