Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 3:58 PM
Study NCT ID:
NCT03712358
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2018-10-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PVSRIPO for Patients With Unresectable Melanoma
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lfranklin@istarioncology.com', 'phone': '919-245-7662', 'title': 'Lisa Franklin', 'organization': 'Istari Oncology'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "From signing the informed consent form until the participant's end of study visit, up to 2 years", 'description': 'The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 0 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion.\n\nPVSRIPO: Intralesional injection of PVSRIPO.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 3 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 4 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.\n\nPVSRIPO: Intralesional injection of PVSRIPO.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'incisional drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'rash macro-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients With Dose Limiting Toxicity by Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG001', 'title': 'Cohort 1 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG002', 'title': 'Cohort 2 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG003', 'title': 'Cohort 3 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG004', 'title': 'Cohort 4 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'To characterize the safety and tolerability of PVSRIPO in American Joint Committee on Cancer (AJCC) Stage IIIB, IIIC, or IV melanoma.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study closed to enrollment due to business decision prior to enrolling Cohort 4.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Response Rates Via Measurement of Cutaneous Lesions Every 3 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG001', 'title': 'Cohort 1 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG002', 'title': 'Cohort 2 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG003', 'title': 'Cohort 3 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG004', 'title': 'Cohort 4 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}], 'classes': [{'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'immune-related Partial Response (irPR)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'immune related Stable Disease (irSD)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'To describe the response rates via lesion size of PVSRIPO-injected versus non-injected lesion(s) as defined per the investigator using immune related response criteria (irRC).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on immune-related response criteria (irRC).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of CD8 Positive T Cells by Immunohistochemistry on Pre Treatment and Post Treatment Biopsy (Cohorts 0-3 Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG001', 'title': 'Cohort 1 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG002', 'title': 'Cohort 2 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG003', 'title': 'Cohort 3 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG004', 'title': 'Cohort 4 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'title': 'Absent', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Sparse', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Dense', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing data', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Post-treatment', 'categories': [{'title': 'Absent', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Sparse', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Dense', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing data', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4.1 months', 'description': 'To describe the number of CD8 positive T cells present in the tumor biopsies before and after injection of PVSRIPO.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 4 not enrolled'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Change in Tumor Pathology From Baseline to After PVSRIPO Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG001', 'title': 'Cohort 1 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG002', 'title': 'Cohort 2 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG003', 'title': 'Cohort 3 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG004', 'title': 'Cohort 4 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}], 'classes': [{'title': 'No response', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Complete response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4.1 months', 'description': 'Determine the pathologic response in tumor biopsies after PVSRIPO by confirming presence or absence of viable tumor cells.