Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT02600169
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2015-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of Response Markers and Adverse Events in Melanoma Patients Treated With Pembrolizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2015-11-03', 'studyFirstSubmitQcDate': '2015-11-06', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early serum response markers', 'timeFrame': 'up to day 126', 'description': 'Serum markers: S100B, LDH, white blood count differential neutrophils, monocytes, lymphocytes, eosinophils, basophils. Markers will be correlated to early response as measured by RECIST 1.1 criteria at week 12 and 18 of treatment with pembrolizumab.'}, {'measure': 'Predicitve patient characteristics', 'timeFrame': 'baseline', 'description': 'Patient characteristics: age, gender, WHO performance status'}, {'measure': 'Predictive tumor characteristics', 'timeFrame': 'baseline', 'description': 'Tumor characteristics: M-stage, presence of CNS metastases, mutation status, PD-L1 status.'}, {'measure': 'Adverse events of clinical interest will be collected and graded according to the CTCAE version 4.0 criteria', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '2 years', 'description': 'Overall survival will be evaluated for all patients treated with pembrolizumab.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.', 'detailedDescription': 'This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma.', 'healthyVolunteers': False, 'eligibilityCriteria': 'All patients that were eligible for treatment with pembrolizumab in the Named Patient Program in the Netherlands.'}, 'identificationModule': {'nctId': 'NCT02600169', 'briefTitle': 'Retrospective Analysis of Response Markers and Adverse Events in Melanoma Patients Treated With Pembrolizumab', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Retrospective Analysis of Response Markers and Adverse Events in a Nationwide Cohort of Advanced Melanoma Patients Treated With Pembrolizumab', 'orgStudyIdInfo': {'id': '20150907'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with pemprolizumab', 'description': 'All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma. Patients will be included from all 14 WIN-O (Werkgroep Immunologie Nederland voor Oncologie) centers in the Netherlands. Patients are at least 18 years of age.', 'interventionNames': ['Drug: Pemprolizumab']}], 'interventions': [{'name': 'Pemprolizumab', 'type': 'DRUG', 'otherNames': ['MK3475'], 'description': 'All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma.', 'armGroupLabels': ['Patients treated with pemprolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'G.A.P. Hospers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}