Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-01-25 @ 3:47 AM
Study NCT ID:
NCT03836105
Status:
COMPLETED
Last Update Posted:
2025-10-15
First Post:
2019-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CemiplimAb Survivorship Epidemiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627974', 'term': 'cemiplimab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2019-02-07', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to 36 months', 'description': 'The rate of complete responses (CR) or partial responses (PR), as assessed by investigators'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to 36 months', 'description': 'Percentage of patients who have achieved CR, PR or stable disease (SD) to cemiplimab as assessed by investigators'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 36 months', 'description': 'Time from the time of initial response until documented tumor progress, death, or initiation of non-cemiplimab CSCC or BCC treatment'}, {'measure': 'Time to response', 'timeFrame': 'Up to 36 months', 'description': 'Time from date of first admission of cemiplimab to the initial response'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Up to 36 months', 'description': 'Time from the date of first administration of cemiplimab to progression or death from any cause, whichever occurs first'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 36 months', 'description': 'Time from the date of first administration of cemiplimab to the date of death due to any cause'}, {'measure': 'Time to treatment failure (TTTF)', 'timeFrame': 'Up to 36 months', 'description': 'Time from date of first administration of cemiplimab to treatment discontinuation for disease progression, treatment toxicity, or death'}, {'measure': 'Disease specific death (DSD)', 'timeFrame': 'Up to 36 months', 'description': 'Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators'}, {'measure': 'Number of patients with metastatic vs locally advanced cancer summarized every three weeks', 'timeFrame': 'Up to 36 months', 'description': 'Pattern of recurrence'}, {'measure': 'Immune related adverse events (irAEs)', 'timeFrame': 'Up to 36 months', 'description': 'Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5'}, {'measure': 'Infusion related reactions (IRRs)', 'timeFrame': 'Up to 36 months', 'description': 'NCI-CTCAE v5'}, {'measure': 'Treatment related serious adverse reactions (SARs)', 'timeFrame': 'Up to 36 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Locally Advanced CSCC (laCSCC)', 'Metastatic CSCC (mCSCC)', 'Locally Advanced BCC (laBCC)', 'Metastatic BCC (mBCC)'], 'conditions': ['Cutaneous Squamous Cell Carcinoma', 'Basal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '39797702', 'type': 'DERIVED', 'citation': 'Park SJ, Ellison DM, Weight R, Homsi J, Rabinowits G, Ruiz ES, Strasswimmer J, Simmons J, Panella T, Quek RG, Pouliot JF, Khushalani NI. CASE (CemiplimAb-rwlc Survivorship and Epidemiology): a study in advanced basal cell carcinoma. Future Oncol. 2025 Feb;21(4):431-436. doi: 10.1080/14796694.2024.2448416. Epub 2025 Jan 11.'}, {'pmid': '31951149', 'type': 'DERIVED', 'citation': 'Migden MR, Chandra S, Rabinowits G, Chen CI, Desai J, Seluzhytsky A, Sasane M, Campanelli B, Chen Z, Freeman ML, Ibrahim SF, Khushalani NI, Andria M, Ruiz E. CASE (CemiplimAb-rwlc Survivorship and Epidemiology) study in advanced cutaneous squamous cell carcinoma. Future Oncol. 2020 Feb;16(4):11-19. doi: 10.2217/fon-2019-0762. Epub 2020 Jan 17.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of the study are:\n\n* To describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (Q3W) for treatment of patients with advanced (defined as locally advanced or metastatic \\[nodal or distant\\]) cutaneous squamous cell carcinoma (CSCC) and patients with advanced (defined as locally advanced or metastatic \\[nodal or distant\\]) basal cell carcinoma (BCC) in real-world clinical settings\n* To evaluate the safety of cemiplimab based on incidence of treatment related immune-related adverse events (irAEs), infusion related reactions (IRRs), and treatment related serious adverse reactions (TSARs) in patients with advanced CSCC and patients with advanced BCC receiving cemiplimab treatment in real world clinical settings\n* To describe patient experience, including patient reported quality of life (QOL) and functional status, and clinician reported performance status in a real-world setting for patients with advanced CSCC and patients with advanced BCC\n* To describe baseline characteristics that could potentially be associated with health-related outcomes for patients with advanced CSCC and patients with advanced BCC undergoing treatment with cemiplimab\n* To describe patients who receive cemiplimab as treatment for CSCC or BCC in a real-world setting\n* To describe real-world use patterns of cemiplimab for CSCC and BCC\n* To investigate the long-term effects and effectiveness of cemiplimab in patients with advanced CSCC or advanced BCC\n* To describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with advanced CSCC or advanced BCC, regardless of etiology, per available data\n* To describe the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC per available data\n* To describe the effectiveness of cemiplimab as a first-line (1L) or later systemic treatment in patients with advanced CSCC, regardless of etiology, per available data\n* To describe the effectiveness of cemiplimab in patients with advanced BCC based on treatment patterns (reason for discontinuation, treatment exposure, etc) of prior Hedgehog inhibitor (HHI) usage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in this study will include men and women ≥18 years of age who have recently initiated, or who plan to initiate treatment with commercially available cemiplimab for laCSCC/mCSCC or laBCC/mBCC in a real-world setting.', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Eligible for treatment with and prescribed cemiplimab for advanced CSCC or advanced BCC in accordance with approved prescribing information as described in the protocol\n\nKey Exclusion Criteria:\n\n* Receiving cemiplimab for an indication other than advanced CSCC or advanced BCC\n* Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study\n* Patients concurrently participating in any study