Viewing Study NCT04916002

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Ignite Creation Date: 2025-12-25 @ 3:52 AM

Ignite Modification Date: 2025-12-26 @ 2:41 AM

Study NCT ID: NCT04916002

Status: TERMINATED

Last Update Posted: 2025-12-05

First Post: 2021-06-01

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015266', 'term': 'Carcinoma, Merkel Cell'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627974', 'term': 'cemiplimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643', 'title': 'Clinical Trials Administrator', 'organization': 'Regeneron Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Terminated early due to study drug supply. Enrolled 77 of 225 planned participants. Participants only enrolled in CSCC, MCC, \\& BCC cohorts at time of diagnosis. Results descriptive in nature. No conclusions can be inferred from cohorts analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'From signing of informed consent through end of study up to approximately 31.5 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A1: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 24, 'seriousNumAtRisk': 25, 'deathsNumAffected': 8, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Cohort A2: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 8, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Cohort B1: CMP-001+Cemiplimab for MCC', 'description': 'Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 4, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Cohort B2: CMP-001+Cemiplimab for MCC', 'description': 'Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'deathsNumAffected': 9, 'seriousNumAffected': 11}, {'id': 'EG004', 'title': 'Cohort D: CMP-001+Cemiplimab for BCC', 'description': 'Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \\[PD-L1\\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 29, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 24, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 24, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 19, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Localised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Axillary pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Crepitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Infusion site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Constipation', 'stats': 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'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule'}, {'id': 'OG001', 'title': 'Cohort A2: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG002', 'title': 'Cohort B1: CMP-001+Cemiplimab for MCC', 'description': 'Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG003', 'title': 'Cohort B2: CMP-001+Cemiplimab for MCC', 'description': 'Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG004', 'title': 'Cohort D: CMP-001+Cemiplimab for BCC', 'description': 'Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \\[PD-L1\\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}], 'classes': [{'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '65.1'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '26.0'}, {'value': '46.2', 'groupId': 'OG002', 'lowerLimit': '19.2', 'upperLimit': '74.9'}, {'value': '6.3', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '30.2'}, {'value': '25.0', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '80.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 31.5 Months', 'description': 'ORR is defined as the Percent of participants with a confirmed objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all enrolled participants who received any study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule'}, {'id': 'OG001', 'title': 'Cohort A2: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG002', 'title': 'Cohort B1: CMP-001+Cemiplimab for MCC', 'description': 'Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG003', 'title': 'Cohort B2: CMP-001+Cemiplimab for MCC', 'description': 'Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG004', 'title': 'Cohort D: CMP-001+Cemiplimab for BCC', 'description': 'Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \\[PD-L1\\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Any TEAE leading to discontinuation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any TEAE leading to death', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 31.5 months', 'description': 'Number of participants with any treatment-emergent adverse event (TEAE), any serious TEAE, and any TEAE leading to discontinuation or death reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAF) included all enrolled participants who received any study drug.'}, {'type': 'SECONDARY', 'title': 'Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule'}, {'id': 'OG001', 'title': 'Cohort A2: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG002', 'title': 'Cohort B1: CMP-001+Cemiplimab for MCC', 'description': 'Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG003', 'title': 'Cohort B2: CMP-001+Cemiplimab for MCC', 'description': 'Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG004', 'title': 'Cohort D: CMP-001+Cemiplimab for BCC', 'description': 'Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \\[PD-L1\\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}], 'classes': [{'title': 'Grade 1 Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 2 Moderate', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Severe', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Grade 4 Life-threatening', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 5 Death', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 31.5 months', 'description': 'Number of participants per NCI CTCAE version 5.0 Adverse Event Grade reported:\n\nGrade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living Grade 4 Life-threatening consequences: urgent intervention indicated Grade 5 Death related to adverse event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAF) included all enrolled participants who received any study drug.