Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-07 @ 8:17 AM
Study NCT ID:
NCT03165994
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723517', 'term': 'sotigalimab'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@pyxisoncology.com', 'phone': '(339) 545 8252', 'title': 'Pyxis Oncology Clinical Operations', 'organization': 'Pyxis Oncology, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks.', 'description': 'All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.', 'eventGroups': [{'id': 'EG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 33, 'seriousNumAtRisk': 33, 'deathsNumAffected': 7, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 40, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 28, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oesophageal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 41, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 31, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 29, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 39, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 35, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 17, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 17, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 26, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 23, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 17, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumatosis intestinalis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Chylothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pathologic Complete Response (pCR) Rate (%) Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '57.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'The pCR was defined as post-neoadjuvant pathologic tumour, node, metastasis (ypTNM) (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator.\n\n* T0: No evidence of primary tumor.\n* N0: Cancer has not spread to nearby lymph nodes.\n\nAn exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.'}, {'type': 'PRIMARY', 'title': 'pCR Rate (%) by Baseline Histologic Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'classes': [{'title': 'Squamous Cell Carcinoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '94.7'}]}]}, {'title': 'Adenocarcinoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '15.6', 'upperLimit': '55.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator.\n\nAn exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.'}, {'type': 'PRIMARY', 'title': 'pCR Rate (%) by Baseline Tumor Location Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'classes': [{'title': 'GE Junction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '58.1'}]}]}, {'title': 'Non-GE Junction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '73.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator.\n\nAn exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.'}, {'type': 'PRIMARY', 'title': 'pCR Rate (%) by Steroid Use Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'classes': [{'title': 'Steroid Use: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '58.7'}]}]}, {'title': 'Steroid Use: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '74.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. Steroids use: Yes was defined as participants with any steroid (ATC2 class corticosteroids for systemic use) from within 30 days of the first dose of sotigalimab to up to 7 days after the first dose and participants not fulfilling previous requirements are defined as Steroids use: No.\n\nAn exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.'}, {'type': 'PRIMARY', 'title': 'pCR Rate (%) by Surgery Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'classes': [{'title': 'Surgery Before or at Week 16-17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '52.2'}]}]}, {'title': 'Surgery After Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '91.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator.\n\nThe subgroup of participants who had surgery before or at 16/17 weeks were defined as start of study treatment to surgery date from the surgical resection form, less than or equal to 17 weeks (119 days = 17 weeks \\* 7 days) or participants who were scheduled to have surgery but had their procedure aborted due to progressive disease at the time of the procedure or immediately before and did not have surgery because of metastasis. The subgroup of participants who had surgery after Week 17 were defined as start of study treatment to surgery date from the surgical resection form, greater than 17 weeks.\n\nAn exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.'}, {'type': 'SECONDARY', 'title': 'Rate (%) of R0 Resection Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'R0 was defined as the absence of gross and microscopic tumor involvement in the surgical margins i.e., no tumor remains following surgery. Rate of R0 resection was defined as the percentage of participants who achieved R0 following surgical resection.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.'}, {'type': 'SECONDARY', 'title': 'Rate (%) of R0 Resection by Baseline Histologic Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'classes': [{'title': 'Squamous Cell Carcinoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Adenocarcinoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'R0 was defined as the absence of gross and microscopic tumor involvement in the surgical margins i.e., no tumor remains following surgery. Rate of R0 resection was defined as the percentage of participants who achieved R0 following surgical resection.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.'}, {'type': 'SECONDARY', 'title': 'Pathologic Stage at Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'classes': [{'title': 'Tumor Stage: Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Tumor Stage: T0', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Tumor Stage: T1a', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Tumor Stage: T2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Tumor Stage: T3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Node Stage: Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Node Stage: N0', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Node Stage: N1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Node Stage: N2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Node Stage: N3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis Stage: Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Metastasis Stage: M0', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Stage Group: Missing', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Stage Group: I', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Stage Group: IA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Stage Group: II', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Stage Group: III', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Stage Group: IIIA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Stage Group: IIIB', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Stage Group: IVA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'Pathologic staging was assessed via ypTNM (after chemoRT and surgery):\n\n* Tumor Stage (TX, T0, T1, T1a, T1b, T2, T3, T4, T4a, T4b) refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it had grown into the wall of the esophagus.