Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-02-12 @ 4:18 AM
Study NCT ID:
NCT02010203
Status:
TERMINATED
Last Update Posted:
2020-02-17
First Post:
2013-12-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001500', 'term': 'BCG Vaccine'}], 'ancestors': [{'id': 'D032581', 'term': 'Tuberculosis Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lmcdermott@heatbio.com', 'phone': '9197948950', 'title': 'Lori McDermott', 'phoneExt': '9197948950', 'organization': 'Clinical Development'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase I: HS-410 Low Dose', 'description': 'In the open label Phase 1 portion, HS-410 is given as 1\\*10\\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 24, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 19, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 20, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 9, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Blood Urine Present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Hematocrit Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'White Blood Cell Count Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 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{'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Squamous Cell Carcinoma', 'notes': 'of Larynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Priapism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}, {'term': 'Bladder Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA v20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1: Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I: HS-410 Low Dose', 'description': 'HS-410 is given as 1\\*10\\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.'}], 'classes': [{'title': 'Gastrointestinal Disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'General Disorders & Administration Site Conditions', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Musculoskeletal & Connective Tissue Disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 years.', 'description': 'To evaluate the safety and tolerability of vesigenurtacel-L', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phase 2: 1-year Disease-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One year', 'description': 'Arm 1, 2, 3: 1-year DFS in patients with NMIBC treated with BCG in combination with blinded study product (one of two doses of vesigenurtacel-L or placebo) Arm 4: 1-year DFS in patients with NMIBC treat1fv 9 with high dose vesigenurtacel-L monotherapy\n\nOne-year disease-free survival will be defined as the proportion of patients who are free from recurrent disease, progressive disease, and alive one year after the date of randomization/treatment assignment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Recurrence at 3, 6, 12, 18, and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'classes': [{'title': '3 months', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'Evaluate the proportion of patients with recurrence at 3, 6, 12, 18, and 24 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Progressive Disease at 3, 6, 12, 18, and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'classes': [{'title': '3 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '18 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'Evaluate the proportion of patients with progressive disease at 3, 6, 12, 18, and 24', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival at 3, 6, 18, and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'classes': [{'title': '3 months', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'Evaluate Disease Free Survival at 3, 6, 18 and 24 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.'}, {'type': 'SECONDARY', 'title': 'Overall Disease-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'Evaluate overall Disease Free Survival', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.'}, {'type': 'SECONDARY', 'title': 'Overall Survival, Expressed as the Number of Participants Alive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'Evaluate overall survival (OS)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Undergoing Repeat Transurethral Resection of Bladder Tumor (TURBT) by 12 and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}], 'classes': [{'title': '12 Month', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Undergoing Cystectomy by 12 and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'classes': [{'title': '12 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'Evaluate the proportion of patients undergoing cystectomy by 12 and 24 months from randomization', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.'}, {'type': 'SECONDARY', 'title': 'Immunologic Response of PBMCs Via Intracellular Cytokine Staining (ICS) by Flow Cytometry and/or Enzyme-linked Immunosorbent Spot (ELISPOT) on CD8+ Cells After HS-410 Vaccination as Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'timeFrame': 'Up to 2 years', 'description': 'Evaluate the proportion of patients with immunologic response of peripheral blood mononuclear cells (PBMCs) via intracellular cytokine staining (ICS) by flow cytometry and/or ELISPOT on CD8+ cells following vesigenurtacel-L vaccination', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected as pre-specified in Outcome Measure 10 due to study termination by the Sponsor.'