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule'}, {'id': 'OG001', 'title': 'Cohort A2: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG002', 'title': 'Cohort B1: CMP-001+Cemiplimab for MCC', 'description': 'Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG003', 'title': 'Cohort B2: CMP-001+Cemiplimab for MCC', 'description': 'Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG004', 'title': 'Cohort D: CMP-001+Cemiplimab for BCC', 'description': 'Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \\[PD-L1\\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'comment': 'Insufficient number of participants with events for estimated upper confidence interval', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median duration of DOR not reached; Insufficient number of participants with events for estimated lower and upper confidence interval', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median duration of DOR not reached; Insufficient number of participants with events for estimated upper confidence interval', 'groupId': 'OG002', 'lowerLimit': '4.2', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median duration of DOR not reached; Insufficient number of participants with events for estimated lower and upper confidence interval', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median duration of DOR not reached; Insufficient number of participants with events for estimated lower and upper confidence interval', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 31.5 months', 'description': 'DOR is defined as the time from date of first documented response (CR or PR) to date of documented progressive disease (PD), based on RECIST v1.1, per investigator', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed for DOR included only participants with confirmed complete response (CR) or partial response (PR)'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule'}, {'id': 'OG001', 'title': 'Cohort A2: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG002', 'title': 'Cohort B1: CMP-001+Cemiplimab for MCC', 'description': 'Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG003', 'title': 'Cohort B2: CMP-001+Cemiplimab for MCC', 'description': 'Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG004', 'title': 'Cohort D: CMP-001+Cemiplimab for BCC', 'description': 'Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \\[PD-L1\\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'comment': 'Insufficient number of participants with events for estimated upper confidence interval', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': 'NA'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '3.9'}, {'value': '10.4', 'comment': 'Insufficient number of participants with events for estimated upper confidence interval', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': 'NA'}, {'value': '3.7', 'comment': 'Insufficient number of participants with events for estimated upper confidence interval', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median duration of PFS not reached; Insufficient number of participants with events for estimated upper confidence interval', 'groupId': 'OG004', 'lowerLimit': '2.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 31.5 months', 'description': 'PFS is defined as the time from date of first dose of study treatment to date of documented PD based on RECIST v1.1 or death, whichever occurs first', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all enrolled participants who received any study drug.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule'}, {'id': 'OG001', 'title': 'Cohort A2: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG002', 'title': 'Cohort B1: CMP-001+Cemiplimab for MCC', 'description': 'Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG003', 'title': 'Cohort B2: CMP-001+Cemiplimab for MCC', 'description': 'Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'OG004', 'title': 'Cohort D: CMP-001+Cemiplimab for BCC', 'description': 'Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \\[PD-L1\\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'comment': 'Insufficient number of participants with events for estimated upper confidence interval', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': 'NA'}, {'value': '12.7', 'comment': 'Insufficient number of participants with events for estimated upper confidence interval', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median duration of PFS not reached; Insufficient number of participants with events for estimated upper confidence interval', 'groupId': 'OG002', 'lowerLimit': '10.9', 'upperLimit': 'NA'}, {'value': '9.9', 'comment': 'Insufficient number of participants with events for estimated upper confidence interval', 'groupId': 'OG003', 'lowerLimit': '4.9', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median duration of PFS not reached; Insufficient number of participants with events for estimated lower and upper confidence interval', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 