Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-09 @ 12:06 PM
Study NCT ID:
NCT02791594
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2016-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Imaging FDG Flare in Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.farwell@pennmedicine.upenn.edu', 'phone': '215-662-7750', 'title': 'Dr. Michael Farwell', 'organization': 'Abramson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality was monitored/assessed for up to 4 years. Adverse events were monitored/assessed for the period of time from the injection of FDG to the completion of the imaging exam (for 2 hours).', 'description': 'Adverse events related to the standard of care clinical treatment (pembrolizumab) were not collected or reported as part of this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Early FDG PET/CT Imaging Group', 'description': 'Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response by RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Early FDG PET/CT Imaging Group', 'description': 'Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.'}], 'classes': [{'categories': [{'title': 'Responders (complete response + partial response)', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Non-responders (progressive disease or pathologic non-response)', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Objective response is defined as the proportion of patients with a complete response or partial response by RECIST version 1.1. A complete response is defined as the disappearance of all tumor lesions, and a decrease in size of all pathological lymph nodes to \\<10 mm along the short axis. A partial response is at least a 30% decrease in the sum of diameters of target tumor lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change in Tumor FDG Uptake Between Baseline FDG PET/CT and Early On-Treatment FDG PET/CT Obtained 1 Week After Initiation of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Early FDG PET/CT Imaging Group', 'description': 'Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.'}], 'classes': [{'categories': [{'title': 'Metabolic Flare or Metabolic Response', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stable Metabolism', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 1 week after initiation of pembrolizumab', 'description': 'FDG PET scans were evaluated for changes in maximum standardized uptake value (SUVmax) for up to 5 RECIST-measurable lesions (2 per organ) for each patient. The percentage change in SUVmax was defined as (sum of PET1 SUVmax - sum of PET0 SUVmax)/(sum of PET0 SUVmax) x 100, where PET0 was the baseline FDG PET/CT and PET1 was the on-treatment FDG PET/CT acquired at \\~1 week after starting pembrolizumab. A metabolic flare (MF) was defined as \\>70% increase in tumor SUVmax between baseline and follow-up scans, and a metabolic response (MR) was defined as a \\>30% decrease in tumor SUVmax. If the change in tumor SUVmax was neither MF or MR it was classified as stable metabolism (SM).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Early FDG PET/CT Imaging Group', 'description': 'Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.'}], 'classes': [{'title': 'MF-MR cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median PFS was not reached in this cohort (but was \\>38 months) because there were an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'SM cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '5.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 years', 'description': 'Progression-Free Survival is defined as time from the PET1 scan (acquired 1 week after starting pembrolizumab) to progression, according to RECIST 1.1, or death from any cause, whichever occurs first. Patients who neither progress nor die during the study will be censored at the date of last disease assessment without progression.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is 19, but the progression-free survival was calculated for each cohort: MF-MR cohort (6 participants) and SM cohort (13 participants).'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Early FDG PET/CT Imaging Group', 'description': 'Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.'}], 'classes': [{'title': 'MF-MR cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'SM cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Overall Survival (OS) was defined as time from the PET1 scan (6-10 days after start of immunotherapy) to death from any cause, with patient censoring at date last known alive.', 'unitOfMeasure': 'percentage of patients that died', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is 19, but the overall survival was calculated for each cohort: MF-MR cohort (6 participants) and SM cohort (13 participants).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Early FDG PET/CT Imaging Group', 'description': 'Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Early FDG PET/CT Imaging Group', 'description': 'Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cancer Stage', 'classes': [{'title': 'Stage 3B', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Stage 3C', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Stage 4', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Stage 3 melanoma has spread to regional lymph nodes or has developed in-transit deposits of disease, but there is no evidence of distant metastasis; stage 3C melanoma is more advanced compared to Stage 3B. Stage 4 melanoma has traveled beyond the original tumor site and beyond the regional lymph nodes to more distant sites in the body.