}, {'type': 'SECONDARY', 'title': 'Immunologic Response of Peripheral Blood Mononuclear Cells (PBMCs) and Stimulation Analysis Via ICS in Baseline and Post-treatment Biopsies, if Clinically Indicated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'timeFrame': 'Up to 3 years', 'description': 'Evaluate immunologic response of PBMCs (analysis of surface markers, CD3, CD4, CD8, CD19, CD25, CD45, CD56, FoxP3, and degranulation) and stimulation analysis via ICS of interferon gamma (IFNγ) and granzyme B (gzB)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected as pre-specified in Outcome Measure 11 due to study termination by the Sponsor.'}, {'type': 'SECONDARY', 'title': 'Total PBMC Counts by Flow Cytometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'timeFrame': 'Up to 3 years', 'description': 'Evaluate total PBMC counts by flow cytometry, including lymphocyte subsets (B cells, helper T-cells, cytotoxic T-cells, natural killer (NK) cells and T-reg)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected as pre-specified in Outcome Measure 12 due to study termination by the Sponsor.'}, {'type': 'SECONDARY', 'title': 'Tumor Antigen Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'timeFrame': 'At screening', 'description': 'Evaluation of pre-treatment tumor tissue for antigen expression', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected as pre-specified in Outcome Measure 13 due to study termination by the Sponsor.'}, {'type': 'SECONDARY', 'title': 'Tumor Infiltrating Lymphocytes (TILs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'timeFrame': 'Up to 3 years', 'description': 'Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected as pre-specified in Outcome Measure 14 due to study termination by the Sponsor.'}, {'type': 'SECONDARY', 'title': 'T Cell Receptor Sequencing of Peripheral Blood T Cells Before and During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'timeFrame': 'Up to 2 years', 'description': 'Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs, T cell receptor sequencing of peripheral blood T cells before and during the course of treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected as pre-specified in Outcome Measure 15 due to study termination by the Sponsor.'}, {'type': 'SECONDARY', 'title': 'Safety of the Combination of the HS-410 and BCG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'timeFrame': 'Up to 1 year', 'description': 'Phase 2 only Evaluate the safety of the combination of vesigenurtacel-L and BCG', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected as pre-specified in Outcome Measure 16 due to study termination by the Sponsor.'}, {'type': 'SECONDARY', 'title': 'Safety of the High Dose HS-410 Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG001', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG002', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'OG003', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'timeFrame': 'Up to 3 years.', 'description': 'Phase 2 only Evaluate the safety of high dose vesigenurtacel-L monotherapy', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected as pre-specified in Outcome Measure 17 due to study termination by the Sponsor.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase I: HS-410 Low Dose', 'description': 'In the open label Phase 1 portion, HS-410 is given as 1\\*10\\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}, {'id': 'FG001', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'FG002', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'FG003', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'FG004', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '104', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase I: HS-410 Low Dose', 'description': 'In the open label Phase 1 portion, HS-410 is given as 1\\*10\\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}, {'id': 'BG001', 'title': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'BG002', 'title': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'BG003', 'title': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.\n\nPlacebo: Injection containing sterile solution but no cells\n\nBCG: Vaccine derived from a live bacterium'}, {'id': 'BG004', 'title': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.\n\nHS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.2', 'spread': '7.495', 'groupId': 'BG000'}, {'value': '70.5', 'spread': '11.176', 'groupId': 'BG001'}, {'value': '68.58', 'spread': '11.518', 'groupId': 'BG002'}, {'value': '70.58', 'spread': '9.047', 'groupId': 'BG003'}, {'value': '72.50', 'spread': '9.784', 'groupId': 'BG004'}, {'value': '70.60', 'spread': '10.172', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '86', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '99', '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': 'BG004'}, {'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': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', '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': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '100', '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': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '104', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-03', 'size': 1496032, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-27T12:55', 'hasProtocol': True}, {'date': '2016-10-19', 