31.5 months', 'description': 'OS is defined as the time from date of first dose of study treatment to date of death', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all enrolled participants who received any study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A1: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule'}, {'id': 'FG001', 'title': 'Cohort A2: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'FG002', 'title': 'Cohort B1: CMP-001+Cemiplimab for MCC', 'description': 'Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'FG003', 'title': 'Cohort B2: CMP-001+Cemiplimab for MCC', 'description': 'Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'FG004', 'title': 'Cohort D: CMP-001+Cemiplimab for BCC', 'description': 'Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \\[PD-L1\\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'End of trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Participant non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A1: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule'}, {'id': 'BG001', 'title': 'Cohort A2: CMP-001+Cemiplimab for CSCC', 'description': 'Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'BG002', 'title': 'Cohort B1: CMP-001+Cemiplimab for MCC', 'description': 'Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'BG003', 'title': 'Cohort B2: CMP-001+Cemiplimab for MCC', 'description': 'Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'BG004', 'title': 'Cohort D: CMP-001+Cemiplimab for BCC', 'description': 'Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \\[PD-L1\\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'spread': '14.09', 'groupId': 'BG000'}, {'value': '67.9', 'spread': '9.42', 'groupId': 'BG001'}, {'value': '71.0', 'spread': '11.55', 'groupId': 'BG002'}, {'value': '69.2', 'spread': '13.20', 'groupId': 'BG003'}, {'value': '54.5', 'spread': '9.40', 'groupId': 'BG004'}, {'value': '68.8', 'spread': '12.46', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '54', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'American Indian / Alaskan Native', 'categories': [{'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': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'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': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'description': 'Race Customized', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '70', 'groupId': 'BG005'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'description': 'Ethnicity Customized', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-19', 'size': 1216859, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-30T10:17', 'hasProtocol': True}, {'date': '2024-11-19', 'size': 390206, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-30T10:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'whyStopped': 'Sponsor Decision related to study drug supply', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2021-06-01', 'resultsFirstSubmitDate': '2025-10-30', 'studyFirstSubmitQcDate': '2021-06-01', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-20', 'studyFirstPostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 31.5 Months', 'description': 'ORR is defined as the Percent of participants with a confirmed objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death', 'timeFrame': 'Up to 31.5 months', 'description': 'Number of participants with any treatment-emergent adverse event (TEAE), any serious TEAE, and any TEAE leading to discontinuation or death reported.'}, {'measure': 'Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)', 'timeFrame': 'Up to 31.5 months', 'description': 'Number of participants per NCI CTCAE version 5.0 Adverse Event Grade reported:\n\nGrade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living Grade 4 Life-threatening consequences: urgent intervention indicated Grade 5 Death related to adverse event'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 31.5 months', 'description': 'DOR is defined as the time from date of first documented response (CR or PR) to date of documented progressive disease (PD), based on RECIST v1.1, per investigator'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 31.5 months', 'description': 'PFS is defined as the time from date of first dose of study treatment to date of documented PD based on RECIST v1.1 or death, whichever occurs first'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 31.5 months', 'description': 'OS is defined as the time from date of first dose of study treatment to date of death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vidutolimod', 'Metastatic Cancer', 'Advanced Cancer', 'MCC', 'CSCC', 'BCC', 'TNBC', 'NSCLC', 'OPSCC'], 'conditions': ['Merkel Cell Carcinoma', 'Cutaneous Squamous Cell Carcinoma', 'Basal Cell Carcinoma', 'Triple Negative Breast Cancer', 'Non-Small Cell Lung Cancer', 'Oropharynx Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': "The goal of this study is to learn if giving cemiplimab and vidutolimod together could be effective in treating advanced cancer. The main questions it aims to answer are:\n\n* How many participants' cancers respond to vidutolimod together with cemiplimab?\n* Is vidutolimod together with cemiplimab safe and well-tolerated?\n* How well does vidutolimod together with cemiplimab treat participants' cancer?\n\nParticipants will receive trial treatment for up to 2 years. 