\n* Node Stage (NX, N0, N1, N2, N3) refers to the number and location of lymph nodes that cancer has spread to. The higher the number after the N, the more lymph nodes that contained cancer cells.\n* Metastasis Stage (M0, M1) refers to whether the cancer had not spread (M0) or spread (M1) to other parts of the body.\n* Stage group (0, I, IA, IB, II, IIA, IIB, III, IIIA, IIIB, IV, IVA, IVB) are based on the TNM stages detailed above. The higher the number, the more advanced the cancer was.\n\nFor each category, a lower stage/group represents a better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.'}, {'type': 'SECONDARY', 'title': 'Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'classes': [{'title': 'At Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Postoperative Follow-up/Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Postoperative Follow-up/Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'End of Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively)', 'description': 'Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas.\n\nAs the population does not typically have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST), radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. Participants with data available at each time point are presented. Participants included at End of Study Visit discontinued prior to completion of Postoperative Follow-up/Month 6.'}, {'type': 'SECONDARY', 'title': 'Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'classes': [{'title': 'Squamous Cell Carcinoma: At Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Squamous Cell Carcinoma: Postoperative Follow-up/Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Squamous Cell Carcinoma: Postoperative Follow-up/Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Squamous Cell Carcinoma: End of Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adenocarcinoma: At Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Adenocarcinoma: Postoperative Follow-up/Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Adenocarcinoma: Postoperative Follow-up/Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adenocarcinoma: End of Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively)', 'description': 'Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas.\n\nAs the population does not typically have measurable disease by RECIST, radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. Participants with data available at each time point are presented. Participants included at End of Study Visit discontinued prior to completion of Postoperative Follow-up/Month 6.'}, {'type': 'SECONDARY', 'title': 'Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'classes': [{'title': 'GE Junction: At Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GE Junction: Postoperative Follow-up/Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'GE Junction: Postoperative Follow-up/Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GE Junction: End of Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non-GE Junction: At Time of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Non-GE Junction: Postoperative Follow-up/Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Non-GE Junction: Postoperative Follow-up/Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Non-GE Junction: End of Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Responding', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stable/Unchanged', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Progressing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively)', 'description': 'Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas.\n\nAs the population does not typically have measurable disease by RECIST, radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. Participants with data available at each time point are presented. Participants included at End of Study Visit discontinued prior to completion of Postoperative Follow-up/Month 6.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 20 weeks', 'description': 'TEAEs were defined as adverse events which started on or after the first infusion of study treatment (Carboplatin/Paclitaxel/Sotigalimab/Radiotherapy) until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first. Laboratory values that were considered clinically significant were reported as adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: All participants who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (area under the carboplatin plasma concentration versus time curve \\[AUC\\] = 2) and paclitaxel (50 mg/m\\^2) chemotherapy intravenously (IV) over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Confirmed Radiographic Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Non-Compliance With Study Treatment or Procedure Requirements', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision, other than adverse event (AE)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Participant or Legal Representative Withdraws Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 34 participants were eligible for the study, of which 33 received treatment in the study, in the United States between October 2017 and February 2023.', 'preAssignmentDetails': 'The study consisted of:\n\n* Screening Period (within 28 days of Treatment Period Day 1).\n* Treatment Period (Weeks 1-6) sotigalimab with standard-of-care (SOC) chemoradiation (chemoRT) consisting of external beam radiation in daily fractions, with concurrent weekly low-dose carboplatin/paclitaxel.\n* Post-treatment Period inc. surgery (Weeks 7-17).\n* Post-operative Follow-up Period (Months 1, 3, and 6 post-operatively).\n* Overall Survival Follow-up Period (every 3 months for 18 months).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sotigalimab With SOC ChemoRT', 'description': 'Participants received SOC chemoRT, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).