'size': 1143172, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-27T12:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'whyStopped': 'Inability to accrue due to changing treatment landscape (PD-1 approvals)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2013-12-05', 'resultsFirstSubmitDate': '2019-07-31', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-13', 'studyFirstPostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Safety and Tolerability', 'timeFrame': 'Up to 3 years.', 'description': 'To evaluate the safety and tolerability of vesigenurtacel-L'}, {'measure': 'Phase 2: 1-year Disease-Free Survival', 'timeFrame': 'One year', 'description': 'Arm 1, 2, 3: 1-year DFS in patients with NMIBC treated with BCG in combination with blinded study product (one of two doses of vesigenurtacel-L or placebo) Arm 4: 1-year DFS in patients with NMIBC treat1fv 9 with high dose vesigenurtacel-L monotherapy\n\nOne-year disease-free survival will be defined as the proportion of patients who are free from recurrent disease, progressive disease, and alive one year after the date of randomization/treatment assignment'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients With Recurrence at 3, 6, 12, 18, and 24 Months', 'timeFrame': 'Up to 2 years', 'description': 'Evaluate the proportion of patients with recurrence at 3, 6, 12, 18, and 24 months'}, {'measure': 'Proportion of Patients With Progressive Disease at 3, 6, 12, 18, and 24 Months', 'timeFrame': 'Up to 2 years', 'description': 'Evaluate the proportion of patients with progressive disease at 3, 6, 12, 18, and 24'}, {'measure': 'Disease-free Survival at 3, 6, 18, and 24 Months', 'timeFrame': 'Up to 2 years', 'description': 'Evaluate Disease Free Survival at 3, 6, 18 and 24 months'}, {'measure': 'Overall Disease-free Survival', 'timeFrame': 'Up to 3 years', 'description': 'Evaluate overall Disease Free Survival'}, {'measure': 'Overall Survival, Expressed as the Number of Participants Alive', 'timeFrame': 'Up to 3 years', 'description': 'Evaluate overall survival (OS)'}, {'measure': 'Proportion of Patients Undergoing Repeat Transurethral Resection of Bladder Tumor (TURBT) by 12 and 24 Months', 'timeFrame': 'Up to 2 years'}, {'measure': 'Proportion of Patients Undergoing Cystectomy by 12 and 24 Months', 'timeFrame': 'Up to 2 years', 'description': 'Evaluate the proportion of patients undergoing cystectomy by 12 and 24 months from randomization'}, {'measure': 'Immunologic Response of PBMCs Via Intracellular Cytokine Staining (ICS) by Flow Cytometry and/or Enzyme-linked Immunosorbent Spot (ELISPOT) on CD8+ Cells After HS-410 Vaccination as Compared to Baseline.', 'timeFrame': 'Up to 2 years', 'description': 'Evaluate the proportion of patients with immunologic response of peripheral blood mononuclear cells (PBMCs) via intracellular cytokine staining (ICS) by flow cytometry and/or ELISPOT on CD8+ cells following vesigenurtacel-L vaccination'}, {'measure': 'Immunologic Response of Peripheral Blood Mononuclear Cells (PBMCs) and Stimulation Analysis Via ICS in Baseline and Post-treatment Biopsies, if Clinically Indicated', 'timeFrame': 'Up to 3 years', 'description': 'Evaluate immunologic response of PBMCs (analysis of surface markers, CD3, CD4, CD8, CD19, CD25, CD45, CD56, FoxP3, and degranulation) and stimulation analysis via ICS of interferon gamma (IFNγ) and granzyme B (gzB)'}, {'measure': 'Total PBMC Counts by Flow Cytometry', 'timeFrame': 'Up to 3 years', 'description': 'Evaluate total PBMC counts by flow cytometry, including lymphocyte subsets (B cells, helper T-cells, cytotoxic T-cells, natural killer (NK) cells and T-reg)'}, {'measure': 'Tumor Antigen Expression', 'timeFrame': 'At screening', 'description': 'Evaluation of pre-treatment tumor tissue for antigen expression'}, {'measure': 'Tumor Infiltrating Lymphocytes (TILs)', 'timeFrame': 'Up to 3 years', 'description': 'Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs'}, {'measure': 'T Cell Receptor Sequencing of Peripheral Blood T Cells Before and During Treatment', 'timeFrame': 'Up to 2 years', 'description': 'Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs, T cell receptor sequencing of peripheral blood T cells before and during the course of treatment.'}, {'measure': 'Safety of the Combination of the HS-410 and BCG', 'timeFrame': 'Up to 1 year', 'description': 'Phase 2 only Evaluate the safety of the combination of vesigenurtacel-L and BCG'}, {'measure': 'Safety of the High Dose HS-410 Monotherapy', 'timeFrame': 'Up to 3 years.', 'description': 'Phase 2 only Evaluate the safety of high dose vesigenurtacel-L monotherapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['TURBT', 'Bladder', 'Cancer', 'GP96', 'Vaccine', 'Immunotherapy', 'Heat Biologics', 'BCG', 'Bacillus Calmette-Guerin', 'Bacillus Calmette-Guérin'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'Phase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1\\*10\\^6 cells) HS-410 monotherapy. Phase 2, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1\\*10\\^6 cells) or high dose (1\\*10\\^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. Patients who do not receive BCG will be enrolled into an open-label, non-randomized group receiving high dose (1\\*10\\^7 cells) intradermal HS-410 monotherapy.', 'detailedDescription': 'This study is a two part study: Phase I and Phase