including administration of any investigational drug (including cemiplimab) or procedure (including survival follow up)\n\nNote: Other protocol defined Inclusion/Exclusion Criteria apply"}, 'identificationModule': {'nctId': 'NCT03836105', 'acronym': 'CASE', 'briefTitle': 'CemiplimAb Survivorship Epidemiology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'Cemiplimab Survivorship Epidemiology (CASE) Study', 'orgStudyIdInfo': {'id': 'R2810-ONC-1806'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'This group will enroll patients with advanced (defined as locally advanced or metastatic \\[nodal or distant\\]) CSCC.', 'interventionNames': ['Drug: cemiplimab']}, {'label': 'Group 2', 'description': 'This group will enroll patients with advanced (defined as locally advanced or metastatic \\[nodal or distant\\]) BCC.', 'interventionNames': ['Drug: cemiplimab']}], 'interventions': [{'name': 'cemiplimab', 'type': 'DRUG', 'otherNames': ['REGN2810', 'Libtayo'], 'description': 'No investigational agents will be provided to enrolled patients by the sponsor as part of this study. Patients will have recently initiated or be planning to initiate treatment with commercially available cemiplimab for advanced CSCC or advanced BCC in a real-world setting according to respective label indications. In addition to cemiplimab, patients may receive other therapies as deemed necessary by their physicians for the treatment of CSCC or BCC or comorbid conditions.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Oncology Specialties, PC - Clearview Cancer Institute', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Dignity Health St. Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'CARTI Cancer Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90502', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA/LA Biomedical Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "St. Mary's Medical Center", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94063', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Regeneron Research Facility', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'The Melanoma and Skin Cancer Institute', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '06040', 'city': 'Manchester', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Regional Cancer Care Associates, LLC', 'geoPoint': {'lat': 41.77593, 'lon': -72.52148}}, {'zip': '33745', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Integrity Clinical Research', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33770', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Regeneron Research Facility', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '33156', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Regeneron Research Facility', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Cancer Institute at Baptist Health, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31792', 'city': 'Thomasville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital', 'geoPoint': {'lat': 30.83658, 'lon': -83.97878}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '47374', 'city': 'Richmond', 'state': 'Indiana', 'country': 'United States', 'facility': 'Reid Oncology Association', 'geoPoint': {'lat': 39.82894, 'lon': -84.89024}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'CHRISTUS Highland Cancer Treatment Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Baltimore Veterans Affairs Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21702', 'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': 'Frederick Health', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Hospital & Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Southeast Nebraska Hematology & Oncology Consultants, PC', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Optum Cancer Care', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07202', 'city': 'Elizabeth', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Regeneron Research Facility', 'geoPoint': {'lat': 40.66399, 'lon': -74.2107}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Regeneron Research Facility', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Regeneron Research Facility', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10960', 'city': 'Nyack', 'state': 'New York', 'country': 'United States', 'facility': 'Regeneron Research Facility', 'geoPoint': {'lat': 41.09065, 'lon': -73.91791}}, {'zip': '11776', 'city': 'Port Jefferson Station', 'state': 'New York', 'country': 'United States', 'facility': 'New York Cancer and Blood Specialists', 'geoPoint': {'lat': 40.92538, 'lon': -73.04733}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Hospital', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Oncology Specialists of Charlotte, PA', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Asante Rogue Regional Medical Center', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Luke's University Health Network", 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Research Center of the Carolinas', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Charleston Hematology Oncology Associates, PA', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Medical Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Amarillo Cancer Center', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Renovatio Clinical', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Schar Cancer Institute', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '00902', 'city': 'Rio Piedras', 'country': 'Puerto Rico', 'facility': 'Pan-American Center for Oncology Trials, LLC', 'geoPoint': {'lat': 18.39745, 'lon': -66.04989}}, {'zip': '00927', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'FDI Clinical Research', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceutical, Inc.'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When Regeneron has:\n\n* received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development\n* made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)\n* the legal authority to share the data, and\n* ensured the ability to protect participant privacy', 'ipdSharing': 'YES', 'description': 'All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.', 'accessCriteria': "Qualified researchers can submit a proposal for access to 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'}}}}