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Insufficient sample for analysis and Cohort 4 not enrolled'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Detection of Viral Replication in Injected Versus Non Injected Lesions (Cohorts 0-3 Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG001', 'title': 'Cohort 1 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG002', 'title': 'Cohort 2 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG003', 'title': 'Cohort 3 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG004', 'title': 'Cohort 4 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}], 'timeFrame': '4.1 months', 'description': 'Determine viral replication via a number of methods (e.g., qRT-PCR, ICH).', 'reportingStatus': 'POSTED', 'populationDescription': 'Insufficient sample for analysis and Cohort 4 not enrolled'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Change in Inflammatory Cells and Markers After PVSRIPO in Injected Versus Non Injected Lesions (Cohorts 0-3 Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG001', 'title': 'Cohort 1 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG002', 'title': 'Cohort 2 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG003', 'title': 'Cohort 3 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG004', 'title': 'Cohort 4 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}], 'timeFrame': '4.1 months', 'description': 'Determine changes in the tumor microenvironment from biopsies after PVSRIPO; includes but not limited to examination of CD8, PVR (CD155), PD-L1, CD4, FoxPE, and PD-1.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this measure'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change Relative to Baseline in Type and/or Function of T Cells Via Flow Cytometry (Cohorts 0-3 Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG001', 'title': 'Cohort 1 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG002', 'title': 'Cohort 2 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG003', 'title': 'Cohort 3 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'OG004', 'title': 'Cohort 4 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '10315', 'groupId': 'OG000', 'lowerLimit': '799', 'upperLimit': '18923'}, {'value': '7879', 'groupId': 'OG001', 'lowerLimit': '725', 'upperLimit': '13932'}, {'value': '39776', 'groupId': 'OG002', 'lowerLimit': '10557', 'upperLimit': '86395'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '5949', 'groupId': 'OG000', 'lowerLimit': '903', 'upperLimit': '10996'}, {'value': '20574', 'groupId': 'OG001', 'lowerLimit': '9452', 'upperLimit': '31697'}, {'value': '102332', 'groupId': 'OG002', 'lowerLimit': '55708', 'upperLimit': '148957'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Describe how systemic immune cell populations may change after treatment with PVSRIPO.', 'unitOfMeasure': 'cells per 200,000 events', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 3 missing data; Cohort 4 not enrolled'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 0 (PVSRIPO)', 'description': 'A single dose of 1.0 x 10\\^8 TCID50 PVSRIPO into a single lesion.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'FG001', 'title': 'Cohort 1 (PVSRIPO)', 'description': 'A single dose of 1.0 x 10\\^8 TCID50 PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.Total dose 2.0 x 10\\^8 TCID50.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'FG002', 'title': 'Cohort 2 (PVSRIPO)', 'description': 'A single dose of 1.0 x 10\\^8 TCID50 PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines. Total dose 3.0 x 10\\^8 TCID50.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'FG003', 'title': 'Cohort 3 (PVSRIPO)', 'description': 'A single dose of 1.0 x 10\\^8 TCID50 PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines. Total dose of 3.0 x 10\\^8 TCID50 PVSRIPO.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'FG004', 'title': 'Cohort 4 (PVSRIPO)', 'description': 'A single dose of 1.0 x 10\\^8 TCID50 PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 0 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'BG001', 'title': 'Cohort 1 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'BG002', 'title': 'Cohort 2 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'BG003', 'title': 'Cohort 3 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'BG004', 'title': 'Cohort 4 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.\n\nPVSRIPO: Intralesional injection of PVSRIPO.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '10.69', 'groupId': 'BG000'}, {'value': '59.7', 'spread': '19.55', 'groupId': 'BG001'}, {'value': '70.3', 'spread': '4.62', 'groupId': 'BG002'}, {'value': '71.0', 'spread': '7.81', 'groupId': 'BG003'}, {'value': '65.4', 'spread': '11.64', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Study closed to enrollment due to business decision prior to enrolling Cohort 4.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-29', 'size': 1971369, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-09T15:11', 'hasProtocol': True}, {'date': '2020-05-29', 'size': 261909, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-09T15:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Study closed to enrollment due to business decision prior to enrolling Cohort 4', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2018-10-05', 'resultsFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2018-10-17', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-04', 'studyFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Response Rates Via Measurement of Cutaneous Lesions Every 3 Weeks', 'timeFrame': '24 months', 'description': 'To describe the response rates via lesion size of PVSRIPO-injected versus non-injected lesion(s) as defined per the investigator using immune related response criteria (irRC).'}, {'measure': 'Number of CD8 Positive T Cells by Immunohistochemistry on Pre Treatment and Post Treatment Biopsy (Cohorts 0-3 Only)', 'timeFrame': '4.1 months', 'description': 'To describe the number of CD8 positive T cells present in the tumor biopsies before and after injection of PVSRIPO.'}, {'measure': 'The Change in Tumor Pathology From Baseline to After PVSRIPO Injection', 'timeFrame': '4.1 months', 'description': 'Determine the pathologic response in tumor biopsies after PVSRIPO by confirming presence or absence of viable tumor cells.'