II. The Phase 1 portion is an open-label, safety study. Patients will have previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1\\*10\\^6 cells) HS-410 monotherapy. In Phase 2, patients will be assigned to treatment groups based on whether they will receive induction BCG in the typical post-TURBT window. If the investigator plans to administer BCG, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1\\*10\\^6 cells) or high dose (1\\*10\\^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. If patients will not receive BCG, they will be enrolled into an open-label, non-randomized group and receive high dose (1\\*10\\^7 cells) intradermal HS-410 monotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed non-muscle invasive bladder cancer \\[Ta, T1 or Tis (CIS)\\] that has been removed by transurethral resection\n* Either: (i) high-risk disease, defined as T1 and/or high-grade and/or CIS or (ii) intermediate-risk disease, defined as Ta low-grade with at least 3 of the following 4 risk factors: multiple tumors, tumor size \\> 3cm, early recurrence (\\<1 year from previous staging procedure), or recurrence with a frequency of more than once in any 12 month period\n* Not have received bacillus Calmette-Guérin (BCG) or have completed previous BCG treatment \\> 12 months prior to the baseline staging procedure.\n* Phase 2 Arms 1-3: Suitable to receive a 6-week course of BCG in the adjuvant setting within 6 weeks following TURBT. Phase 2 Arm 4: Suitable for monotherapy vaccine administration post-TURBT. For Phase 1 only: Has previously received 3-6 weekly doses of BCG.\n* Adequate laboratory parameters\n\nExclusion Criteria:\n\n* Human immunodeficiency virus (HIV) infection or immunodeficiency disorders, either primary or acquired\n* Infections or intercurrent illness requiring active therapy\n* Any condition requiring active steroid or other immunosuppressive therapy\n* Active malignancies within the past 12 months except negligible risk of metastasis or death treated with expected curative outcome.\n* Prostate pelvic radiation within the past 12 months\n* Significant cardiac impairment\n* Current alcohol or chemical abuse, or mental or psychiatric condition precluding protocol compliance\n* Pregnant or nursing\n* Allergy to soy, egg, or peanut products\n* Receiving another investigational agent (30 day wash-out required prior to first dose)\n* Neo-adjuvant therapy prior to baseline staging procedures for the current occurrence of non-muscle invasive bladder cancer\n* Prior treatment with a cancer vaccine for this indication\n* Prior vaccination with BCG for tuberculosis disease\n* Prior splenectomy'}, 'identificationModule': {'nctId': 'NCT02010203', 'briefTitle': 'A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heat Biologics'}, 'officialTitle': 'Phase 1/2, Placebo-Controlled, Randomized Study to Evaluate the Safety, Immune Response & Clinical Activity of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer Who Have Undergone Transurethral Resection of Bladder Tumor (TURBT)', 'orgStudyIdInfo': {'id': 'HS410-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase I: HS-410 Low Dose', 'description': 'In the open label Phase 1 portion, HS-410 is given as 1\\*10\\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.', 'interventionNames': ['Biological: HS-410']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II: HS-410 Low-Dose Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.', 'interventionNames': ['Biological: HS-410', 'Biological: BCG']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II: High-Dose HS-410 Plus BCG', 'description': 'In the Phase 2 portion, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.', 'interventionNames': ['Biological: HS-410', 'Biological: BCG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase II: Placebo Plus BCG', 'description': 'In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.', 'interventionNames': ['Biological: Placebo', 'Biological: BCG']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II: High-Dose HS-410', 'description': 'In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\\*10\\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.', 'interventionNames': ['Biological: HS-410']}], 'interventions': [{'name': 'HS-410', 'type': 'BIOLOGICAL', 'description': 'Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96', 'armGroupLabels': ['Phase I: HS-410 Low Dose', 'Phase II: HS-410 Low-Dose Plus BCG', 'Phase II: High-Dose HS-410', 'Phase II: High-Dose HS-410 Plus BCG']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Injection containing sterile solution but no cells', 'armGroupLabels': ['Phase II: Placebo Plus BCG']}, {'name': 'BCG', 'type': 'BIOLOGICAL', 'otherNames': ['Bacillus Calmette-Guerin'], 'description': 'Vaccine derived from a live bacterium', 'armGroupLabels': ['Phase II: HS-410 Low-Dose Plus BCG', 'Phase II: High-Dose HS-410 Plus BCG', 'Phase II: Placebo Plus BCG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91411', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Skyline Urology', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Skyline Urology', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80211', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Urology Center of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United 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