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-18', 'size': 540743, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-30T11:41', 'hasProtocol': True}, {'date': '2019-02-11', 'size': 232250, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-30T11:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2016-06-01', 'resultsFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2016-06-01', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-07', 'studyFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response by RECIST Version 1.1', 'timeFrame': '6 months', 'description': 'Objective response is defined as the proportion of patients with a complete response or partial response by RECIST version 1.1. A complete response is defined as the disappearance of all tumor lesions, and a decrease in size of all pathological lymph nodes to \\<10 mm along the short axis. A partial response is at least a 30% decrease in the sum of diameters of target tumor lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Number of Participants With Change in Tumor FDG Uptake Between Baseline FDG PET/CT and Early On-Treatment FDG PET/CT Obtained 1 Week After Initiation of Pembrolizumab', 'timeFrame': 'Baseline and 1 week after initiation of pembrolizumab', 'description': 'FDG PET scans were evaluated for changes in maximum standardized uptake value (SUVmax) for up to 5 RECIST-measurable lesions (2 per organ) for each patient. The percentage change in SUVmax was defined as (sum of PET1 SUVmax - sum of PET0 SUVmax)/(sum of PET0 SUVmax) x 100, where PET0 was the baseline FDG PET/CT and PET1 was the on-treatment FDG PET/CT acquired at \\~1 week after starting pembrolizumab. A metabolic flare (MF) was defined as \\>70% increase in tumor SUVmax between baseline and follow-up scans, and a metabolic response (MR) was defined as a \\>30% decrease in tumor SUVmax. If the change in tumor SUVmax was neither MF or MR it was classified as stable metabolism (SM).'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': '4 years', 'description': 'Progression-Free Survival is defined as time from the PET1 scan (acquired 1 week after starting pembrolizumab) to progression, according to RECIST 1.1, or death from any cause, whichever occurs first. Patients who neither progress nor die during the study will be censored at the date of last disease assessment without progression.'}, {'measure': 'Overall Survival', 'timeFrame': '4 years', 'description': 'Overall Survival (OS) was defined as time from the PET1 scan (6-10 days after start of immunotherapy) to death from any cause, with patient censoring at date last known alive.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metastatic Melanoma']}, 'descriptionModule': {'briefSummary': "Up to 35 adult patients with metastatic melanoma planning to start pembrolizumab will be enrolled in this study with a target enrollment of 30 evaluable subjects. Subjects will complete a baseline FDG PET/CT and an on-treatment FDG PET/CT after 1 week of pembrolizumab therapy. Subjects may also be a part of the Penn Melanoma Tissue Collection Program and then will be asked to have one additional tumor biopsy and one additional blood draw for the purposes of this imaging study. Changes in tumor FDG uptake between the baseline and early on-treatment FDG PET/CT scans will be correlated with blood and tissue results from the patient's medical records and from the data collected as part of the Penn Melanoma Tissue Collection Program and with outcomes including objective response, progression free survival, and overall survival."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Melanoma', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.\n* The subject must be ≥ 18 years of age on day of signing informed consent.\n* The subject must have biopsy proven or clinically documented advanced stage metastatic melanoma.\n* The subject must have measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT.\n* The subject must be recommended to start pembrolizumab.\n\nExclusion Criteria:\n\n* Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test at the time of the screening visit.\n* Subject is not able to tolerate imaging procedures in the opinion of the investigator or treating physician.\n* Subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Subject has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent as assessed by medical record review and/or self-reported.\n* Subject has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) as determined by medical record review.\n* Subject has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Subject has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected) as determined by medical record review.\n* Subject has known active central nervous system metastases and/or carcinomatous meningitis.\n\nNote: Subjects with previously treated brain metastases will be eligible to participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to receiving pembrolizumab and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment."}, 'identificationModule': {'nctId': 'NCT02791594', 'briefTitle': 'Imaging FDG Flare in Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Imaging the Flare Response With FDG PET/CT in Patients With Advanced Metastatic Melanoma on Pembrolizumab.', 'orgStudyIdInfo': {'id': 'UPCC 02616'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Patients were treated with pembrolizumab according to standard of care.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Michael Farwell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}