\n\nSurgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '9.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Black or African', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor Histology', 'classes': [{'categories': [{'title': 'Squamous Cell Carcinoma', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Adenocarcinoma', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor Location', 'classes': [{'categories': [{'title': 'GE Junction', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Non-GE Junction', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Non-gastroesophageal (GE) Junction tumor location includes upper, middle, and lower thirds of the esophagus.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population: All participants who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-17', 'size': 1301658, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-15T06:35', 'hasProtocol': True}, {'date': '2023-03-08', 'size': 614788, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-15T06:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Non-comparative, open-label pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2017-05-23', 'resultsFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-04', 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic Complete Response (pCR) Rate (%) Overall', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'The pCR was defined as post-neoadjuvant pathologic tumour, node, metastasis (ypTNM) (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator.\n\n* T0: No evidence of primary tumor.\n* N0: Cancer has not spread to nearby lymph nodes.\n\nAn exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.'}, {'measure': 'pCR Rate (%) by Baseline Histologic Subgroup', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator.\n\nAn exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.'}, {'measure': 'pCR Rate (%) by Baseline Tumor Location Subgroup', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator.\n\nAn exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.'}, {'measure': 'pCR Rate (%) by Steroid Use Subgroup', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. Steroids use: Yes was defined as participants with any steroid (ATC2 class corticosteroids for systemic use) from within 30 days of the first dose of sotigalimab to up to 7 days after the first dose and participants not fulfilling previous requirements are defined as Steroids use: No.\n\nAn exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.'}, {'measure': 'pCR Rate (%) by Surgery Subgroup', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator.\n\nThe subgroup of participants who had surgery before or at 16/17 weeks were defined as start of study treatment to surgery date from the surgical resection form, less than or equal to 17 weeks (119 days = 17 weeks \\* 7 days) or participants who were scheduled to have surgery but had their procedure aborted due to progressive disease at the time of the procedure or immediately before and did not have surgery because of metastasis. The subgroup of participants who had surgery after Week 17 were defined as start of study treatment to surgery date from the surgical resection form, greater than 17 weeks.\n\nAn exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.'}], 'secondaryOutcomes': [{'measure': 'Rate (%) of R0 Resection Overall', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'R0 was defined as the absence of gross and microscopic tumor involvement in the surgical margins i.e., no tumor remains following surgery. Rate of R0 resection was defined as the percentage of participants who achieved R0 following surgical resection.'}, {'measure': 'Rate (%) of R0 Resection by Baseline Histologic Subgroup', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'R0 was defined as the absence of gross and microscopic tumor involvement in the surgical margins i.e., no tumor remains following surgery. Rate of R0 resection was defined as the percentage of participants who achieved R0 following surgical resection.'}, {'measure': 'Pathologic Stage at Time of Surgery', 'timeFrame': 'At time of surgery, up to a maximum of 261 days', 'description': 'Pathologic staging was assessed via ypTNM (after chemoRT and surgery):\n\n* Tumor Stage (TX, T0, T1, T1a, T1b, T2, T3, T4, T4a, T4b) refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it had grown into the wall of the esophagus.\n* Node Stage (NX, N0, N1, N2, N3) refers to the number and location of lymph nodes that cancer has spread to. The higher the number after the N, the more lymph nodes that contained cancer cells.\n* Metastasis Stage (M0, M1) refers to whether the cancer had not spread (M0) or spread (M1) to other parts of the body.\n* Stage group (0, I, IA, IB, II, IIA, IIB, III, IIIA, IIIB, IV, IVA, IVB) are based on the TNM stages detailed above. The higher the number, the more advanced the cancer was.\n\nFor each category, a lower stage/group represents a better outcome.'}, {'measure': 'Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall', 'timeFrame': 'At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively)', 'description': 'Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas.\n\nAs the population does not typically have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST), radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable).'}, {'measure': 'Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup', 'timeFrame': 'At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively)', 'description': 'Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas.\n\nAs the population does not typically have measurable disease by RECIST, radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable).'}, {'measure': 'Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup', 'timeFrame': 'At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively)', 'description': 'Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas.\n\nAs the population does not typically have measurable disease by RECIST, radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable).'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to approximately 20 weeks', 'description': 'TEAEs were defined as adverse events which started on or after the first infusion of study treatment (Carboplatin/Paclitaxel/Sotigalimab/Radiotherapy) until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first. Laboratory values that were considered clinically significant were reported as adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophagus', 'gastroesophageal junction', 'T1-3N0-1', 'GE junction'], 'conditions': ['Esophageal Cancer', 'GastroEsophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '39907035', 'type': 'DERIVED', 'citation': 'Ko AH, Chao J, Noel MS, Shankaran V, Sohal D, Crow M, Oberstein PE, Scott AJ, McRee AJ, Rocha Lima CMSP, Fong L, Keenan BP, Soto M, Filbert EL, Hsu FJ, Yang X. A Phase 2 Study of Sotigalimab, a CD40 Agonist Antibody, plus Concurrent Chemoradiation as Neoadjuvant Therapy for Esophageal and Gastroesophageal Junction Cancers. Cancer Res Commun. 