30 days after stopping treatment, participants will have a follow-up visit. After that visit, the trial staff will continue to follow up with participants about every 3 months, until the trial ends.", 'detailedDescription': 'Former Sponsor Checkmate Pharmaceuticals Note: Early termination planned on 31Oct2024 due to study drug supply'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\nParticipants enrolled in the study must meet all of the following inclusion criteria to be eligible.\n\n1. Histopathologically-confirmed diagnosis of cancer, as defined by the protocol.\n2. Measurable disease, as defined by RECIST v1.1 and as defined in the protocol. Note: CSCC, MCC and BCC subjects without radiographically measurable disease are not excluded if there is at least 1 lesion ≥ 10 mm in at east 1 dimension documented by color photography.\n3. Adequate organ function based on most recent laboratory values within 3 weeks before first dose of study treatment on Week 1 Day 1 (W1D1), as defined in the protocol.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening.\n\nKey Exclusion Criteria:\n\nParticipants presenting with any of the following will not qualify for entry into the study:\n\n1. Received radiation therapy (or other non-systemic therapy) within 2 weeks before first dose of study treatment on W1D1. Participants should have recovered (i.e. Grade ≤ 1 or at baseline) from radiation-related toxicities.\n2. Had major surgeries (including complete oncologic resection) within last 4 weeks prior to enrollment, and/or have not recovered adequately from the toxicities and/or complications from the intervention. Minor surgeries (including routine resections of early stage CSCCs and BCCs that may be due to field cancerization) require a 7-day washout.\n3. Received systemic pharmacologic doses of corticosteroids \\> 10 mg/day prednisone within 15 days before first dose of study treatment on W1D1, as defined in the protocol.\n4. History of immune-mediated AE leading to permanent discontinuation due to prior PD-1-blocking antibody.\n5. Not fully recovered from AEs due to prior treatment (to Grade 1 or less, per Common Terminology Criteria for Adverse Events (CTCAE), with the exception of persistent vitiligo, alopecia, hypothyroidism, diabetes mellitus, and adrenal and/or pituitary insufficiency.\n6. Active pneumonitis or history of noninfectious pneumonitis that required steroids.\n7. Severe uncontrolled medical disease within 12 months of screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis, cerebrovascular accident, or implanted or continuous use of a pacemaker or defibrillator, or emphysema with FEV1 ≤ 50% predicted.\n8. Known history of immunodeficiency.\n9. Known additional malignancy that is progressing or required active treatment within the past 3 years, as defined in the protocol.\n10. Active autoimmune disease that required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment.\n11. Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors).\n\nNOTE: Other protocol defined Inclusion/Exclusion Criteria apply'}, 'identificationModule': {'nctId': 'NCT04916002', 'briefTitle': 'A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Open-label, Phase 2 Study of Intratumoral Vidutolimod (CMP-001) in Combination With Intravenous Cemiplimab in Subjects With Selected Types of Advanced or Metastatic Cancer', 'orgStudyIdInfo': {'id': 'CMP-001-009'}, 'secondaryIdInfos': [{'id': '2023-507344-36-01', 'type': 'REGISTRY', 'domain': 'EUCT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vidutolimod and cemiplimab for cutaneous squamous cell carcinoma (CSCC) (A1)', 'description': 'Participants who have not received prior systemic therapy for metastatic or locally and/or regionally advanced unresectable CSCC and who are not eligible for curative radiation will receive vidutolimod intratumoral(ly) (IT) and cemiplimab intravenous (IV) according to the treatment schedule until a reason for treatment discontinuation is reached.', 'interventionNames': ['Drug: vidutolimod', 'Drug: cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'Vidutolimod and cemiplimab for CSCC (A2)', 'description': 'Participants who have progressed while receiving a programmed cell death protein 1 (PD-1)-blocking antibody or within 12 weeks of discontinuation of PD-1 blocking antibody for metastatic or locally and/or regionally advanced unresectable CSCC, will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.', 'interventionNames': ['Drug: vidutolimod', 'Drug: cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'Vidutolimod and cemiplimab for Merkel cell carcinoma (MCC) (B1)', 'description': 'Participants who have not received prior systemic therapy for metastatic or locally and/or regionally advanced unresectable MCC will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.', 'interventionNames': ['Drug: vidutolimod', 'Drug: cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'Vidutolimod and cemiplimab for MCC (B2)', 'description': 'Participants who have progressed while receiving a PD-1-blocking antibody or within 12 weeks of discontinuation of the PD-1 blocking antibody, will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.', 'interventionNames': ['Drug: vidutolimod', 'Drug: cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'Vidutolimod and cemiplimab for triple negative breast cancer (TNBC) (C1)', 'description': 'Participants who have not received prior therapy with immune checkpoint inhibitors (iCPIs) and who must have previously received treatment with sacituzumab govitecan (all advanced or metastatic TNBC participants), with trastuzumab deruxtecan \\[human epidermal growth factor receptor 2 (HER2)-low