}, {'measure': 'The Detection of Viral Replication in Injected Versus Non Injected Lesions (Cohorts 0-3 Only)', 'timeFrame': '4.1 months', 'description': 'Determine viral replication via a number of methods (e.g., qRT-PCR, ICH).'}, {'measure': 'The Change in Inflammatory Cells and Markers After PVSRIPO in Injected Versus Non Injected Lesions (Cohorts 0-3 Only)', 'timeFrame': '4.1 months', 'description': 'Determine changes in the tumor microenvironment from biopsies after PVSRIPO; includes but not limited to examination of CD8, PVR (CD155), PD-L1, CD4, FoxPE, and PD-1.'}, {'measure': 'Change Relative to Baseline in Type and/or Function of T Cells Via Flow Cytometry (Cohorts 0-3 Only)', 'timeFrame': '24 months', 'description': 'Describe how systemic immune cell populations may change after treatment with PVSRIPO.'}], 'primaryOutcomes': [{'measure': 'Proportion of Patients With Dose Limiting Toxicity by Cohort', 'timeFrame': '24 months', 'description': 'To characterize the safety and tolerability of PVSRIPO in American Joint Committee on Cancer (AJCC) Stage IIIB, IIIC, or IV melanoma.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '37072349', 'type': 'DERIVED', 'citation': 'Brown MC, Beasley GM, McKay ZP, Yang Y, Desjardins A, Randazzo DM, Landi D, Ashley DM, Bigner DD, Nair SK, Gromeier M. Intratumor childhood vaccine-specific CD4+ T-cell recall coordinates antitumor CD8+ T cells and eosinophils. J Immunother Cancer. 2023 Apr;11(4):e006463. doi: 10.1136/jitc-2022-006463.'}, {'pmid': '36175036', 'type': 'DERIVED', 'citation': 'Beasley GM, Brown MC, Farrow NE, Landa K, Al-Rohil RN, Selim MA, Therien AD, Jung SH, Gao J, Boczkowski D, Holl EK, Salama AKS, Bigner DD, Gromeier M, Nair SK. Multimodality analysis confers a prognostic benefit of a T-cell infiltrated tumor microenvironment and peripheral immune status in patients with melanoma. J Immunother Cancer. 2022 Sep;10(9):e005052. doi: 10.1136/jitc-2022-005052.'}, {'pmid': '33875611', 'type': 'DERIVED', 'citation': 'Beasley GM, Nair SK, Farrow NE, Landa K, Selim MA, Wiggs CA, Jung SH, Bigner DD, True Kelly A, Gromeier M, Salama AK. Phase I trial of intratumoral PVSRIPO in patients with unresectable, treatment-refractory melanoma. J Immunother Cancer. 2021 Apr;9(4):e002203. doi: 10.1136/jitc-2020-002203.'}]}, 'descriptionModule': {'briefSummary': 'This study is a Phase I study of oncolytic polio/rhinovirus recombinant (PVSRIPO) to primarily characterize the safety and tolerability of PVSRIPO in patients with AJCC Stage IIIB, IIIC, or IV melanoma in a modified 3+3 phase 1 trial design. Lesion biopsies and blood samples will be obtained pre- and post-injection throughout the study for routine histology/molecular genetic testing and immunologic analysis, respectively. Exploratory objectives include describing the response rates of PVSRIPO-injected versus non-injected lesion(s), the number of CD8 positive T cells present in the tumor biopsies before and after injection of PVSRIPO, and after PVSRIPO administration: the pathologic response in tumor biopsies, changes in the tumor microenvironment, and how systemic immune cell populations may change.', 'detailedDescription': 'The Primary Objective of the study is to determine the safety profile of PVSRIPO in Stage IIIB, IIIC, and IV recurrent melanoma patients as determined by dose-limiting toxicities (DLT) by cohort, as well as in those retreated with PVSRIPO, when PVSRIPO is injected intralesionally into 1 to 3 or more cutaneous or subcutaneous lesions. As planned, up to 18 patients may be treated with PVSRIPO.\n\nBiopsy material will be obtained from tumor tissue prior to and following virus administration, which may be subjected to routine histology along with molecular genetic testing and evaluation of pathological response. Whole blood for immunologic analyses will also be collected throughout the study period.\n\nRoutine study visits will occur through Day 126. Thereafter, visits will occur every 2-3 months for up to 2 years for subjects who do not progress. For patients with progressive disease, chart review only will occur every 3 months starting at the time of progression.\n\nPatients who previously participated in Cohorts 0 through 3, who in the opinion of the investigator, may benefit from continued PVSRIPO administration, may be eligible to receive additional injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Undergone prior vaccination against PV and received a boost immunization with trivalent IPOL® (Sanofi-Pasteur SA) at least 1 week, but less than 6 weeks, prior to administration of PVSRIPO (within 6 months of PVSRIPO retreatment).\n\n a. Note: Patients who are unsure of their prior vaccination status/who have not been vaccinated must provide proof of vaccination and/or evidence of anti-PV immunity prior to enrollment, as applicable.\n2. The patient must have received a boost immunization with trivalent inactivated IPOL™ (Sanofi-Pasteur) at least 1 week prior to administration of the study agent.\n3. Patient must have histologically proven unresectable, recurrent, melanoma, stage IIIB, IIIC, or stage IV (AJCC staging must be documented in patient's medical record, as determined by CT of the chest, abdomen and pelvis, and/or whole body positron emission tomography (PET) scan, and MRI of the brain within 4 weeks prior to administration of study drug).\n4. Patients with BRAF mutations, must have failed at least 2 lines of therapy, specifically one BRAF targeted therapy and at least one anti-PD-1 based therapy. For BRAF wild type, patients must have failed at least one anti-PD-1 based therapy.\n5. Patient must be ≥ 18 years of age.