2025 Feb 1;5(2):349-357. doi: 10.1158/2767-9764.CRC-24-0513.'}]}, 'descriptionModule': {'briefSummary': "This pilot phase II trial studies the therapeutic effects and side effects of CD40 agonistic monoclonal antibody APX005M when combined with chemotherapy and radiation therapy, and to see how well they work to reduce or remove esophageal or gastroesophageal (GE) cancers when given before surgery in treating patients with esophageal cancer or GE cancer than can be removed by surgery. APX005M is intended to stimulate the body's own immune system so that the immune cells can more effectively invade and destroy the tumor, adding to the benefits of the chemotherapy and radiation therapy. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving APX005M, chemotherapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.", 'detailedDescription': 'Primary Objective:\n\nTo assess the efficacy of this novel combination, as measured by the pathologic complete response (pCR) rate.\n\nSecondary Objectives:\n\n1. To further characterize the safety and feasibility of combining APX005M with SOC chemoradiation (external beam radiation in daily fractions, with concurrent weekly low-dose carboplatin/paclitaxel) in the neoadjuvant setting for patients with resectable esophageal and GE junction cancers.\n2. To assess the efficacy of combining APX005M with SOC chemoradiation as measured by rates of R0 resection (microscopically negative margins, i.e., no tumor remains following surgery); and radiographic/metabolic response to neoadjuvant treatment on CT-PET.\n\nExploratory Objectives:\n\n1. To identify possible predictive molecular or immune-based efficacy biomarkers for this novel combination.\n2. To characterize and assess overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years of age.\n2. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the esophagus or GE junction.\n3. Surgically resectable (T1-3 Nx preferably by endoscopic ultrasound \\[EUS\\]). (Excluded: T1N0 tumors, cervical esophageal location, tumors invading the tracheobronchial tree or with fistula, distant disease that cannot be included in the radiation field or be resected at the time of esophagectomy).\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n5. Adequate hematological, renal, and hepatic parameters.\n\nExclusion Criteria:\n\n1. Any history of or current hematologic malignancy.\n2. History of a second primary cancer is allowed in the event the cancer is curatively resected and there is no evidence of recurrence/metastatic disease x 1 year. Subjects who have a history of cervical or breast carcinoma in situ, localized prostate cancer, adequately treated basal cell or squamous cell carcinoma of the skin, or superficial bladder tumors \\[Ta, Tis \\& T1\\] are also allowed.\n3. Major surgery within 4 weeks of first dose of investigational product.\n4. Prior or concurrent treatment with any anticancer agent for the same cancer diagnosis.\n5. Prior exposure to any immuno-oncology agents, including CD40/PD-1/PD-L1/CTLA-4 inhibitors (if any ambiguity, should be discussed with study principal investigator).\n6. History of bone marrow transplantation.\n7. History of autoimmune disorders with the exception of vitiligo or autoimmune thyroid disorders.\n8. Chronic steroid dependency (prednisone equivalent \\> 10 mg/day). Any steroid use should be discontinued at least 2 weeks prior to initiation of study treatment.\n9. Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months before first dose.\n10. Known human immunodeficiency virus (HIV) infection.'}, 'identificationModule': {'nctId': 'NCT03165994', 'briefTitle': 'APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apexigen America, Inc.'}, 'officialTitle': 'A Phase 2 Study of APX005M in Combination With Concurrent Chemoradiation as Neoadjuvant Therapy for Resectable Esophageal and Gastroesophageal Junction Cancers', 'orgStudyIdInfo': {'id': 'APX005M-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APX005M With Standard of Care Chemoradiation', 'description': 'Participants will receive standard of care chemoradiation, consisting of:\n\n* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.\n* Carboplatin (area under the carboplatin plasma concentration versus time curve = 2) and paclitaxel (50 mg/m\\^2) chemotherapy intravenously (IV) over 1 hour, once weekly, from Weeks 1-5.\n\nThe participants also will receive concurrent 0.3 mg/kg APX005M IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoradiation).\n\nSurgical resection of the tumor will be planned from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant is enrolled.', 'interventionNames': ['Drug: APX005M', 'Radiation: Radiation Therapy', 'Drug: Paclitaxel', 'Drug: Carboplatin', 'Procedure: Surgical resection of tumor']}], 'interventions': [{'name': 'APX005M', 'type': 'DRUG', 'otherNames': ['CD40 Agonistic Monoclonal Antibody', 'PYX-107', 'Sotigalimab'], 'description': 'APX005M IV infusion', 'armGroupLabels': ['APX005M With Standard of Care Chemoradiation']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Radiotherapy'], 'description': 'Radiation therapy, total dose 5040cGy in 180cGy fractions', 'armGroupLabels': ['APX005M With Standard of Care Chemoradiation']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': 'Paclitaxel IV infusion', 'armGroupLabels': ['APX005M With Standard of Care Chemoradiation']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'description': 'Carboplatin IV infusion', 'armGroupLabels': ['APX005M With Standard of Care Chemoradiation']}, {'name': 'Surgical resection of tumor', 'type': 'PROCEDURE', 'otherNames': ['Surgery', 'Operation'], 'description': 'Surgical removal of the tumor will occur between weeks 10-17', 'armGroupLabels': ['APX005M With Standard of Care Chemoradiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20007-2113', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Georgetown University Hospital (MGUH)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599-7305', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Renovatio Clinical', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apexigen America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}