participants\\] and with adenosine diphosphate ribose polymerase (PARP) inhibitor \\[for BReast CAncer gene (BRCA)\\] for TNBC will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.', 'interventionNames': ['Drug: vidutolimod', 'Drug: cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'Vidutolimod and cemiplimab for TNBC (C2)', 'description': 'Participants who have previously received treatment with sacituzumab govitecan (all advanced or metastatic TNBC participants), with trastuzumab deruxtecan (HER2-low participants) and with PARP inhibitor (for BRCA) and who have progressed while receiving a PD-1-blocking antibody or within 12 weeks of discontinuation of a PD-1 blocking antibody for advanced or metastatic TNBC, will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.', 'interventionNames': ['Drug: vidutolimod', 'Drug: cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'Vidutolimod and cemiplimab for basal cell carcinoma (BCC) (D)', 'description': 'Participants who have not received prior hedgehog pathway inhibitor therapy, or prior anti-PD-1/programmed cell death ligand 1 (PD-L1) therapy and who do not wish to receive or who are not candidates for a hedgehog inhibitor, for metastatic or locally and/or regionally advanced unresectable BCC and will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.', 'interventionNames': ['Drug: vidutolimod', 'Drug: cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'Vidutolimod and cemiplimab for non-small cell lung cancer (NSCLC) (E)', 'description': 'Participants with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression \\[tumor proportion score (TPS) ≥50%\\] based on a prior PD-L1 result as determined by College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) (or equivalently licensed) lab, with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ros oncogene 1 (ROS1) aberrations, and who have not received prior anti-PD-1/PD-L1 therapy and are amenable to IT therapy and do not wish to receive chemotherapy.\n\nNote: this cohort is not conducted in Europe', 'interventionNames': ['Drug: vidutolimod', 'Drug: cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'Vidutolimod and cemiplimab for recurrent/metastatic Oropharynx Squamous Cell Carcinoma (OPSCC) (F)', 'description': 'Participants with PD-L1 combined positive score (CPS) ≥ 1, based on a prior PD-L1 result and human papillomavirus (HPV)-positive disease based on a prior result, who have not received prior systemic therapy for recurrent/metastatic disease. Participants will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.', 'interventionNames': ['Drug: vidutolimod', 'Drug: cemiplimab']}], 'interventions': [{'name': 'vidutolimod', 'type': 'DRUG', 'otherNames': ['CMP-001'], 'description': 'Participants will receive vidutolimod for up to 2 years as follows: 10 mg IT weekly for 7 doses after which vidutolimod will be administered every 3 weeks (Q3W). The first dose of vidutolimod may be administered subcutaneously (SC) or IT at the discretion of Investigator. All subsequent doses will be IT. The initial 7 doses of vidutolimod, delivered on a weekly dosing schedule, must be completed before starting the Q3W vidutolimod dosing schedule.', 'armGroupLabels': ['Vidutolimod and cemiplimab for CSCC (A2)', 'Vidutolimod and cemiplimab for MCC (B2)', 'Vidutolimod and cemiplimab for Merkel cell carcinoma (MCC) (B1)', 'Vidutolimod and cemiplimab for TNBC (C2)', 'Vidutolimod and cemiplimab for basal cell carcinoma (BCC) (D)', 'Vidutolimod and cemiplimab for cutaneous squamous cell carcinoma (CSCC) (A1)', 'Vidutolimod and cemiplimab for non-small cell lung cancer (NSCLC) (E)', 'Vidutolimod and cemiplimab for recurrent/metastatic Oropharynx Squamous Cell Carcinoma (OPSCC) (F)', 'Vidutolimod and cemiplimab for triple negative breast cancer (TNBC) (C1)']}, {'name': 'cemiplimab', 'type': 'DRUG', 'otherNames': ['Libtayo', 'REGN2810'], 'description': 'Participants will receive cemiplimab for up to 2 years as follows: 350 mg IV infusion over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.', 'armGroupLabels': ['Vidutolimod and cemiplimab for CSCC (A2)', 'Vidutolimod and cemiplimab for MCC (B2)', 'Vidutolimod and cemiplimab for Merkel cell carcinoma (MCC) (B1)', 'Vidutolimod and cemiplimab for TNBC (C2)', 'Vidutolimod and cemiplimab for basal cell carcinoma (BCC) (D)', 'Vidutolimod and cemiplimab for cutaneous squamous cell carcinoma (CSCC) (A1)', 'Vidutolimod and cemiplimab for non-small cell lung cancer (NSCLC) (E)', 'Vidutolimod and cemiplimab for recurrent/metastatic Oropharynx Squamous Cell Carcinoma (OPSCC) (F)', 'Vidutolimod and cemiplimab for triple negative breast cancer (TNBC) (C1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92037-0845', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'GenesisCare USA', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Health Cancer Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Cancer Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '20814', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'VA Maryland Health Care System', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Clinical Trial Office', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27858', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OU Health Stephenson Cancer Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Oncology Consultants', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United 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individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}