\n6. Patient must have an Eastern Cooperative Oncology Group (ECOG) / Zubrod status of 0-1.\n7. Patient's disease must be bi-dimensionally measurable by caliper or radiological method as defined in the immune-related response criteria (irRC).\n8. At least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion ≥ 10 mm in longest diameter or, multiple injectable melanoma lesions which in aggregate have a longest diameter of ≥ 10 mm (Cohorts 0 and possibly 1). For cohorts where 2 or 3 injections are planned (Cohorts 1 and 2), the patient must have at least 2 injectable melanoma lesions (when 2 doses are planned) or ≥3 injectable melanoma lesions when at least 3 doses are planned in different lesions (Cohorts 2 through 4).\n\n a. Note: PVSRIPO retreatment requires ≥2 lesions amenable to injection.\n9. At least one measurable lesion that will not be injected.\n10. Serum lactate dehydrogenase (LDH) levels less than 1.5 x upper limit of normal (ULN).\n11. Patient must have adequate bone marrow, liver and renal function as assessed by the following:\n\n 1. Hemoglobin \\> 9.0 g/dl\n 2. White blood count (WBC) of \\> 2000 m3\n 3. Absolute neutrophil count (ANC) \\> 1,000/mm3\n 4. Platelet count \\> 75,000/mm3\n 5. Total bilirubin \\< 2.0 x ULN\n 6. Alanine aminotransferse (ALT) and aspartate aminotransferance (AST) \\< 2.5 x the ULN\n\nExclusion Criteria:\n\n1. Females who are pregnant or breast-feeding.\n2. Adults of reproductive potential not employing an effective method of birth control.\n3. Patients with severe, active co-morbidity, defined as follows:\n\n 1. Patients with an active infection requiring treatment or having an unexplained febrile illness (Tmax \\> 99.5°F/37.5°C).\n 2. Patients with impaired cardiac function or clinically significant cardiac disease, such as congestive heart failure requiring treatment (New York Heart Association Class ≥ 2), uncontrolled hypertension or clinically significant arrhythmia; QTcF \\> 470 msec on ECG if performed or congenital long QT syndrome; acute myocardial infarction or unstable angina pectoris \\< 3 months prior to study.\n 3. Patients with known lung (FEV1 \\< 50%) disease or uncontrolled diabetes mellitus (HgbA1c\\>7).\n 4. Patients with albumin allergy.\n 5. Autoimmune disease: History of or current active autoimmune diseases, \\[e.g. including but not limited to inflammatory bowel diseases \\[IBD\\], rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (such as Guillain-Barre syndrome)\\]. Vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism are not exclusionary.\n 6. Known immunosuppressive disease, human immunodeficiency virus (HIV) infection, or chronic Hepatitis B or C.\n4. Patients with a previous history of neurological complications due to PV infection.\n5. Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy. Guidelines for this recovery period are dependent upon the specific therapeutic agent being used. Toxicities must have resolved to CTCAE grade 1 or less with the following exceptions (alopecia, fatigue, vitiligo).\n6. Patients with undetectable anti-tetanus toxoid IgG.\n7. Patients with known history of agammaglobulinemia.\n8. Patients on greater than 10 mg per day of prednisone within the 2 weeks prior to admission for PVSRIPO injection.\n9. Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups).\n10. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin.\n11. Clinically active cerebral or bone metastases.\n12. Greater than 3 visceral metastases (this does not include nodal metastases associated with visceral organs).\n13. Prior allogeneic stem cell transplantation.\n14. Concomitant therapy with any of the following: IL-2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses). However, during the course of the study, use of corticosteroids is allowed if used for treating immune related adverse events (irAE), adrenal insufficiencies, or if administered at doses of prednisone 10 mg daily or equivalent.\n15. Active clinically serious infection \\> CTCAE Grade 2.\n16. Antineoplastic therapy, radiotherapy, or any other investigational drug within 15 days prior to first study drug administration."}, 'identificationModule': {'nctId': 'NCT03712358', 'briefTitle': 'PVSRIPO for Patients With Unresectable Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Istari Oncology, Inc.'}, 'officialTitle': 'A Phase I Trial of PVSRIPO for Patients With Unresectable Melanoma', 'orgStudyIdInfo': {'id': 'Pro00090774'}, 'secondaryIdInfos': [{'id': 'K08CA237726', 'link': 'https://reporter.nih.gov/quickSearch/K08CA237726', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 0 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion.', 'interventionNames': ['Biological: PVSRIPO']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.', 'interventionNames': ['Biological: PVSRIPO']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.', 'interventionNames': ['Biological: PVSRIPO']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.', 'interventionNames': ['Biological: PVSRIPO']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4 (PVSRIPO)', 'description': 'A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.', 'interventionNames': ['Biological: PVSRIPO']}], 'interventions': [{'name': 'PVSRIPO', 'type': 'BIOLOGICAL', 'description': 'Intralesional injection of PVSRIPO.', 'armGroupLabels': ['Cohort 0 (PVSRIPO)', 'Cohort 1 (PVSRIPO)', 'Cohort 2 (PVSRIPO)', 'Cohort 3 (PVSRIPO)', 'Cohort 4 (PVSRIPO)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Lisa Franklin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istari Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istari Oncology, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}